StemCell Therapy

Contrary to popular belief, arthritis isnt a single disease. Its a term used to refer to joint pain or joint disease. According to the National Arthritis Foundation, there are more than 100 different types of arthritis and related conditions. People of all ages, sexes and races have arthritis, and its the leading cause of disability in America.

April is Arthritis Awareness Month. Bayhealth Primary Care Sports Medicine Physician Melissa Mackel, DO, CAQSM, said weight loss and muscle strengthening can decrease the risk of developing arthritis. When the joint symptoms of arthritis are mild or moderate, they can be managed with regular physical activity, maintaining a healthy weight and strengthening the muscles around the joint for added support.

A recent study showed a 40 percent improvement in both pain and physical abilities of those with arthritis who exercise, she said. The more staggering statistic is that only about 10 percent of those with arthritis choose this option and one-third of those with arthritis don't report any physical activity at all in their spare time.

Dr. Mackel recommends going for daily walks and using strengthening equipment like rubber resistance bands to build lean muscle mass. When it comes to arthritis the 'move it or lose it' motto holds true in regards to range of motion and function, she said. Exercise is the first thing we recommend to help decrease the symptoms and slow the progression of the disease.

While there are other unalterable factors that contribute to arthritis such as gender, age, genetics, and injury, Bayhealth Orthopaedics offers a myriad of treatment options that are both non-operative and operative. For those with mild pain, Dr. Mackel suggests different types of in-office consultations for strengthening exercises and nutrition counseling. For patients with more severe pain, she offers injections such as a corticosteroid or Viscosupplementation, custom bracing to help offload the affected joint, or meeting with an experienced joint replacement specialist.

For more information on treatment options, visit bayhealth.org/orthopaedics. To find a Bayhealth physician to fit your needs, call 1-866-Bay-Docs to learn about providers in your area.

See the rest here:
Strengthening Muscle to Reduce Arthritic Pain - CapeGazette.com

April 05, 2017 16:00 ET | Source: Galapagos NV

multilang-release

First dosing triggers $10 million milestone payment from Gilead Mechelen, Belgium; 5 April 2017, regulated information - Galapagos NV (Euronext & NASDAQ: GLPG) announces dosing of the first patient with psoriatic arthritis in the EQUATOR Phase 2 study. This achievement triggers a $10 million milestone payment from Gilead to Galapagos.

The EQUATOR Phase 2 study will be a multi-center, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of the selective JAK1 inhibitor filgotinib in adult patients with moderately to severely active psoriatic arthritis.

Galapagos and Gilead entered into a global collaboration for the development and commercialization of filgotinib in inflammatory indications. In addition to the EQUATOR Phase 2 study in psoriatic arthritis and the TORTUGA Phase 2 study in ankylosing spondylitis led by Galapagos, Gilead initiated the FINCH Phase 3 program in rheumatoid arthritis, the DIVERSITY Phase 3 study in Crohn's disease, the SELECTION Phase 2b/3 study in ulcerative colitis in 2016 and leads the Phase 2 study in Sjgren's syndrome.

Filgotinib is an investigational drug and its efficacy and safety have not been established. For information about the studies with filgotinib: http://www.clinicaltrials.gov For more information about filgotinib: http://www.glpg.com/filgotinib

About Galapagos Galapagos (Euronext & NASDAQ: GLPG) is a clinical-stage biotechnology company specialized in the discovery and development of small molecule medicines with novel modes of action. Our pipeline comprises Phase 3, Phase 2, Phase 1, pre-clinical, and discovery programs in cystic fibrosis, inflammation, fibrosis, osteoarthritis and other indications. We have discovered and developed filgotinib: in collaboration with Gilead we aim to bring this JAK1-selective inhibitor for inflammatory indications to patients all over the world. Galapagos is focused on the development and commercialization of novel medicines that will improve people's lives. The Galapagos group, including fee-for-service subsidiary Fidelta, has approximately 510 employees, operating from its Mechelen, Belgium headquarters and facilities in The Netherlands, France, and Croatia. More information at http://www.glpg.com.

Contacts

+31 6 53 591 999

communications@glpg.com

Paul van der Horst Director IR & Business Development +31 6 53 725 199

This press release contains inside information within the meaning of Regulation (EU) No 596/2014 of the European Parliament and of the Council of 16 April 2014 on market abuse (market abuse regulation).

Forward-looking statements This release may contain forward-looking statements, including statements regarding Galapagos' strategic ambitions, the anticipated timing of clinical studies with filgotinib, and the progression and results of such studies. Galapagos cautions the reader that forward-looking statements are not guarantees of future performance. Forward-looking statements involve known and unknown risks, uncertainties and other factors which might cause the actual results, financial condition and liquidity, performance or achievements of Galapagos, or industry results, to be materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. In addition, even if Galapagos' results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Among the factors that may result in differences are the inherent uncertainties associated with competitive developments, clinical trial and product development activities and regulatory approval requirements (including that data from the ongoing and planned clinical research programs may not support registration or further development of Galapagos' product candidates due to safety, efficacy or other reasons), Galapagos' reliance on collaborations with third parties (including its collaboration partner for filgotinib, Gilead), and estimating the commercial potential of Galapagos' product candidates. A further list and description of these risks, uncertainties and other risks can be found in Galapagos' Securities and Exchange Commission (SEC) filings and reports, including in Galapagos' most recent annual report on form 20-F filed with the SEC and subsequent filings and reports filed by Galapagos with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. Galapagos expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation.

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Originally posted here:
Galapagos doses first psoriatic arthritis patient with filgotinib - GlobeNewswire (press release)

A stem cell treatment for heart failure patients is safe and shows early signs of effectiveness, according to a study published Wednesday.

The study was conducted by Japanese researchers in 27 patients, who received transplants of stem cells taken from their own thigh muscles. There were no major complications, and most patients showed considerable improvement in their symptoms.

The study was published in the open-access Journal of the American Heart Association. Dr Yoshiki Sawa of Osaka University Graduate School of Medicine was the senior author. It can be found at j.mp/stemheart.

However, two San Diego cardiologists who do stem cell research on heart disease cautioned that similar clinical trials have shown promise over the years, only to fail at the end for various reasons. There is no approved stem cell therapy for heart failure.

So while the trial itself appears to be well-conducted, the researchers are very far from actually proving their treatment is effective, said Dr. Richard Schatz of Scripps Health and Dr. Eric Adler of UC San Diego School of Medicine.

For one thing, the trial was small, they said, and larger trials are where the most rigorous scientific evaluations are made.

These early trials have looked beneficial in the past, Adler said. When we do the larger trials, the results are more equivocal.

Adler said the signs of efficacy in this trial are modest. For example, the change in ejection fraction, a measurement of efficiency in pumping blood, rose from 27 percent to 30 percent in 15 of the 27 patients. Their heart failure was associated with a lack of blood flow, or ischemia. The remaining non-ischemic patients actually had a slight decline.

The entire field of stem cell and regenerative therapy for heart disease has been a disappointment to date, Schatz said.

Weve been at it for 20 years now, and we dont have a product or a positive (late-stage) trial, so that tells you pretty much everything you need to know, he said. Its not for lack of trying or billions of dollars invested. Its just very, very difficult.

The cardiac field has had more success with other technologies, such as cardiac stents. Schatz is the co-inventor of the first stent.

In the study, the researchers acknowledge that previous attempts had only been modestly effective. They devised a method of producing sheets of muscle stem cells and attaching them to the inner layer of the sac that encloses the heart, a layer that rests directly on the heart surface.

The stem cell sheets stimulate healing by producing chemicals that stimulate cardiac regeneration, the study said. The cells themselves dont survive in the long term, but by the time they die they have served their purpose.

Loss of function

Heart failure is a progressive disease in which the heart gradually loses its ability to pump blood. This can be triggered by a heart attack or any other cause that damages the heart muscle.

When damaged heart muscle is replaced with scar tissue, as often happens, the heart loses pumping capacity. It becomes overstressed, and its output of blood declines. This limits the patients ability to engage in intensive physical activity. In advanced cases, patients may become bedridden.

Existing treatments include drugs and LVAD units, which take over some of the hearts function to relieve stress. Some drugs may help the heart work more efficiently, but none have been shown to improve heart failure by actually regenerating lost heart muscle.

Stem cell therapy is tested in patients who havent responded well to other treatments. Trials have been and are being conducted in San Diego area hospitals.

Scripps Health has been testing a cardiac stem cell therapy from Los Angeles-based Capricor. The cells, taken from donor hearts, are injected into the coronary artery, where they are expected to settle in the heart and encourage regrowth.

UC San Diego is testing a heart failure therapy from Teva Pharmaceutical Industries. It consists of bone marrow derived mesenchymal precursor cells. These can give rise to several different cell types, including muscle cells.

And many other trials are going on throughout the country and internationally.

Adler and Schatz said theres reason for optimism in the long run, as technologies improve.

Just because the other trials have been negative doesnt mean this technique wont be beneficial, Adler said. Its just too early to tell.

That said, Schatz emphasized that the nature of the three-phase clinical trial process means that the show-stoppers for a treatment typically appear late.

Tighter standards needed

Clean trials trials where we all agree that this is the patient population we want to look at, are needed, he said.

For example, heart failure comes in two types, he said. Ischemic heart failure is caused by heart attacks and blocked arteries, which impede blood flow. Non-ischemic heart failure can be caused by damage from diseases, such as a virus.

Non-ischemics can be younger people, in their 20s and 30s, while the ischemic patients are older. Mixing those patient groups in a single trial is a mistake, he said.

Theyre different animals, Schatz said.

Another pitfall is failing to screen carefully enough to enroll only patients likely to benefit, Schatz said.

You can have a patient who has chest pain, and coronary disease just incidentally, he said.

His shoulder or chest pain is from a virus. So he goes into the trial and gets a placebo injection in his arm of cortisone, and his arm pain goes away. And because hes in that placebo group, hes counted as a success the pain went away. It has nothing to do with his heart. Thats an extreme example, but we actually saw that happen.

In a failed gene therapy trial for heart disease, some patients apparently had received the injection in the wrong location, missing the heart muscle, Schatz said.

You assume they got the gene, but they didnt, Schatz said. The study was negative, and thats why I think it was negative.

Such errors dont show up in Phase 1 trials, Adler and Schatz said, because theyre focused on evaluating safety. And these early trials dont have many patients, there arent enough to comfortably determine the therapy is really effective.

By the last stage of the trial, these sources of error have often been identified and trial standards have tightened up. And thats when the faulty assumptions made early appear as the trial ends in failure.

Despite those forbidding hurdles, Adler said research should continue.

This disease is killing a lot of people. Theres not going to be enough hearts to go around for transplant. Theres six million Americans with heart failure, and theres 2,000 heart transplants a year. So coming up with novel regenerative cell-based therapy is something were still excited about.

bradley.fikes@sduniontribune.com

(619) 293-1020

Originally posted here:
Study: heart failure stem cell therapy safe, shows early signs of effectiveness - The San Diego Union-Tribune

Bangladeshi activist and city-based medical centres collaborate to provide life-saving treatment for the three patients.

A Navi Mumbai-based treatment centre used stem cell therapy for the first time on three Bangladeshi patients suffering from an incurable muscular dystrophy.

The trio have been suffering from a rare disease called Duchenne Muscular Dystrophy, which causes progressive muscle degeneration, since birth. The disease limits the lifespan of the patient to just 30 years.

The doctors took stem cells from the patients bone marrow in the hip bone, processed it and injected it back into their bodies. The coordinator between the patients and the treating centre, Avantika Patil said, The patients are also undergoing physiotherapy and occupational therapy while we wait for the results of the procedure to show.

The treatment was made possible by the efforts of a Bangladeshi activist, Noor Khan, a Mumbai-based organisation, Meditourz, which worked in collaboration with a brain and spine institute from Navi Mumbai, NeuroGen.

It was NeuroGen which learnt about the three patients from an article in the international media and offered to treat their disease.

Of the three patients, the youngest, Shorab (8) has a mild disorder. This early medical intervention is expected to make his life less painful. However, the other two patients, Abdus (24) and Rahinul (14) are at a progressive stage.

Their father, Tofazzal Hossain, had even sought mercy killing from Bangladesh government for the duo as he could not afford the cost of their treatment. The travel arrangements were made in coordination with the Indian government. Free round-trip tickets were offered to six persons the patients and their caretakers who accompanied them to Mumbai from Kolkata, by Air India.

Read the original:
Bangladeshi patients treated with stem cell therapy in city - Mumbai ... - Mumbai Mirror

The U.S. Food and Drug Administration (FDA) has approved a new study that will test the efficacy of a stem cell technique used on children suffering from congenital heart disease.

The study is being hosted by Boston Childrens Hospital and Mesoblast Limited, a regenerative medicine company based in Australia. Their 24-patient trial will test the efficacy of Mesoblasts proprietary allogenic mesenchymal precursor cells (MPCs) in a corrective heart surgery on children under the age of 5 that suffer from hypoplastic left heart syndrome (HLHS), according to an April 3 press release.

The new technique is designed to save more patients with HLHS because current treatment is not always effective. Right now physicians generally perform a single, ventricle palliation, which results in the patient using only the right ventricle to the support the hearts entire circulation. However, the treatment is usually only a temporary fix because the right ventricle will eventually tire out, putting the patient at an increased risk for sudden cardiac arrest.

In the randomized, controlled trial, researchers will inject Mesoblasts MPC-150-IM into the left ventricle during surgical recruitment procedures, which should improve ventricular mass and function and ultimately lead to a higher likelihood of biventricular conversion.

The objective of combining Boston Children Hospitals expertise in pioneering surgical approaches to treating hypoplastic heart syndrome with the regenerative potential of our lead cardiovascular product, MPC-150-IM, is to develop a highly innovative treatment for this complex congenital condition as well as other serious and life-threatening cardiac diseases in children, said Kenneth Brow, the senior clinical development executive and head of cardiovascular diseases at Mesoblast, in a statement.

Continue reading here:
Researchers will use stem cell therapy to grow heart muscle in new study - Cardiovascular Business

Editors Note: All opinion section content reflects the views of the individual author only and does not represent a stance taken by the Collegian or its editorial board.

Alongside embryonic stem cells and abortion, the practice of physician-assisted death is one of todays most contested bioethical issues. Those opposed to aid in dying argue that the practice is out of line with fundamental medical principles, mainly those based upon the oft-quoted Hippocratic Oath. Such a claim, however, is erroneous as modern-day Hippocratic Oaths are not identical iterations of the ancient Greek declaration. I would actually go so far as to argue that physician-assisted death is supported by contemporary physicians pledges. With this in mind, I believe we should view Death with Dignity not as an issue at all, but rather as a new, necessary form of treatment that has grown out of a rapidly evolving medical landscape.

Physician-assisted death (PAD) refers to a patients conscious decision to end their life by way of lethal substances using the direct or indirect involvement of a physician. A situation where this practice might be employed is in the case of terminal cancer. If the affected patient knows they are going to die within X number of months and does not wish to undergo painful chemotherapy and/or palliative treatments until then, they can hasten death with the help of a licensed physician.

Few statesonly six plus the District of Columbiahave legislation permitting physician-aided death. This is in large part due to persistent qualms about the supposedly immoral nature of helping someone die. A large part of these beliefs are influenced by religious dogma, especially in the Catholic Church, as well as pro-life political movements. But, particularly in the medical field, some argue that helping a patient reach lifes end diametrically opposes the primary tenets of the Hippocratic Oath: primum non nocere, or, first, do no harm.

There are twothings wrong with this argument.

First, the above mentioned phrase is not actually from Hippocrates eponymous oath but is believed to have come from his work, Of the Epidemics. Granted, there is similar language found in the actual Hippocratic Oath: I will use treatment to help the sick . . . but never with a view to injury and wrong-doing. The only reason I point out this discrepancy is to show that the argument of primum non nocereis not technically a part of the physicians pledge and thus should not be a major argument for anti-PAD oath-takers.

Secondly, many modern medical schools have their own versions of the Hippocratic Oath, drawing elements from the original text, while some do not require them at all. Thats not to say that some schools are more ethical than others, just that certain institutions view the practice of medicine in different waysas they should, for the field is subject to change as major advancements or discoveries are made.

The genuine Hippocratic Oath, written circa 400 BCE, stresses admirable values, such as treating patients with the best of ones skills, handing down medical knowledge to subsequent generations, and ensuring patient consent to treatment. But, some elements of the oath, such as those pertaining to religion or those forbidding abortions, fell by the wayside over the years. Some parts of the oath were adopted into modern versions, while others were omitted. These variations show not only a growing individualism in perception of medical practice, but epitomize the complexity and subjective nature of bioethics.

Interestingly, only 14 percent of modern day Hippocratic Oaths forbid euthanasia.If a doctor argues that they cannot perform PAD due to its conflict with a sworn pledge, it is statistically unlikely that their oath actually forbade the practice.

Even when discounting the semantics of Hippocratic Oaths, I firmly believe that we are the captains of our souls as well as our own bodies. If diagnosed with a terminal illness and given the option of: a) undergoing painful treatment until natural death, or b) ending things quickly in a relatively painless way, I am positive I would choose the latter. Wouldnt you?

But, dont just take my word for it. Six states and the District of Columbia have already legalized PAD, and it can be expected that number will increase in coming years. The growing level of acceptance can be seen on both ends of the patient-provider spectrum.

Patients have a number of reasons for supporting euthanasia: alleviation of negative side effects; regaining a sense of control over an otherwise ungovernable illness; and eliminating fears of the future, such as worsening quality of life and/or becoming a burden on loved ones.

Physicians too are able to see why support of PAD should be given. As medical practitioners, physicians aim to show every patient care and compassion, while also providing their best advice for course of treatment. To discount the compassionate nature of euthanasiaits literally giving a patient asked-for relief from painis to discount the shared message of all Hippocratic Oaths: to avoid wrongdoing towards the patient. If a sick person is suffering and a doctor has the ability to end that pain, why wouldnt they?

We shouldnt argue that PAD is wrong because it violates the Hippocratic Oath. Instead, we should debate why this practice is still inaccessible to so many who are suffering. Unfortunately, Im out of paper space, so thatll have to be a discussion for another day.

Note: I have chosen not to use the familiar term physician-assisted suicide due to its perpetuation of prejudice and negative sentiments towards individuals who choose to die with dignity.

Lauren Willson can be reached at letters@collegian and online at @LaurenKealani

Read the original:
Willson: Hippocrates would have supported euthanasia - Rocky Mountain Collegian

Anyone who has watched Channel 4s hit series One Born Every Minute will tell you that seeing new life come into the world can be pretty magical.

Carolyn Sayle and her daughters Neenah and Shauni Higgins can wholeheartedly attest to that.

Although they have been present at countless births , they are not midwives. They have an altogether different role but one that could potentially save someones life.

All three work for the charity Anthony Nolan as dedicated cord blood collectors.

Their job involves asking expectant mums to donate their umbilical cord blood which would usually be thrown away for use in stem cell transplants.

Such transplants are often used when a patient doesnt have a match from an adult donor, such as if the patient is from an ethnic minority background, because the young cells are more adaptable to different genetic types.

Shauni says: Donating cord blood can make the difference between life and death for somebody who is suffering from blood cancer or leukaemia and its risk-free for the mother and baby .

Carolyn, 55, was the first to start working for the charity in March 2014 after relocating from Manchester, where she was an IVF coordinator, to Saxmundham, Suffolk, to live with her partner Paul, 60.

She says: Id known about Anthony Nolan for years, having joined the register as a bone marrow donor during one of its first big recruitment drives in the 70s.

Its a really important job that we do, and it still fascinates me that something we would otherwise throw away could save someones life.

Carolyn, who is based at Kings College Hospital in London, says collection is the easiest part of the job. So far she has done 455.

Its the bit that comes before thats difficult, she says. The majority of expectant mothers dont even know they can donate their placentas and umbilical cord.

Most are already in labour so theyre not in the best frame of mind when we approach them. Youve got to have people skills and know when not to go in the look on their face will tell you.

Carolyn says she starts every shift never knowing what will happen.

Weve got ladies walking in constantly in all stages of labour, she says. We try to speak to them as they come in as well as keeping track of deliveries.

"It can be a bit hectic when youve got a few ladies pushing and you dont know which one youll collect from first.

Once a woman has consented, a cord collector will be there in the delivery room or in theatre if they are having a caesarean section.

After delivery, the cord and placenta are taken into a separate room. The collector has to massage the placenta and the blood drains through the cord into a collection bag before it is cryogenically frozen.

One of Carolyns cord collections was used in a transplant last year. She recalls: I thought, How fantastic is that? I was so proud and told Neenah and Shauni straight away.

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Staff arent told where a donation is issued in order to maintain confidentiality, but Anthony Nolan can track how patients are doing further down the line.

Carolyn says: Its early days with it only being last year so I havent heard anything yet.

Shauni, 23, was so impressed with her mums work she became a cord collector herself at St Marys Hospital, Manchester, last May.

Shauni, who lives in Bagley, Manchester, with partner Jordan, 28, explains: Id loved the few placements Id done working in hospitals, and quickly realised I found my dream job when I joined Anthony Nolan.

On my first day I went into theatre to see a c-section. It was amazing and the first time Ive ever seen a birth. Nothing prepares you.

She says one of the most difficult parts of the job is when women decide not to donate. It seems such a shame for something so valuable to go to waste, she says.

Nearly all the cords we collect get used for something those that arent clinical-grade are used in research.

Mum-of-one Neenah, 28, started working alongside her sister as a cord collector at St Marys last July after deciding on a career change after working as an Estee Lauder manager and make-up artist.

She donated her own cord blood when she gave birth to Penelope, 20 months, and says: Id heard so much about donating from mum and I wanted to give something back. I wanted to do something that helped people.

Neenah, who lives in Urmston, Greater Manchester, with fianc Ian, 30, now wears scrubs and no make-up to work. She says: A lot of the time I get blood on my face so I dont want to be worrying about smudging my foundation when I wipe it off.

But being on a maternity unit can be an emotional roller coaster.

She says: I had a lady who had been induced but she had a placentalabruption and was rushed into theatre for an emergency c-section. She lost a lot of blood so I couldnt do the collection and the baby was very poorly.

That was horrible. It does affect you because you build up a relationship with people. You can sometimes come home after a shift and have a cry.

Working together has brought about a bit of family rivalry.

Neenah says: Last week Shauni was saying shed extracted 235ml of blood and I said, Well, I got 240ml.

Shauni adds: We have a bit of a competition when it comes to the size of the collections. She beat me by five. I always beat mum though!

Donating cord blood is completely risk-free for mother and baby, and doesnt interfere with your birth plan.

Anthony Nolan can currently collect cord blood in four hospitals St Marys, Manchester; Kings College Hospital, London; Leicester Royal Infirmary and Leicester General Hospital.

You can only donate if youre giving birth at one of these hospitals and you cannot donate if you are having a home birth.

You can register your interest online before birth at anthonynolan.org .

Each mum who donates is given a baby bundle, which includes a certificate and babygro, as a thank you.

There is no subsequent contact between cord donors and recipients who then benefit.

The NHS cord blood bank collects in a further six hospitals Barnet General Hospital, Luton and Dunstable Hospital, Watford General Hospital, and Londons Northwick Park, St Georges and University College Hospitals.

Read the original here:
How new mums' umbilical cord blood can save lives as 'collectors' use it for stem cell transplants - Mirror.co.uk

Garo/Phanie/Science Photo Library

Biopsies can help track when a benign tumour turns malignant.

Databases worldwide are rapidly swelling with the sequences of thousands of cancer genomes. Now, some scientists are advocating that researchers shift their focus back in time: to study the DNA of tumours in their adolescence, before they commit to being cancerous.

At the American Association for Cancer Research (AACR) annual meeting in Washington DC, researchers gathered on 2 April to discuss the growing call to sequence the genomes of pre-cancerous lesions abnormal growths that sometimes progress into full-blown cancers. The results could help researchers to determine which tumours warrant treatment and could aid the development of therapies to block cancers on the path to malignancy.

It is a project that is now near the top of the cancer research wish list, says oncologist Elizabeth Jaffee of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University in Baltimore, Maryland. This is something that has really taken off throughout the cancer community, she says.

The idea could be one of the next 'big science' projects for cancer. The idea is to borrow some tactics such as coordination among scientists and sequencing centres from The Cancer Genome Atlas, one of the first and biggest cancer genome efforts, which characterized the genomes of 33 cancers using samples from more than 11,000 people.

But the new 'Pre-Cancer' Genome Atlas would also study cancers over time. It would ideally include multiple snapshots of the same tumour as it developed, in the hope that researchers will be able to determine what changes pushed it across a tipping point to become cancerous.

Individual laboratories have already embraced this concept. Pulmonologist Avrum Spira of Boston University in Massachusetts has been studying the origins of lung cancer by sequencing samples from people with pre-cancerous lesions in their airways. Such biopsy samples are typically taken every 6 or 12 months.

Lung cancer, he says, seemed a logical testing ground for the sequence-over-time approach. It is the most common cause of cancer death worldwide. The major reason: we almost always detect it late, he says, adding that as his team carried out the sequencing, it hit us that this could be a paradigm that applies to other cancer types.

Thomas Kensler, who studies cancer prevention at the University of Pittsburgh in Pennsylvania, points to recent advances in characterizing thyroid cancer that have led to genetic tests to distinguish which tumours warrant treatment. Not every lump in the thyroid is necessarily destined to be a cancer, he says.

At the AACR meeting, cancer researcher and physician Rafael Bejar of the University of California in San Diego presented his ideas for extending the model to include liquid tumours such as leukaemias. Normal blood is derived from many stem cells, and genetic sequencing can match blood cells to the stem cells from which they were derived. So if a blood test reveals that one lineage of stem cells is beginning to take over the population, it could be an early sign of cancer and subsequent monitoring could reveal if the disease takes hold.

But a coordinated effort, says Bejar, could boost the impact of these individual projects. Last September, advisers to the US Cancer Moonshot initiative an effort to double the pace of cancer research in five years included a pre-cancer genome project among the schemes they recommended for investment. And Spira says that the project was discussed at a US National Cancer Institute meeting in late March, and will be taken up again at a meeting in June.

What the community wants next, say advocates of the programme, is a firm financial commitment to take the project from concept to reality. Theres a lot of enthusiasm, Bejar says. People are moving forward.

Link:
Hunt for cancer 'tipping point' heats up - Nature.com

Breakthrough Therapy Designation is described on the FDA website as "a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s)." It was signed into law in 2012, with the first full approval of a breakthrough designation candidate being only one year later. As of March 30, 2017, FDA has granted breakthrough therapy designation to 170 of the 505 total requests, and eventually approved 55 breakthrough therapy designated products.

The concept makes sense. If a new drug that aims to treat serious and life-threatening conditions shows unprecedented effect in early clinical trials, patients should not have to wait to receive treatment. A group called Friends of Cancer Research worked with partners in advocacy, regulation, drug development, and bipartisan congressional champions to take breakthrough therapy designation from concept to an expedited FDA development program. This ensures patient access to revolutionary drugs is as quick and effective as possible. A drug that receives breakthrough therapy designation is eligible for all FDA fast track features, intensive FDA guidance on an efficient development program (as early as phase 1), and organizational commitment involving FDA senior project managers.

FDA bases its decision to grant breakthrough therapy designation on scientific support for clinical endpoint(s). Studies that demonstrate a drug's effect on a surrogate or intermediate clinical endpoint must be "adequate and well controlled" as required by the FD&C Act. Using surrogate or intermediate endpoints can save valuable time in the drug approval process. Consider an example of cancer patients. Rather than wait for a study to complete a potentially lengthy overall survival measurement, FDA may approve a drug based on evidence of tumor shrinkage, associated with a shorter measure such as progression-free survival, because it is considered reasonably likely to predict clinical benefit (and hence prolonged survival of patients).

This well written article about the drug development process addresses the process and is worth a quick read. A cancer drug development company will still need to conduct studies to confirm that tumor shrinkage actually predicts that patients will live longer, which is sometimes a phase 3 or even a phase 4 clinical trial. One common question often asked by StrongBio stock club members (send email to join, its free) is, "will a company have to wait to market a drug until trials assessing secondary endpoint data or confirmational long-term effects of drugs on a patient population are completed"? So the answer can be yes or it can be no. The industry currently anticipates that primary consideration for marketing approval by FDA is primary endpoint result(s). So it depends what the primary endpoint of the trial is predetermined to be with FDA, in an advanced declaration called a special protocol assessment. Though caution is warranted when predicting clinical trial result interpretation by FDA, it is clear that shorter endpoint measures such as progression free survival were specifically developed by scientists and clinicians (over many years with massive resource allocation) as reliable metrics for early approval.

As a biotechnology stock investor, one valuable tool for learning about what therapeutic candidates FDA might favor, is the Friends of Cancer Research list of FDA Breakthrough Therapy Designations. If you have not included this or Knect365 lists as part of your due diligence, please consider doing it now. These lists consist of many indications in medicine, not just cancer. Many, but not all, of the stocks on this list have performed well, and having FDA in a supportive role behind a drug candidate has proven to have boosted confidence in these stocks when reviewed in articles analyzing how they are priced by the Street. Since excitement surrounds the designation, an increased stock price can be used to generate funds for the company to begin early manufacturing initiatives. In this way investors help serve those in need of life-saving therapies by funding faster production in hopes for a future payoff. Everyone can win in this positive scenario.

Genentech [Roche Holdings, (OTCQX:RHHBY)], with 15 breakthrough therapy designations, is a leader in the breakthrough designation category, with several rare and specialty indications. But with its multiple players and large market cap, it's more difficult to measure an effect of a breakthrough therapy on stock price. Factors that an investor should consider when looking at the designation is the potential market compared to company market cap. So Immunomedic's (NASDAQ:IMMU) Sacituzumab Govitecan breakthrough therapy designation for triple negative breast cancer with a 6 billion dollar market and only 600 million dollar market cap might be seen as more attractive in contrast to RHHBY (market cap 216 billion) rituximab designation for pemphigus vulgaris, a rare autoimmune disease causing skin and mucosal membrane blisters, with estimated market in the low hundreds of millions. At the time (February 2016) IMMU reported its breakthrough therapy designation it was trading at about 2 dollars per share, and is now about 6.50 about a year later (after several futile attempts by short-sellers to discredit the company ultimately at breast cancer victim's expense), compared to RHHBY, which has moved from about 31 dollars per share since its Mar 21, 2017 announcement to 32 dollars this week. It is extremely unlikely rituximab will drive RHHBY to 105 dollars one year from now to match IMMU's market performance of Sacituzumab Govitecan. However, one should never underestimate the ability of big pharma to gain an expedited product approval and then have that product used for other indications "off label" when other treatments fail. For instance, rituximab has implications in treating Lupus, with an increasing 3.5 billion dollar industry by 2025. For the purpose of breakthrough therapy designation affecting stock price, StrongBio will focus on a few publicly traded (Novimmune, Rebiotix, and Rhythm are interesting but privately held companies) small market cap representatives in this article in order to make some conclusions, referring to larger market cap companies as a point of reference.

Like IMMU, Adaptimmune (NASDAQ:ADAP) received breakthrough therapy status, but for affinity enhanced T-cell therapy targeting NY-ESO in synovial sarcoma in February 2016. With a market cap of under 400 million and a potential market in the low hundreds of millions per year in synovial (and other off label or future indication) sarcomas, this is certainly an attractive investment to StrongBio if weakness in market price should occur. Some investors regard ADAP as some of the best cancer work being done right now, and recommends it as a good investment in the 200 billion dollar immunotherapy cancer space. Having raised some funds recently and having strong partners, the stock has decreased in value from about 7 dollars per share to about 5.50, but has some recent positive momentum after raising funds in an offering at just over 4 per share. It was first covered by StrongBio at 4 dollars earlier this year. IMMU and ADAP have both shown to be somewhat volatile following breakthrough therapy designation, warranting scrutiny of timing before entering a long position based upon breakthrough designation.

Another stock, like ADAP, that has trended down since its breakthrough designation by FDA is Trevena (NASDAQ:TRVN). TRVN has dropped over 50% since designation, February 22, 2016, shooting from 7 dollars per share to about 9 dollars per share, but is now trading at 3.65 per share one year later. TRVN's oliceridine, an acute pain control drug for treating moderate to severe post-bunionectomy or abdominoplasty, even met its phase 3 trial endpoints for pain control. But as this article summarizes well, may be seen as too expensive compared to morphine and other pain killers. This article by the Street makes a good case for TRVN in how oliceridine met pain control endpoints and potentially offers an advantage in a profile of side-effects including nausea, vomiting, and depressed breathing. However some of the side effects were not (yet) reported as statistically significant. With analyst price targets of 12 dollars and slew of legal class action threats that mimic the ones that IMMU had before its rapid price ascension, it is probably likely that once short sellers have covered TRVN will reach its targets. Certainly one to watch given this share weakness if one likes to use a contrarian approach. We know from StrongBio research done on the plastic surgery industry in previous articles that the industry is rapidly growing, and people don't seem to mind paying expensive prices. A more expensive but better pain killer may not be seen as a negative after all.

Kite Pharma (NASDAQ:KITE), market cap 1.8 billion, received FDA breakthrough therapy designation in December, 2015 for its refractory aggressive non Hodgkin lymphoma candidate KTE-C19. The cancer market is in the 100 billion range, so this stock should be on just about every biotechnology enthusiast's radar. At that time KITE was trading at about 75 dollars per share after a ramp up from about 50 per share earlier that fall. The price of KITE settled back to about 40 to 50 per share from January 2016 to January 2017, only recently increasing to its current 78 dollar level. KTE-C19 is therapy in which a patient's T cells are genetically modified to express a chimeric antigen receptor targeting the CD19 maker, a protein expressed on the cell surface of B cell lymphomas and leukemia. Its breakthrough designation includes treatment of diffuse large B cell lymphoma, primary mediastinal B cell lymphoma, and transformed follicular lymphoma. Investors are optimistic due to early studies which have demonstrated 31% "curative" complete responses and remission in chemorefractory diffuse large B cell lymphoma patients after a single treatment. Analyst targets for KITE are at an average of 86 dollars per share. Timing is critical for a long position in this company, and as volatile as the share price has been over the last 2 years, anything is possible. Ironically, this stock has remained flat in spite of the volatility since breakthrough designation.

Juno pharmaceuticals (NASDAQ:JUNO) [breakthrough designation December 2016 for JCAR017 for treatment of relapsed/refractory aggressive large B-cell maladies], Novartis, (NYSE:NVS) [forPKC412 midostaurin for adults with FLT3+ AML and LEE011 combination with letrozole for treatment of HR+/HER2- advanced or metastatic breast cancer], and Bellicum pharmaceuticals (BLCM) [no breakthrough candidate] are also operating in this B cell cancer area, with emphasis being put on safety by limiting graft versus host risks of these robust anti-cancer therapies. Juno, with a 2.5 billion dollar market cap might be undervalued. Having recently discontinued development of its nicely active anti-cancer JCAR015 for ALL, due to safety issues, combined with its early FDA favor for JCAR017 plus immunosuppression regimen, and strong cash position of nearly 1 billion, one can make a good investment case on a further pullback. Immunosuppression drugs, cytokines, T-Cell, and stem cell therapies are all approaches designed to make these therapies less likely to attack healthy tissues. BLCM just raised money in an offering at 12 dollars per share, has a market cap of 330 million, and analysts average target at 27.50. StrongBio regards this option as potentially the best potential market to market cap ratio, should BLCM succeed in pulling down a share. Uniquely, BLCM technology involves modifying donor immune cells with a "kill switch" that is activated with administration of rimiducid. In an ongoing trial with 122 pediatric patients receiving partially matched donor stem cell transplants, five cases of uncontrolled graft versus host disease were resolved by the rimiducid-activated kill switch. Juno, Novartis, and Kite are good investment candidates with plenty of up-side, but the dominant market share will go to the company that best suits safety needs in graft versus host reaction. NVS is a giant with a monster market cap of 174 billion, making it more difficult to obtain a high return due to any sole candidate. So in this case perhaps riding the wing of an FDA breakthrough therapy status candidate could provide the best investment opportunity, via BLCM acquisition or stand-alone data. This creates a new category of investment candidates and fits the StrongBio contrarian outlook.

Exelixis Inc. (NASDAQ:EXEL), with a 6 billion market cap, was granted breakthrough therapy designation by FDA for renal cell carcinoma with one prior therapy. As a more mature representative of the speculative designation class, its chart reflects a little more of a steady classic upward stair than a volatile up and down nausea inducer. Since the launch of its kidney drug, Cabometyx, has grown to about 27% of the 1 billion dollar market in renal cancer. At the time of designation, it traded at about 9 dollars per share, and now trades at about 21 dollars per share 18 months later. Having made efforts to decrease its debt, and expand its pipeline, and make international partners including Takeda Pharmaceuticals in Japan, the company is stabilizing and poised for stock growth, even with its fairly large market cap. The value of stability and income can never be underappreciated, nor can a nice stepwise ascension in stock price over 100% per year.

uniQure N.V. (NASDAQ:QURE), a Dutch gene therapy company, received breakthrough therapy designation for AMT-060, its investigatory gene therapy in patients with severe hemophilia B. With a market cap of only 145 million dollars, its stock price is relatively flat since the announcement Jan 30, 2017. QURE has received regulatory approval in the European Union and carries a relatively low valuation compared to its peers, including Bluebird bio (NASDAQ:BLUE), Avalanche (AAVL), and most recently Spark Therapeutics (NASDAQ:ONCE). Briefly, gene therapy offers curative potential by inserting a gene encoding the expression of a therapeutic protein with a single administration. When a gene encoding a blood clotting protein is missing or mutated in hemophilia B patients, QURE technology introduces a copy of the proper gene to restore the presence of the clotting factor, preventing uncontrolled bleeding. Given its small market cap and high reward to risk ratio in this 10 billion full market for hemophilia, QURE could have some potential upward volatility in its future.

Tonix Pharmaceuticals (NASDAQ:TNXP) is a unique company because it received breakthrough therapy designation in December 2016 for its post-traumatic stress disorder drug candidate, TNX-02 SL. TNX-102 SL is a protective eutectic oral formulation of cyclobenzaprine that allows for a rapid systemic exposure and increased bioavailability through transmucosal delivery to modulate sleeping cycles. Scientific mechanism of action is to block serotonin receptor 2A, associated with an increase in restorative slow wave sleep and a decrease in waking after sleep onset. With a market cap around only 18 million, there would seem to be a lot of upside to this reward to risk analysis. Tonix has advanced its candidate TNX-02 SL to phase 3. But TNXP is also plagued by typical early stage biotechnology company challenges, including having recently reverse split its stock to stay listed on the Nasdaq exchange, and recently raised 8 million in capital in an offering, providing the company with approximately 30 million in operating capital. Recently TNXP enrolled its first military related post-traumatic stress disorder patient in its study. Because this stock has not made much of a move yet, some potential for upward volatility remains for TNXP stock. Because there is a likelihood of another raise of cash, StrongBio would advise caution in investing heavily in spite of the wonderful cause.

The full scope of breakthrough designation grants is beyond the scope of a Seeking Alpha article, but demonstrated is the main point that FDA breakthrough therapy designation lists yield fascinating investment candidates. Remember there are no sure things in the stock market, and that investing in biotechnology includes a lot of variability in results, risks, and volatility. Investment strategies previously published by StrongBio best include timing entries of positions, making good critical selections of key growth, and optimizing foreseeable market favor. One way to maximize the chances of an optimal result for market favor is to diversify the portfolio with companies that have obtained FDA breakthrough therapy designation, especially when perceived as undervalued. Though there are no guarantees that the market is going to reward investors short term, in the long run it appears that most breakthrough designation candidates meet with success eventually. The charts also caution that volatility may be associated with these picks. StrongBio recommends putting candidates with FDA breakthrough therapy designation on the watch list and hedge in on pullbacks.

Disclosure: I am/we are long IMMU.

I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

Additional disclosure: Secondary tickers include RHHBY, IMMU, ADAP, TRVN, KITE, BLCM, EXEL, JUNO, QURE, BLUE, AAVL, ONCE, TNXP but were not listed as options

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Impact Of FDA Breakthrough Therapy Designation Speculative Biotechnology Stock Performance - Seeking Alpha

The president of DSM Food Specialties, Ilona Haaijer, has told FoodBev that shes really excited to be able to offer laboratory and scale-up facilities as part of its new biotechnology centre in the Netherlands.

The company unveiled the Rosalind Franklin Biotechnology Center on its Delft campus earlier, where more than 400 scientists will advance the companys research into food enzymes, cultures, bio-preservatives and taste ingredients for the global food industry.

Alongside significant investments in robotics and automation, the centre and the surrounding campus includes space for start-ups to explore and scale up their concepts in partnership with DSM Food Specialties.

At the opening: Alex Clere

There was a general buzz, a sense of excitement at the unveiling of DSMs imposing glass biotechnology centre this morning. DSMs scientists had already moved in, keen to give visitors an impression of the new equipment some the result of millions of euros worth of investment and collaborative spaces in action.

Ahead of the unveiling ceremony, DSM Food Specialties president Ilona Haaijer told me which of the companys products she thought were particularly pertinent, given the state of the food industry at the moment.

Its MaxiLact product, which removes lactose from a product while delivering additional sugar reductions, was flying, she said. And the Preventase proprietary enzyme allows brands to limit the amount of acrylamide in bakery items amid widespread concern across Europe.

This new centre, a major achievement for DSM, will help the Food Specialties business continue to meet the industrys biggest trends and satisfy changes to consumer preference.

The Rosalind Franklin Biotechnology Center is part of DSMs network of more than 30 laboratories in ten countries. According to Gerhard Wagner, the director of DSMs Biotechnology Center, the company has sought to align itself with local technology hubs like Boston, Massachusetts and put down roots close to its markets.

Haaijer also noted that the world was becoming an increasingly volatile, uncertain, complex and ambiguous (VUCA) place, which made the prediction of future trends difficult.

The process was no longer as linear as it had once been, becoming an art, not a science.

But in that challenge was the opportunity for DSM to increase its participation with external stakeholders, like Delft University of Technology and Corbion.

The biotechnology centre in Delft has also been designed with the help of DSMs scientists, and includes features and open spaces deliberately intended to encourage cooperation and collaboration between employees.

Haaijer claimed that it was more and more important to open up with chief operating officer Cindy Gerhardt adding that this was the only way companies can be early to market with a product.

The Rosalind Franklin Biotechnology Center will play a crucial role in that strategy.

Originally posted here:
DSM 'excited' by biotechnology opportunites, president says ... - FoodBev.com

Nasdaq

Cellect Biotechnology Gets European Patent (APOP) Investopedia secured a European patent covering a method of treatment from the European Patent Office. The patent covers cell-based therapeutics of Cellect's technology and method that have the potential to treat diseases like diabetes, graft-versus-host disease, ... BRIEF-Cellect Biotechnology receives formal notice of intention to grant for a patent from European patent officeReuters Cellect Biotechnology (APOP) Granted European Patents Protecting ...StreetInsider.com Cellect Receives Notice of Intention to Grant from European Patent ...P&T Community all 9 news articles »

Original post:
Cellect Biotechnology Gets European Patent (APOP) - Investopedia

by Zacks Equity Research Published on April 04, 2017

ANTH APOP

Cellect Biotechnology Ltd. (APOP - Free Report) was a big mover last session, as the company saw its shares rise over 10% on the day. The move came after the company announced that it has received a formal notice of Intention to Grant for a patent covering a key method of treatment from the European Patent Office. This also led to far more shares changing hands than in a normal session. This breaks the recent trend of the company, as the stock is now trading above the volatile price range of $5.94 to $10.90 in the past one-month time frame.

None of the estimates for this stock were revised in the last 30 days and the Zacks Consensus Estimate also remained unchanged. Yesterdays price action is encouraging though, so make sure to keep a close watch on this firm in the near future.

Currently, Cellect Biotechnology carries a Zacks Rank #3 (Hold).

A better-ranked stock in the same industry is Anthera Pharmaceuticals, Inc. (ANTH - Free Report) , sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of todays Zacks #1 Rank stocks here.

Is APOP going up? Or down? Predict to see what others think: Up or Down

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Cellect Biotechnology (APOP) Jumps: Stock Moves 10.5% Higher - Zacks.com

(Photo: http://mma.prnewswire.com/media/485639/VSY.jpg )

VSY Biotechnology considers it important to note that this is a ruling by the German Court of First Instance. VSY Biotechnology has the right to and will appeal this judgement with the Higher District Court and if necessary with the Federal Supreme Court in Germany. It is expected that a final ruling on the infringement may take several years and German Court's ruling is only effective in Germany but not in all over the world.

VSY Biotechnology B.V. reserves its right to seek material and moral indemnity for all direct and indirect damages of VSY Biotechnology on basis of unfair competition and defamation due to incomplete press release of Carl Zeiss dated March 27, 2017. Further VSY Biotechnology will ask for all damages they may suffer from the decision of the First German Court in case of District Court or Federal Court rule in favor of VSY Biotechnology.

Additionally, VSY Biotechnology applied for invalidation of Zeiss Patent EP 2 377 493 B1 before EPO with the claim of Zeiss Patent has lack of novelty, lack of inventive step, therefore unpatentable.

VSY filed opposition against Zeiss patent

VSY Biotechnology B. V. (VSY) has, amongst others, filed an opposition against Carl Zeiss Meditec A.G.'s (Zeiss) European patent EP 2 377 493 B1 "Method for manufacturing aphakic intraocular lens" (EP'493) with the European Patent Office (EPO) on May 6, 2016. Zeiss acquired EP'493 from the German IP advisers IP Strategists GmbH who acquired the patent from the Japanese company Menicon Co..VSY is of the opinion that EP'493 does not fulfil the requirements of patentability as it lacks novelty and inventive step, is insufficiently disclosed and includes extension of subject matter.

The patent regards Trifocal intraocular lenses. Trifocal lenses of Zeiss are AT LISA tri and the AT LISA tri toric.

The opposition is still pending.

All details of the opposition can be found on: https://register.epo.org/application?number=EP09837427&lng=de&tab=doclist

About VSY Biotechnology BV

VSY Biotechnology is one of the leading companies in Industry of ophthalmology focusing on cataract surgery, producing premium intra ocular lenses and viscoelastics. For more information, please visit company website. http://www.vsybiotechnology.com.

SOURCE VSY Biotechnology

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Patent Case of Carl Zeiss Meditec AG and VSY Biotechnology B.V. - PR Newswire (press release)

04 Apr 2017 --- DSM has opened a new state-of-the-art biotechnology facility at its site in Delft, the Netherlands that will expand its research and development capabilities in fermentation and biotechnology for food applications. The site is really focused on biotech and fermentation, says Ilona Haaijer, President of DSM Food Specialties. The new Biotechnology Center is a further step in the development of the site, where DSM Food Specialties has its global headquarters. The completion of this new Biotechnology Center is part of a 100 million investment program by DSM to scale up R&D in the Netherlands since 2013.

The new center brings together over 400 highly-skilled scientists from around the world who conduct breakthrough research in advanced fermentation technology, processing, genetics, analytics and food technology. Haaijer tells FoodIngredientsFirst: Technology plays a key role in finding solutions. We need to find a way to feed all the people and need to find a way to do it in a healthy way. We believe passionately in our purpose of enabling better food for everyone. We can apply our science-based competences and creativity to really unlock value for customers to create new innovations.

Click to EnlargeOne example of a breakthrough innovation is DSMs development of fermented steviol glycosides the reduced-calorie, sweet-tasting molecules in the stevia plant as an answer to the growing global demand for sugar reduced food and beverages. DSMs fermentation know-how helps meet this global growing demand for steviol glycosides of a high purity and reliable quality that are sustainably produced. Another breakthrough innovation is PreventASe, an enzyme that reduces acrylamide levels in baked goods, says Haaijer.

DSM has also invested together with other industry players in a state-of-the-art biotech fermentation pilot plant on the Delft site. The new center makes use of the latest advances in laboratory robotics and automation to expand R&D and food application development. Its location at the heart of the Biotech Campus Delft allows DSM to rapidly scale up promising food applications for customer validation and commercial roll-out.

In addition, with the current infrastructure, DSM can facilitate start-up or small companies with their production, making sure that innovative ideas reach the market. DSM is part of a food hub, our collaboration is with TU Delft, the city of Delft, and many academic institutions. We have science, scale up facilities and more lab facilities here, so we can host start-up and small companies, offering access to science and lab facilities, says Haaijer.

Click to EnlargeFeike Sijbesma, CEO/Chairman of the DSM Managing Board, commented: DSMs new Biotechnology Center is where our scientists create solutions for societal challenges such as the need to provide all people globally with nutritious food, as well as enabling the transformation from a fossil-based to a bio-renewable-based society. DSM Biotechnology Center facilitates these needs, in an innovative environment and at an historic location in Delft where we build nearly 150 years of scientific, academic and commercial activities.

The building itself has sustainable features with 3000m2 of glass panes and a glass roof of 22x9 meters allow ample daylight into the building, making it very transparent and light. A Dutch climate faade removes hot air from behind the glass panels, and is used to heat cold air coming in from outside the building, thus reducing energy consumption. Haaijer adds; What is interesting about this building, is the way it has been set up. It is a sustainably designed building, and each floor has its own competence. The flow of work is easy, and people from all research areas can find each other easily.

Click to EnlargeThis was also very clear during the tour through the building. Each floor is especially designed for its purpose and also focused on automation, relieving the labor intense load on the employees. One floor is designed for FIND, where initial screening of their huge bacterial strain library takes place, whereas another floor is especially designed for MAKE, where the bioprocess development takes place. Our core technologies help us predict the effect of enzymes and microorganisms so we can select the perfect fermentation organisms and help us quantify bioprocess options and scale production sizes before transferring to factories, says Gerhard Wagner, Director of the DSM Biotechnology Center. On the ground floor, the APPLY of the ingredient or enzyme is investigated, characterizing the ingredients up to even the atom level using state-of-the-art Nuclear Magnetic Resonance technology.

DSMs Biotechnology Center will be named the Rosalind Franklin Biotechnology Center in honor of pioneering scientist Rosalind Franklin (1920-1958), whose extraordinary work during a tragically short life and career significantly contributed to our understanding of the structure of DNA, effectively creating the basis for modern biotechnology. By honoring Rosalind Franklin, DSM pays tribute to all female heroes of science.

By Maartje Geraedts in Delft

Food Ingredients News

04 Apr 2017 --- Sugar remains the key ingredient delivering the sweetness and great taste that consumers are looking for, specifically in the chocolate and confectionery sectors. The quest to combine taste and health is driving NPD, as the industry faces the challenge of balancing public demand to reduce added sugars and create indulgent experiences, while at the same time presenting clean label products.

Business News

04 Apr 2017 --- The Masan Group Corporation has revealed how global investment firm KKR has begun a definitive agreement to invest US$250 million in Masan Group and in its branded meat platform, Masan Nutri-Science.

Business News

04 Apr 2017 --- British multinational consumer goods company Reckitt Benckiser is considering selling off its food division at an estimated US$2 billion as it prepares to acquire infant formula maker Mead Johnson Nutrition.

Food Ingredients News

04 Apr 2017 --- As part of Brexit negotiations, the UK governments Great Repeal Bill will end the supremacy of EU law in Britain, an aspect at the very core of the UKs motivation for leaving the EU.

Business News

04 Apr 2017 --- CP Kelco have announced the completion of new production capabilities in its Okmulgee, Oklahoma plant for manufacturing KELCOGEL gellan gum. This expansion of gellan gum production capacity enables the company to respond to growing market demand for this high-performance product line, used in a wide range of food, beverage and other applications.

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DSM Expands RD Capabilities for Food Applications With ... - FoodIngredientsFirst

ALACHUA, Fla., April 3, 2017 /PRNewswire/ --Sid Martin Biotechnology Institute (SMBI), the leading biotechnology incubator at the University of Florida, has been awarded the Randall M. Whaley Incubator of the Year award for 2017, the highest award given by the International Business Innovation Association (InBIA). InBIA is the world's leading organization for advancing business incubation, acceleration and entrepreneurship. SMBI was named Incubator of the Year among more than 7,500 incubators worldwide. The annual award, sponsored by the Friends of the University Science Center in Philadelphia, recognizes the top global business incubation program and includes a cash prize.

The award was presented on March 28th at the InBIA's 31st Annual International Conference on Business Incubation. Accepting the award for SMBI were Mark S. Long, Director, and Merrie Shaw, Assistant Director. SMBI also received another award, the 2017 Technology/Science Entrepreneurship Center Program.

David L. Day, Assistant Vice President for Technology Transfer at the University of Florida, said, "We are honored for the Institute to be recognized as the best in the world incubator. It is a tribute to our staff and their outstanding efforts helping startups grow great innovations and new solutions into successful businesses that will make the world a better place."

SMBI has a biotechnology focus, and over the past 21 years has served more than 100 startup companies in biotechnology, biomedicine and bioagriculture. The Institute has created more than 2,200 high-tech jobs since its inception, and SMBI resident companies have accumulated over $1.62B in capital and M&A activity. There is a 93% survival rate for companies that entered the SMBI program since March of 2003, and an overall 78% survival rate for all companies served over the past 21 years.

Since becoming Director of SMBI in January 2016, Long has overseen the admission of 13 new companies, and the graduation of three companies. "We continue to see the growth of North Central Florida as a biotech hub," said Long. "As part of the University of Florida's Research Foundation, we are able to offer new biotechnology startups a tremendous wealth of resources, advisement and equipment. We are proud to be recognized by our peers as the top incubation program in the world."

About Sid Martin Biotechnology Institute at the University of Florida

The Sid Martin Biotechnology Institute (SMBI) is the leading biotechnology incubator headquartered at the University of Florida in Alachua, Florida at Progress Park. SMBI has been honored with national and international awards for incubator excellence and achievements in technology commercialization, funding access, job creation and technology-based economic development. It is dedicated to mentoring and accelerating the growth of innovative early-stage bioscience and biotechnology companies, and supporting the economic growth of the North Central Florida region. For more information, visit sidmartinbio.org.

Contact:Merrie Shaw, Assistant Director, Sid Martin Biotechnology Institute, 386-462-0880, mashaw@ufl.edu, sidmartinbio.org

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University of Florida/Sid Martin Biotechnology Institute Receives ... - PR Newswire (press release)

Heres some good news: Medical marijuana is helping people with arthritis improve their quality of life.

Most of us know someone an aunt, uncle or grandmother suffering from arthritis. It is one of the most common health ailments in the world, with more than 50 millionpeople affected in the U.S. alone.

The term arthritis is actually a category that includes over 100 conditions and diseases affecting joints and surrounding tissue. Symptoms of pain, stiffness and swelling aching joints are common. Arthritis can seem inescapable and changes peoples quality of life. There is no known cure.

Despite anecdotal evidence about efficacy of marijuana for arthritis, physicians simply dont know enough about it to engage their patients about it as a treatment option. In one study, 70 percent of physicians said they would not know how to discuss possible interactions with other meds or suggest dose.

That is a great shame since cannabis has a better safety profile than the NSAIDS, steroids and opiates that are often employed to reduce arthritis discomfort but come with increased risk of heart attack, stroke, weakening of bones and addiction. Even if patients were able to use cannabis as a complementary therapy, they could very potentially cut back on the use of harder, more dangerous meds.

Its no surprise that cannabis could offer arthritis sufferers relief. After all, cannabis is known to be as much as 20 times more effective than aspirin at reducing inflammation and can be an effective sleep aid. Some research certainly supports those decisions.

An Israeli study found that 90 percent of medical marijuana patients stayed on their medicine regimen and most reported reduced pain and function. Researchers at the University of Nottingham noted that targeting cannabinoid receptors with medical marijuana products may help bring pain relief to knee joint pain associated with osteoarthritis.

The first Health Canada approved cannabis clinical trial studying arthritis began in 2016. The CAPRI Trial (Cannabinoid Profile Investigation of Vaporized Cannabis in Patients with Osteoarthritis of the Knee) will compare the effects of different ratios of THC and CBD as well as the short term safety of vaporized cannabis. Results have not yet been published.

Similar to other ailments, a gap exists between physician knowledge base about cannabis and patient interest. Some patients and physicians will wait until there is irrefutable evidence before trying cannabis as an alternative therapy. Others will not wait for more information and seek to improve their quality of life with cannabis now.

What we do know is that as more states come online with regulated medical marijuana, more patients will have an alternative to consider, and having options is good news.

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There's No Known Cure For Arthritis, But Marijuana Works Wonders - The Fresh Toast

April 4, 2017 10:36 AM By Dr. BrianMcDonough

(Credit: Thinkstock)

KYWs Medical Reports Sponsored By Independence Blue Cross

PHILADELPHIA (CBS) There is new research in the journal Arthritis Care that obesity could be linked to arthritis. This is the most recent of several studies that have looked into this.

In a study that looked at patients as far back as World War II and compared results, it was found that young people are reporting arthritis at an earlier age.

This study, based in Toronto, Canada, found that the problem got worse with added weight.

Severely obese people were 2.5 times more likely to report arthritis than people with normal weight.

Reviewing data across successive 18-year spans over a 70-year time frame, the scientists compared how prevalent arthritis was in succeeding generations and found that, at the same ages, those in each successive generation were more likely to report arthritis than their predecessors.

The researchers, along with many others around the world, are looking at reasons behind the link between obesity and joint issues.

Dr. Brian McDonough has been medical editor at KYW Newsradio for more than a quarter-century (since 1987)! Brian McDonough has been honored as Family Physician of the Year by the Delaware Academy of Family Physicians, and is a Sir William Osler...

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Arthritis Could Be Linked To Obesity, Study Finds - CBS Philly

DETROIT (TNS) Orthopedic surgeon Dr. Matthew Brewster had long sought a better treatment option for his younger, still-active patients suffering from arthritic joint pain in their big toe.

The gold standard for moderate to severe big-toe arthritis a fusion of the bones could relieve their pain but permanently rob them of mobility in the toe, limiting their ability to partake in athletic activities such as jogging and, for women, wearing heels.

I didnt like fusing 55-year-old womens toes that want to run and wear heels, said Brewster, who practices at Associated Orthopedists of Detroit and is affiliated with Beaumont Hospital in Grosse Pointe, Mich.

So when the U.S. Food and Drug Administration last July approved the first synthetic cartilage-like implant as a treatment for big-toe arthritis, he signed up. Brewster performed his first procedure with the Cartiva implant that month, helping a 62-year-old Clinton Township, Mich., woman regain the ability to wear shoes without pain and even go running.

She became only the second U.S. patient to receive the implant, which has been available in Europe for more than a decade. The first procedure was in Rochester, N.Y.

Brewster, the procedures second U.S. doctor, has since successfully treated 13 patients with the implant. All of them were relieved of their pain and kept about half of their pre-arthritis joint mobility, he said.

Although the implant material is only currently approved in the U.S. for the big toe, it has been successfully used to treat arthritic thumbs and knees in Canada and Europe and offers hope for the millions of arthritis sufferers who wish to remain active and avoid joint replacements that steal their mobility and require extensive surgeries once the devices wear out.

An estimated 2.7 million middle-age people in the country right now have big-toe arthritis.

Brewsters patients health insurance agreed to cover the Cartiva implant and procedure costs, which are said to be slightly higher than a standard bone fusion.

When he approached me with this, it sounded too good to be true its not, said Karen Schumann, 51 of Chesterfield Township, Mich., Brewsters most recent patient, whose big-toe procedure was Feb. 22.

In an interview last week, Schumann recalled how her left toe had been in increasing pain for nearly 10 years and that she could no longer bend it. Now more than three weeks after the operation, her pain level is zero, and she once again can go on long walks for exercise and go up and down stairs.

She hopes to have the same procedure done later this year on her right foot.

I am so glad I had it done. You never realize how much you use the big toe until it hurts, Schumann said.

Headquartered outside Atlanta with 25 employees, Cartiva developed its Synthetic Cartilage Implant through research that originated out of Georgia Tech. The device is made of polyvinyl alcohol hydrogel, the same material as contact lenses, but is much thicker and the result of a patented process that makes the material incredibly tough yet with a water content comparable to healthy cartilage. Each implant is expected to last many years, although the material is still too new to make precise estimates.

Cartilage is a smooth, connective tissue that has a limited ability to repair itself if damaged. Researchers have been trying for decades to find a way to replace it. Degenerative arthritis occurs when cartilage gets worn away and bones then rub against each other.

Synthetic cartilage or injectable cartilage or some type of implantable cartilage is definitely the Holy Grail of orthopedics, said Dr. Todd Irwin, a foot and ankle orthopedic surgeon at the University of Michigan Health System who has done two Cartiva implant procedures.

I think this is very promising, Irwin said, but added, I think calling it synthetic cartilage is personally a little bit of a stretch. To me, functionally its more of a bumper between the bones.

Cartiva first introduced its hydrogel implant in Europe in 2002. But gaining FDA approval entailed more clinical trials and didnt happen until last July.

Big-toe arthritis, known as hallux rigidus, is the most common arthritic condition in the foot and said to affect 1 in 40 people older than 50, or roughly 2.7 million people in the U.S. Doctors say the problem can arise from genetics, past injuries or repeated stress from work occupations such as flooring installation.

Yet only about 100,000 Americans each year the majority of them female get surgical treatment for the condition, through fusions or typically metal joint implants. Those with less severe arthritis can find relief through a cheilectomy, which involves cleaning out the joint and removing bone spurs, although that procedure currently rules out getting a Cartiva implant later on.

Doctors say the biggest problems with traditional implants for the big toe are the relatively high complication rates and how they often dont last beyond seven years.

The Cartiva cartilage works like a bumper over the joints and is inserted into the base of the big-toe through a drilled hole.

Brewster said the procedure is relatively simple and takes him about 25 minutes. He considers it easier to perform than a traditional joint fusion of the toe, which takes more than an hour and involves scraping out cartilage, packing in a cadaver bone graft, then screwing two bones together with a metal plate.

Patients are sedated during the procedure and afterward can actually walk out of the clinic. For two weeks they are asked to wear a post-operative shoe, like a hard sandal. After that they can return to regular activities.

A small peer-reviewed study of 27 Cartiva patients in Canada and the United Kingdom found that five years after the implant, toe functionality had improved significantly in nearly everyone compared to before their procedure, the pain was significantly reduced and the synthetic cartilage was in good shape.

A full 96 percent of the patients said they would undergo the procedure again.

Rosalynn Demers, 62, of Clinton Township was the first Michigan patient to receive the Cartiva implant. She had been enduring progressively worse big-toe pain for about a year and could no longer wear most shoes because of pain.

I thought it was a bunion, but it was arthritis. It was a gradual thing and then (the pain) just became ridiculous, she said. I thought I as going to give all my shoes away, thinking that Id never fit into them again.

She had planned to get a fusion, even though she knew the procedure would bring an end to her running hobby. Then she learned about the new FDA-approved synthetic cartilage option from her husband, Dr. Mike Demers, an orthopedic surgeon who is a colleague of Brewsters.

In late July, Demers became the second person in the country to get the procedure. It was a success. Not only is she back to wearing almost all of her shoes, but she returned to running and even raced in the Detroit Turkey Trot 5K in November.

I couldnt believe I ran the whole thing, she said. It wasnt fast, but I ran it. So I thought that was pretty incredible.

Schumann, the Chesterfield Township woman who just had the procedure, recalled how Brewster demonstrated the new pain-free range of motion in her toe during a check-up appointment. Prior to the operation, a sudden movement like that would have caused searing pain.

All of the sudden, he bends my toe all the way down and Im like, What! Schumann said. He says, Does that hurt? and I go, No you just scared me. My toe has not been bent like that in years.

Link:
'Synthetic' cartilage is now an option for big-toe arthritis sufferers - La Crosse Tribune

Home Anti-Aging Arthritis Arthritis mutilans: Symptoms, causes, diagnosis, and treatment

Arthritis is a common term used to describe disorders that affect the joints, but we dont often hear about arthritis mutilans (AM). It is a severe but rare form of arthritis that attacks bone and cartilage in the joints.

People who suffer from arthritis mutilans usually face deformation in the joints of the hands and feet. The condition gets its name from its mutilating potential. It is a type of psoriatic arthritis that destroys the joints and can lead to the shortening of affected fingers and toes. Less than five percent of people who suffer from psoriatic arthritis (PsA) develop arthritis mutilans, but it is often confused with rheumatoid arthritis since RA can also cause joint deformity. Some doctors refer to arthritis mutilans as chronic absorptive arthritis because it causes bone resorption.

While arthritis mutilans impacts five percent of people with psoriatic arthritis, it affects about 4.4 percent of those who suffer from rheumatoid arthritis (RA). Psoriatic arthritis is a form of arthritis that develops in people who have psoriasis, which is a condition that is characterized by patches of red skin that are topped with silvery scales. Arthritis mutilans is one of the most severe types of PsA.

Back in 2003, the New England Journal of Medicine issued a report involving a 94-year-old woman who developed RA early in life. She only sought treatment in her 60s and imaging showed severe bone resorption in her hands and wrists as well as bone tissue collapse. The woman presented with something called telescoping fingers, a condition that occurs when soft tissues cant hold the fingers up and instead end up together in a heap. Severe deformities tend to appear in RA patients when they are not treated properly.

Just what causes arthritis mutilans continues to be a source of investigation. What we do know is that both psoriatic arthritis and rheumatoid arthritis can progress to arthritis mutilans. RA is a chronic and debilitating autoimmune disease that creates inflammation throughout the body, including the joints. PsA is also an autoimmune disease.

With arthritis mutilans, the bone and cartilage of joints get destroyed and lead to bone resorption. Unfortunately, bone tissue rebuilding doesnt happen, so people are left with soft tissues and therefore the bones collapse.

Arthritis mutilans symptoms can be life altering. The main sign of AM is severe bone tissue destruction, which leads to permanent joint deformity. This means that the sufferer is unable to move the joint, making day-to-day tasks extremely difficult. The condition tends to progress and may lead to telescoping fingers and toes, as previously described. There are cases where the bones fuse togetherwhen this occurs, joint function is lost. The fusion is called ankylosis.

Sadly, there are some sufferers who experience a condition known as glass opera hand. In these situations, the fingers are pulled out of shape as a consequence of severe destruction and bone absorption.

Normally AM is diagnosed through physical examination, blood work, and evidence of deformities detected in X-rays or MRIs.

As it turns out, enthesitis, which is irritability of the soft tissue, can help differentiate AMs parent condition psoriatic arthritis from rheumatoid arthritis. Doctors have come to realize that bone edema scores are high in people with arthritis mutilans. Bone marrow edema or lesions can be detected on MRI and are a cause of significant pain.

Abnormal stiffening of the joint can be an early sign for all types of arthritis, so more detailed examination of bone structure via tests like MRIs can be helpful in reaching an accurate diagnosis.

Early arthritis mutilans treatment is important if in fact, that is the diagnosis. Early, aggressive physical therapy has shown to delay the progression of the condition. For some people, it has meant that they are able to maintain the use of their hands longer. AM can also be treated with medications, including non-steroidal anti-inflammatories (NSAIDS) and corticosteroids.

A 2009 study showed some evidence that AM could be treated with medications called TNF inhibitors. The patients referred to in the study reported joint and skin improvements. Unfortunately, once a deformity occurs, there is little recourse. Sometimes, using a splint can stabilize joints and help reduce inflammation, but rheumatologists caution patients against using a splint for too long, as it can cause muscle weakness.

In recent years, some research has suggested that arthritis mutilans can be repaired with surgeries such as iliac bone graft procedures, which repairs damaged bones and joints, and arthrodesis, an operation that involves joint fusion.

Arthritis mutilans can be painful and disabling, but rheumatologists say that therapy and good care can help sufferers manage this rare form of psoriatic arthritis. How and why some people get AM may not be fully understood, but doctors have discovered that patients who focus on good overall health seem to manage the symptoms better than those who dont have a good diet, dont exercise, and arent able to manage stress. Hand therapy, occupational therapy, or physical therapy can be essential to AM patients. Although scientific evidence is limited, case evidence suggests that alternative therapies, including stretching, biofeedback, and acupuncture can be helpful.

Related: 11 best essential oils for arthritis: Control arthritis and inflammation

Related Reading:

Living with arthritis? Simple lifestyle and exercise tips to improve your joint health

Preventing arthritis in hand with exercise and natural remedies

http://www.psoriasis-ltd.com/arthritis-mutilans.php http://arthritis.ygoy.com/2010/08/06/what-is-arthritis-mutilans-symptoms-and-treatment/ http://www.medicalnewstoday.com/articles/316602.php

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Arthritis mutilans: Symptoms, causes, diagnosis, and treatment - Bel Marra Health

BBC News

Cookies on the BBC website BBC News Lady Gaga isn't suffering from arthritis, despite media outlets claiming that was the case last week. She appears on the cover of Arthritis magazine with a caption that reads: "I fought RA pain with my passion." But that quote isn't from Lady Gaga ... and more »

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Cookies on the BBC website - BBC News