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Archive for the ‘Regenerative Medicine’ Category

Another > $100M month for companies in the cell therapy space

Sunday, May 6th, 2012

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Last month we reported here on this blog that March was more than a $100M month for companies in the stem cell and cell-based regenerative medicine space in terms of monies raised.  

What we missed was a $15M grant from Cancer Prevention and Research Institute of Texas (CPRIT) for UK-based CellMedica.  This pumps last month's total to just under $140M.

This month, according to our sources, betters even March's better numbers by coming in at just over $170M though that is largely on the back of one large deal in Asia.  Here's how the numbers break down.

Allocure kicked off the month with a decent $25M Series B round from new syndicate member Lundbeckfond Ventures, as well as previous investors SV Life Sciences and Novo A/S.  Allocure is headed into phase 2 for acute kidney injury with an allogeneic mesenchymal stem cell therapeutic they currently call AC607.  


Little-known Canadian-based, Sernova then announced a $3.6M PIPE to fund continued development of its proprietary Cell Pouch System(TM), and, in particular, to fund the upcoming first-in-man clinical trial for patients with diabetes receiving an islet transplant.  The application to proceed with this trial is currently under review by Health Canada.


Next up was NeoStem closing a $6.8M public offering for "expanding" their contract manufacturing business, Progenitor Cell Therapy, and "enrolling the PreSERVE AMR-001 Phase 2 clinical trial for preserving heart function after a heart attack".  


The biggest deal of the month was a $65M convertible debt financing of China Cord Blood by none other than global powerhouse Kohlberg Kravis Roberts (KKR) through it KKR China Growth Fund L.P., a China-focused investment fund managed by KKR.  We believe this is deal is certainly an investment in the future of China's healthcare market potential but that it is bigger than that.  We believe a significant driver for this deal may likely have been the opportunity to consolidate this sector globally - to use a significant operation and 'war chest' to fund mergers and acquisitions on both the public and private cord blood banking sector worldwide.


The only classic first-round venture raise this month was a milestone-based $5M Series A by Bay City Capital into Phil Coelho's new company, SynGen, to fund his latest iteration of stem cell processing devices.


Forbion Capital then announced that it was leading a series D round, joined by fellow existing investors TVM Capital, Lumira Capital, Intersouth Partners, Caisse de depot et placement du Quebec, Morningside Group, and Aurora Funds, of $25M into Argos Therapeutics in order to kick them into their phase 3.  The hope here is that with some early phase 3 data they may be able to attract the elusive partner they couldn't land with a mere bucket of phase 2 data.


Innovacell landed the only European deal by announcing an 8.3M Euro (~$11M) investment by Buschier, Fides, HYBAG, and Uni Venture.  This will be used for the continued clinical development of its cell-therapy (ICES13) for the treatment of stress-urinary incontinence currently in a ph 3 study in several European countries.


ReNeuron announced a private placement also open to existing shareholders that brought in just under $10M (£6.1M) to support their phase 1 trial in stroke and other pre-clinical, clinical, and regulatory milestones. 


Finally, the Bio-Matrix Scientific Group, in an apparent ongoing quest to continuously reinvent itself, announced at month's end that they had formed a new subsidiary named Regen BioPharma and that they had raised $20M in a financing commitment from Southridge Partners II to purchase its common stock as required over the term of the agreement at a price set by an agreed formula.  This money is said to be dedicated to the acquisition of discovery-stage intellectual property and driving it through to phase 2 trials in an exercise of maximum value creation over a period they claim to be as short as 18-24 months.


..


So in the end, the month saw companies in the space raise just over $170M and even if you back out the stem cell banking deal its still over $100M for cell therapy companies.  


Over the 2 months, then, we've seen just over $311M raised through a variety of means by companies at every stage of maturity and for intended purposes ranging from acquisition, consolidation, early stage clinical development, and phase 3 testing.


--Lee


p.s. If you are aware of other deals in the sector this month, let us know and we'll update this accordingly.


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New Fund Established to Stimulate Regenerative Medicine Industry

Monday, April 30th, 2012

MONTREAL, QUEBEC--(Marketwire -04/30/12)- With a shared goal of supporting development projects that will boost innovation in the growing field of stem cells and biomaterials-based products, Pfizer Canada and the Centre for Commercialization of Regenerative Medicine (CCRM) have established the Pfizer-CCRM Innovation Fund to accelerate regenerative medicine (RM) technologies for drug screening and therapeutic applications. The announcement is being made at the first annual Till & McCulloch Meetings (April 30-May 2), Canada's premier stem cell meeting, jointly hosted by the Stem Cell Network and CCRM.

"CCRM was created on the premise that it would work with academia and industry on projects that will hopefully move RM technologies and innovations from the bench to the bedside," says Michael May, CEO of CCRM. "Canada is already a leader in this field and additional funding to advance novel research through early product development will only make us stronger. We're very pleased to be partnering with Pfizer Canada and appreciate their confidence in joining with us."

"Pfizer Canada is pleased to contribute to this new fund which will support important research here in Canada," explains Dr. Bernard Prigent, Vice-President and Medical Director, Pfizer Canada. "With the novel resources offered through CCRM's development capabilities, we hope to help advance the RM field in this country."

Pfizer Canada has contributed a total of $500,000 to the Pfizer-CCRM Innovation Fund and CCRM will contribute matching dollars to any approved projects undertaken in the duration of this fund.

About Centre for Commercialization of Regenerative Medicine (CCRM)

CCRM, a Canadian not-for-profit organization funded by the Government of Canada's Networks of Centres of Excellence program and six institutional partners, supports the development of technologies that accelerate the commercialization of stem cell- and biomaterials-based technologies and therapies. A network of academics, industry and entrepreneurs, CCRM translates scientific discoveries into marketable products for patients. CCRM launched in Toronto's Discovery District on June 14, 2011.

About Pfizer Canada

Pfizer Canada Inc. is the Canadian operation of Pfizer Inc., the world's leading biopharmaceutical company. Pfizer discovers, develops, manufactures and markets prescription medicines for humans and animals. Pfizer Inc. invests more than US$7 billion annually in R&D to discover and develop innovative life-saving and life-enhancing medicines in a wide range of therapeutic areas. Our diversified health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world's best-known consumer products. For more information, visit http://www.pfizer.ca

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Hospital Angeles Regenerative Medicine Institute PART 1 Tijuana Dr. Jesus Perez stem cells – Video

Wednesday, April 25th, 2012

23-04-2012 17:37 Warning! After spending $25000 on stem cells, the Regenerative Medicine Institute is IGNORING ME. They do not want to give me more stem cells unless I pay another $25000.00!!! THEY TOLD ME I ONLY NEEDED ONE TREATMENT!!!

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Hospital Angeles Regenerative Medicine Institute PART 3 Tijuana Stem Cells Dr. Jesus Perez – Video

Wednesday, April 25th, 2012

23-04-2012 22:03 Caution! Warning! After spending $25000 on stem cells, the Regenerative Medicine Institute is IGNORING ME. They do not want to give me more stem cells unless I pay another $25000.00!!! THEY TOLD ME I ONLY NEEDED ONE TREATMENT!!!

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ACT Announces Data and Safety Monitoring Board (DSMB) Approval to Increase RPE Dosage for Stargardt’s Disease Patients …

Wednesday, April 25th, 2012

MARLBOROUGH, Mass.--(BUSINESS WIRE)--

Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that the Data and Safety Monitoring Board (DSMB), an independent group of medical experts closely monitoring the Companys three ongoing clinical trials, have recently authorized the Company to move forward with enrollment and treatment of additional patients with Stargardts disease (SMD). In the U.S. SMD trial, ACT will screen and enroll patients for the second cohort, who, in keeping with trial protocol, will be injected with 100,000 retinal pigment epithelial (RPE) cells - as compared with the 50,000 cell dose used in the patients of the first cohort. The Company has also been approved to treat the final two patients to round out the initial dosing arm in its European trial. The use of pluripotent stem cells to derive RPE cells, and the use of the resulting RPE cells for treating a wide range of macular degenerative disorders, are covered by a robust patent portfolio owned by ACT, including a number of issued broad patents in key world markets.

DSMB authorization to move to the next higher dosage of cells in our U.S. clinical trial and complete the treatment of the first cohort of patient in our European trial represents yet another significant advancement for our clinical programs, commented Gary Rabin, chairman and CEO of ACT. We are pleased with the pace of progress and the continued finding of safety amongst the participants in both the U.S. and European trials. The results so far have been encouraging, and with our SMD programs having been granted orphan medicinal product designation in both the U.S. and Europe, we look forward to eventually reaching a stage at which we can further avail ourselves of all the regulatory and financial benefits this designation brings.

The three procedures comprising the first cohort of patients in the U.S. SMD trial were all conducted at University of California at Los Angeles (UCLA), by Steven Schwartz, M.D., Ahmanson Professor of Ophthalmology at the David Geffen School of Medicine at UCLA and retina division chief at UCLA's Jules Stein Eye Institute. The first procedure in the E.U. trial was conducted at Moorfields Eye Hospital in London, by a team of surgeons led by Professor James Bainbridge, consultant surgeon at Moorfields and Chair of Retinal Studies at University College London.

We are gratified to be moving to the next stage in both of our SMD trials, commented Robert Lanza, M.D., ACTs chief scientific officer. We remain very encouraged by the preliminary data in the first four SMD patients treated with the lowest dose of RPE cells at UCLA and Moorfields Eye Hospital. We are doubling the number of cells that will be transplanted in the next group of patients in the U.S. trial. We will be anxious to see if the higher dosage of RPE cells will impact visual function and photoreceptor rescue.

ACT is conducting three clinical trials in the U.S. and Europe using hESC-derived RPE cells to treat forms of macular degeneration. Each trial will enroll a total of 12 patients, with cohorts of three patients each in an ascending dosage format. These trials are prospective, open-label studies, designed to determine the safety and tolerability of hESC-derived RPE cells following sub-retinal transplantation into patients with dry-AMD or Stargardt's macular dystrophy (SMD) at 12 months, the studys primary endpoint. On January 20, 2012, the first SMD patient enrolled in the Companys U.K. clinical trial was treated at Moorfields Eye Hospital in London. The final patient of the first cohort in the companys SMD trial in the U.S. was treated on February 13, 2012.

Further information about patient eligibility for the dry AMD study and the concurrent study on SMD is also available on http://www.clinicaltrials.gov; ClinicalTrials.gov Identifiers: NCT01345006, NCT01469832 and NCT01344993.

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc., is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visit http://www.advancedcell.com.

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ACT Announces Third Dry AMD Patient Treated in Clinical Trial

Sunday, April 22nd, 2012

MARLBOROUGH, Mass.--(BUSINESS WIRE)--

Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today the dosing of the third patient in its Phase I/II trial for dry age-related macular degeneration (dry AMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs). The outpatient transplantation surgery was performed successfully, and the patient is recovering uneventfully.

Gary Rabin, chairman and CEO of ACT, commented, The completion of enrollment of the first cohort of patients in our dry AMD clinical trial is a significant step forward in our RPE clinical program. The first six patients in the U.S. trials have all been treated at UCLA, and as we have recently announced, the trials should soon expand to additional sites. As we have built our clinical team, we have been fortunate to have attracted the attention of some of the highest-caliber ophthalmologists and related institutions in the U.S. and Europe and recognize the huge value that their expertise provides us as we plan for the future of our therapeutic programs. With their guidance, we have also worked with the FDA to successfully expand the criteria of eligibility for patients to participate in our dry AMD trial.

The procedures at UCLA were all conducted by the team led by Steven Schwartz, M.D., Ahmanson Professor of Ophthalmology at the David Geffen School of Medicine at UCLA and retina division chief at UCLA's Jules Stein Eye Institute.

The six patients treated at UCLA to date have tolerated the surgical procedure well. commented Dr. Schwartz. There have been no complications in the procedure, nor any issues relating to the safety of the injected stem cell-derived RPE cells in any of the patients. We continue to regularly evaluate all patients in the trial, and while still preliminary, I am encouraged by the patients progress and the relative straightforwardness of the surgical procedure.

We are extremely pleased with the progress being made in all three of our clinical trials here in the U.S. and the U.K., commented Robert Lanza, M.D., ACTs chief scientific officer. The data we are reviewing seems to be pointing in the appropriate direction, With the treatment of the latest two dry AMD patients, we look forward to having more significant points of reference to understand the progress of the trial and consider the endpoint design for the next phase. Both Stargardts disease and dry AMD are progressive diseases that result vision loss and blindness due to the thinning of the layer of RPE cells in the patient's macula, the central portion of the retina responsible for central vision. We still have many patients left to treat during the course of these trials, but our team remains hopeful that stem cell-derived RPE cells may someday provide a new therapeutic approach for the treatment of many forms of macular degeneration. We hear from patients who suffer from these diseases on nearly a daily basis, and appreciate the huge responsibility we have to them.

ACT is conducting three clinical trials in the U.S. and Europe using hESC-derived RPE cells to treat forms of macular degeneration. Each trial will enroll a total of 12 patients, with cohorts of three patients each in an ascending dosage format. These trials are prospective, open-label studies, designed to determine the safety and tolerability of hESC-derived RPE cells following sub-retinal transplantation into patients with dry-AMD or Stargardt's macular dystrophy (SMD) at 12 months, the studys primary endpoint. Preliminary results relating to both early safety and biological function for the first two patients in the United States, one SMD patient and one dry AMD patient, were recently reported in The Lancet. On January 20, 2012, the first SMD patient to be enrolled in the Companys U.K. clinical trial was treated at Moorfields Eye Hospital in London. The final patient of the first cohort in the companys SMD trial in the U.S. was treated on February 13, 2012.

Further information about patient eligibility for the dry AMD study and the concurrent study on SMD is also available on http://www.clinicaltrials.gov; ClinicalTrials.gov Identifiers: NCT01345006 , NCT01469832 and NCT01344993.

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc., is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visit http://www.advancedcell.com.

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Stem Cells and Regenerative Medicine for Cardiac Care by Dr. Victor Dzau – Video

Saturday, March 24th, 2012

22-03-2012 12:16 Dr. Victor Dzau is a physician and pioneering translational research scientist, and is widely recognized as one of the most influential medical leaders worldwide. He is currently the James B. Duke Professor of Medicine at Duke University and the President and CEO of Duke University Health System. Dr. Dzau's groundbreaking research established the curent understanding of the renin-angiotensin system, which is now known to underlie a wide range of heart and blood vessel diseases, from hypertension to heart failure. His work led directly to the development of drugs that inhibit this system, that now represent the foundation of modern medical therapy for many cardiac disorders. Dr. Dzau continues to lead an innovative and productive reseach lab, pioneering innovative stem cell and genetic treatments for heart and blood vessel diseases. Dr. Dzau has received numerous honors for his contributions to research and medicine, including the 2011 Henry G. Friesen International Prize in Health Research.

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BioTime CEO Michael D. West to Present at 2012 Maxim Group Growth Conference

Friday, March 23rd, 2012

ALAMEDA, Calif.--(BUSINESS WIRE)--

BioTime, Inc. (NYSE Amex:BTX), a biotechnology company that develops and markets products in the field of regenerative medicine, today announced that Chief Executive Officer, Michael D. West, Ph.D., will present a corporate overview of BioTime and its subsidiaries with an update on recent developments at the 2012 Maxim Group Growth Conference on Monday, March 26, 2012, 11:00 a.m. EDT, at the Grand Hyatt in New York City. The presentation will be webcast and available online at the Investors section of the BioTime website at http://www.biotimeinc.com.

The 5th annual Maxim Group Growth Conference is designed to provide institutional clients with the opportunity to gain an in-depth perspective on the issues affecting the growth of presenting companies. The one-day event will feature more than 80 company presentations across six designated industry tracks including the healthcare and biotechnology sectors.

About BioTime, Inc.

BioTime, headquartered in Alameda, California, is a biotechnology company focused on regenerative medicine and blood plasma volume expanders. Its broad platform of stem cell technologies is developed through subsidiaries focused on specific fields of applications. BioTime develops and markets research products in the field of stem cells and regenerative medicine, including a wide array of proprietary ACTCellerate cell lines, culture media, and differentiation kits. BioTime's wholly owned subsidiary ES Cell International Pte. Ltd. has produced clinical-grade human embryonic stem cell lines that were derived following principles of Good Manufacturing Practice and currently offers them for use in research. BioTime's therapeutic product development strategy is pursued through subsidiaries that focus on specific organ systems and related diseases for which there is a high unmet medical need. BioTime's majority owned subsidiary Cell Cure Neurosciences, Ltd. is developing therapeutic products derived from stem cells for the treatment of retinal and neural degenerative diseases. Cell Cure's minority shareholder Teva Pharmaceutical Industries has an option to clinically develop and commercialize Cell Cure's OpRegen retinal cell product for use in the treatment of age-related macular degeneration. BioTime's subsidiary OrthoCyte Corporation is developing therapeutic applications of stem cells to treat orthopedic diseases and injuries. Another subsidiary, OncoCyte Corporation, focuses on the diagnostic and therapeutic applications of stem cell technology in cancer, including the diagnostic product PanC-DxTM currently being developed for the detection of cancer in blood samples, therapeutic strategies using vascular progenitor cells engineered to destroy malignant tumors. ReCyte Therapeutics, Inc. is developing applications of BioTime's proprietary induced pluripotent stem cell technology to reverse the developmental aging of human cells to treat cardiovascular and blood cell diseases. BioTime's newest subsidiary, LifeMap Sciences, Inc., is developing an online database of the complex cell lineages arising from stem cells to guide basic research and to market BioTime's research products. In addition to its stem cell products, BioTime develops blood plasma volume expanders, blood replacement solutions for hypothermic (low-temperature) surgery, and technology for use in surgery, emergency trauma treatment and other applications. BioTime's lead product, Hextend, is a blood plasma volume expander manufactured and distributed in the U.S. by Hospira, Inc. and in South Korea by CJ CheilJedang Corp. under exclusive licensing agreements. Additional information about BioTime, ReCyte Therapeutics, Cell Cure, OrthoCyte, OncoCyte, BioTime Asia, LifeMap Sciences, and ESI can be found on the web at http://www.biotimeinc.com.

Forward-Looking Statements

Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for BioTime and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of BioTime and its subsidiaries, particularly those mentioned in the cautionary statements found in BioTime's Securities and Exchange Commission filings. BioTime disclaims any intent or obligation to update these forward-looking statements.

To receive ongoing BioTime corporate communications, please click on the following link to join our email alert list: http://phx.corporate-ir.net/phoenix.zhtml?c=83805&p=irol-alerts

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Cosmetic Regenerative Medicine – Video

Thursday, March 15th, 2012

13-03-2012 16:42 Hear Dr. Bowen talk about the exciting field of Regenerative Medicine. The type of regenerative medicine Dr. Bowen practices uses our own adult stem cells to achieve desired results.

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Bioheart and Ageless Partner to Advance Stem Cell Field With Laboratory Training Programs

Thursday, March 15th, 2012

SUNRISE, Fla., March 15, 2012 (GLOBE NEWSWIRE) -- Bioheart, Inc. (BHRT.OB) announced today that it has successfully conducted a laboratory training course in partnership with the Ageless Regenerative Institute, an organization dedicated to the standardization of cell regenerative medicine. The attendees participated in hands on, in depth training in laboratory practices in stem cell science.

"We had students from all over the world attend this first course including physicians, laboratory technicians and students," said Mike Tomas, Bioheart's President and CEO. "Bioheart is pleased to be able to share our 13 years of experience in stem cell research and help expand this growing life science field."

The course included cell culture techniques and quality control testing such as flow cytometry and gram stain. In addition, participants learned how to work in a cleanroom operating according to FDA cGMP standards, regulations used in the manufacture of pharmaceuticals, food and medical devices. Aseptic techniques were also taught as well as cleanroom gowning, environmental monitoring and maintenance.

Future courses are open to physicians, laboratory technicians and students. After graduating the course, attendees are prepared to pursue research and careers in the field of stem cells and regenerative medicine. For more information about the course, contact info@agelessregen.com.

About Bioheart, Inc.

Bioheart is committed to maintaining its leading position within the cardiovascular sector of the cell technology industry delivering cell therapies and biologics that help address congestive heart failure, lower limb ischemia, chronic heart ischemia, acute myocardial infarctions and other issues. Bioheart's goals are to cause damaged tissue to be regenerated, when possible, and to improve a patient's quality of life and reduce health care costs and hospitalizations.

Specific to biotechnology, Bioheart is focused on the discovery, development and, subject to regulatory approval, commercialization of autologous cell therapies for the treatment of chronic and acute heart damage and peripheral vascular disease. Its leading product, MyoCell, is a clinical muscle-derived cell therapy designed to populate regions of scar tissue within a patient's heart with new living cells for the purpose of improving cardiac function in chronic heart failure patients. For more information on Bioheart, visit http://www.bioheartinc.com.

About Ageless Regenerative Institute, LLC

The Ageless Regenerative Institute (ARI) is an organization dedicated to the standardization of cell regenerative medicine. The Institute promotes the development of evidence-based standards of excellence in the therapeutic use of adipose-derived stem cells through education, advocacy, and research. ARI has a highly experienced management team with experience in setting up full scale cGMP stem cell manufacturing facilities, stem cell product development & enhancement, developing point-of-care cell production systems, developing culture expanded stem cell production systems, FDA compliance, directing clinical & preclinical studies with multiple cell types for multiple indications, and more. ARI has successfully treated hundreds of patients utilizing these cellular therapies demonstrating both safety and efficacy. For more information about regenerative medicine please visit http://www.agelessregen.com.

Forward-Looking Statements: Except for historical matters contained herein, statements made in this press release are forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "will," "to," "plan," "expect," "believe," "anticipate," "intend," "could," "would," "estimate," or "continue" or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements.

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Millipore and Toronto non-profit cultivate stem cells in bioreactor

Monday, March 12th, 2012

Robert Shaw, left, commercial director of EMD Millipores Stem Cell Initiative, and Michael May, CEO of the Centre for Commercialization of Regenerative Medicine in Toronto.

EMD Millipore, the Billerica-based life science division of Merck KGaA, said today that it is collaborating with the Centre for Commercialization of Regenerative Medicine in Toronto to develop optimized conditions to cultivate stem cells in a bioreactor.

The two parties will focus on developing a proprietary monitoring and control methodology for robust growth of adherent human pluripotent stem cells in EMD Millipores Mobius CellReady stirred tank bioreactor. The aim is to produce a commercial kit with reagents and associated methodologies for bioreactor culture of stem cells on microcarriers. No value was given for the collaboration.

As the demand for stem cells used in drug discovery and clinical applications grows, effectively translating the promise of stem cells into therapeutic reality will require large-scale, industrialized production under tightly controlled conditions, Robert Shaw, commercial director of EMD Millipores Stem Cell Initiative, said in a statement. He added that current production uses stacks of 2D tissue culture vessels, an expensive and labor-intensive process. The joint project is tackling those challenges, with the goal of large-scale cultivation of stem cells. Shaw said that may accelerate the progress of therapies into the clinic.

EMD Millipore is the first project partner of the regenerative medicine center, said Michael May, CEO of the center, which is using Millipores bioreactor in its product development facility at the University of Torontos Banting Institute. The work began on Feb. 27, 2012.

EMD Millipore has about 10,000 employees, operations in 67 countries and 2010 revenues of $2.2 billion. The company is known as Merck Millipore outside of the United States and Canada.

The regenerative medicine center is a Canadian non-profit organization funded by the Government of Canadas Networks of Centres of Excellence program and six institutional partners. It supports the development of technologies that accelerate the commercialization of stem cell- and biomaterials-based products. The center launched in Torontos Discovery District on June 14, 2011.

Just two weeks ago Charles River Laboratories International Inc. (NYSE: CRL) of Wilmington signed an exclusive license for EMD Millipores TrueSpike technology under which the two will collaborate to integrate TrueSpike into Charles Rivers viral clearance services that aim to improve drug product safety.

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Biostem U.S., Corporation Appoints Heart Surgeon, Thomas W. Prendergast, M.D. to Its Scientific and Medical Board of …

Monday, March 12th, 2012

CLEARWATER, FL--(Marketwire -03/12/12)- Biostem U.S., Corporation (OTCQB: BOSM.PK - News) (Pinksheets: BOSM.PK - News) (Biostem, the Company), a fully reporting public company in the stem cell regenerative medicine sciences sector, announced today the addition of cardiothoracic surgeon Thomas W. Prendergast, M.D. to its Scientific and Medical Board of Advisors (SAMBA).

Biostem CEO, Dwight Brunoehler stated, "The Company is now positioned for growth and international expansion. Adding a world class team of clinical, laboratory, and regulatory experts for our Scientific and Medical Board of Advisors to guide our pursuits is essential. Dr. Prendergast brings a wealth of experience not only in the scientific aspects of stem cell use in regenerative medicine, but also in forging research and international economic development opportunities."

Dr. Prendergast is a busy clinical cardiothoracic surgeon, who performs 200-250 open-heart operations and 5 to 15 heart transplants each year. He is deeply involved in numerous clinical and research activities associated with stem cells and heart repair. He is presently Director of Cardiac Transplantation at Robert Wood Johnson University Hospital in New Brunswick, New Jersey where he holds an Associate Professorship of Surgery at the University of Medicine and Dentistry of New Jersey. In addition to being an active participant in stem cell research program development and teaching medical students and residents, his other interests include medical research funding and humanitarian development of programs for Disabled American Veterans.

Dr. Prendergast received his undergraduate degrees in biophysics and Psychology, as well as his medical degree, at Pennsylvania State University. His general surgery residency was for five years at the University of Massachusetts Medical School. His cardiothoracic surgery training was at the University of Southern California School of Medicine, including the Los Angeles County Medical Center. Subsequent fellowship training included pediatric cardiac surgery at Children's Hospital of LA, along with thoracic transplant fellowships at University of Southern California in Los Angeles and at Temple University Hospital in Philadelphia. He spent three years at the University of Kansas establishing thoracic transplant programs until returning to Temple University Hospital as one of their staff heart and lung transplant surgeons. Subsequent to his time at Temple, he joined up with Newark Beth Israel/St. Barnabas Hospitals, where he assumed directorship as the Chief of Cardiac Transplantation and Mechanical Assistance.

Regarding his appointment to the Biostem U.S. Scientific and Medical Board of Advisors, Dr. Prendergast said, "I am looking forward with excitement to working again with Dwight at Biostem. The expansion plan is sound, well paced, and will afford improved quality of life opportunities to many people around the world."

About Biostem U.S., Corporation

Biostem U.S., Corporation (OTCQB: BOSM.PK - News) (Pinksheets: BOSM.PK - News) is a fully reporting Nevada corporation with offices in Clearwater, Florida. Biostem is a technology licensing company with proprietary technology centered around providing hair re-growth using human stem cells. The company also intends to train and license selected physicians to provide Regenerative Cellular Therapy treatments to assist the body's natural approach to healing tendons, ligaments, joints and muscle injuries by using the patient's own stem cells. Biostem U.S. is seeking to expand its operations worldwide through licensing of its proprietary technology and acquisition of existing stem cell related facilities. The company's goal is to operate in the international biotech market, focusing on the rapidly growing regenerative medicine field, using ethically sourced adult stem cells to improve the quality and longevity of life for all mankind.

More information on Biostem U.S., Corporation can be obtained through http://www.biostemus.com, or by calling Kerry D'Amato, Marketing Director at 727-446-5000.

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EMD Millipore and the Centre for Commercialization of Regenerative Medicine Collaborate to Optimize Conditions for …

Monday, March 12th, 2012

BILLERICA, MASSACHUSETTS and TORONTO, ONTARIO--(Marketwire -03/12/12)- Editors Note: There is a photo associated with this press release.

EMD Millipore, the Life Science division of Merck KGaA, and the Centre for Commercialization of Regenerative Medicine (CCRM) today announced a collaboration to develop optimized conditions for bioreactor-based cultivation of stem cells.

This joint project will focus on the development of a proprietary monitoring and control methodology, enabling robust growth of adherent human pluripotent stem cells in EMD Millipore's Mobius CellReady stirred tank bioreactor. Ultimately, the project will deliver a commercially available kit containing reagents and associated methodologies for bioreactor culture of stem cells on microcarriers.

"As the demand for stem cells used in drug discovery and clinical applications grows, effectively translating the promise of stem cells into therapeutic reality will require large-scale, industrialized production under tightly controlled conditions," states Robert Shaw, Commercial Director of EMD Millipore's Stem Cell Initiative. "At this time, production is typically achieved using stacks of 2D tissue culture vessels, which is an expensive and labor intensive process. This joint project will address those challenges and facilitate optimized, large-scale cultivation of stem cells which can accelerate the progress of therapies into the clinic."

"When CCRM was created, we had industry partnerships like this in mind," says Michael May, CEO of the Centre for Commercialization of Regenerative Medicine. "We are delighted to have EMD Millipore as our first project partner. Their production expertise and technologies will help CCRM to develop products that will benefit industry, academia, and the patient community. We appreciate that EMD Millipore has commissioned us to undertake this project and recognizes our strength in bioprocessing engineering."

CCRM will be employing EMD Millipore's Mobius CellReady stirred tank bioreactor in its product development facility at the University of Toronto's Banting Institute. The work began on February 27, 2012.

For more information, please visit http://www.millipore.com and http://www.ccrm.ca.

About EMD Millipore

EMD Millipore is the Life Science division of Merck KGaA of Germany and offers a broad range of innovative, performance products, services and business relationships that enable our customers' success in research, development and production of biotech and pharmaceutical drug therapies. Through dedicated collaboration on new scientific and engineering insights, and as one of the top three R&D investors in the Life Science Tools industry, EMD Millipore serves as a strategic partner to customers and helps advance the promise of life science.

Headquartered in Billerica, Massachusetts, the division has around 10,000 employees, operations in 67 countries and 2010 revenues of $2.2 billion. EMD Millipore is known as Merck Millipore outside of the U.S. and Canada.

Read the rest here:
EMD Millipore and the Centre for Commercialization of Regenerative Medicine Collaborate to Optimize Conditions for ...

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Predicting the Success of the Late-Stage Cell-Based Cancer Immunotherapy Pipeline?

Sunday, March 11th, 2012

Tweet 


Adam
Feuerstein
(phama and biotech writer with TheStreet.com) has designed his own rule. 

For those who know or follow Adam, this will come as no surprise.  He is
neither short of rules nor opinion and is never shy in his vivid expression of
either.  But this rule is more than a simple expression of informed
opinion. It was born of hard data analysis and has yet to be broken.  In
Adam’s own words, this is how he and his colleague (Mark J. Ratain) came to the
rule they coined the Feuerstein-Ratain Rule:
[We] analyzed the outcomes of
59 phase III clinical trials of cancer drugs going back 10 years, stratified by
the market value of the companies four months prior to trial results being
announced. What we found was a remarkable difference between the market values of companies that had positive and negative
announcements
.  (the list of companies/products used can be found here
)
Specifically, the median market capitalization was approximately
80-fold greater for the companies with positive trials vs. companies with
negative trials. There were no positive trials among the 21 micro-cap companies
(companies with less than $300 million market capitalization) whereas 21 of 27
studies reported by the larger companies analyzed (greater than $1 billion
capitalization) were positive.
Here’s the rule in a nutshell: 
There is a 100% failure rate for phase III cancer
drug trials conducted by micro-cap cancer drug developers
.
The
editorial, entitled “Oncology Micro-Cap Stocks: Caveat Emptor!”, can be
found in Journal of the National Cancer
Institute
 
(JNCI) at http://jnci.oxfordjournals.org/content/early/2011/09/26/jnci.djr375.full.
They identified
drugs that were undergoing evaluation in phase III trials or for regulatory approval
by the US FDA between January 2000 and January 2009. 
They calculated the
company value based on the market value of primary drug sponsor roughly
three months prior to the release of the data.  They concluded that
whether or not a company had pharma in place was not determinative of a drug’s
success but rather that partnerships or acquisitions by Big Pharma can play a
role in determining a drug’s success only in that these deals may increase the
market value of the primary drug sponsor.  That value was the
determinative factor.
This
is Adam’s summary of the analysis they did that led to the “Feuerstein-Ratain Rule”.  
Below
are the important snippets from the analysis behind the rule:
The "Feuerstein-Ratain
rule" is derived from an analysis of 59 phase III clinical trials of
cancer drugs conducted over the past 10 years. We actually had no say
whatsoever in the selection of cancer drugs used in the analysis. The list was
put together by health economist Allan Detsky of Toronto's Mount Sinai Hospital
and his co-authors as part of their paper published in the Journal of the National Cancer
Institute
 suggesting that
doctors entrusted with conducting late-stage cancer drug clinical trials are
using advanced knowledge of the results of these pivotal studies to engage in
illegal insider trading.
Ratain and I used the same list of 59 cancer drug clinical trials,
re-analyzed by market value of the drug sponsors, to debunk Detsky's
insider-trading theory. That's how the "Feuerstein-Ratain rule" came
about, and we published our conclusions in the JNCI alongside Detsky's paper.
To restate our findings:  No positive trials among the
21 micro-cap companies
(companies with less than $300 million market
capitalization) whereas 21 of 27 studies reported by the larger companies analyzed
(greater than $1 billion capitalization) were positive
There were 21 companies on the
list with market values of $300 million or less, with a 0% success rate in
phase III cancer drug clinical trials.
The list also contained 11 companies with market caps between
$300 million and $1 billion. The clinical trial success rate for this mid-tier
or second strata group was 18%. (Two positive clinical trials out of 11.)
Lastly, there were 21 of 27 studies reported by the larger
companies analyzed (greater than $1 billion capitalization) that were positive,
or a 78% success rate.
So
what interesting for us in cell therapy?
It
is interesting to note that the Feuerstein-Ratain Rule is
limited to oncology drugs and all the companies behind them were public. 
Adam has not – nor has anyone else to the best of my knowledge – looked at how
the rule may or may not translate outside of oncology.

Of
the cell therapy companies to have received market approval in US or EU in the
past 10 years, one was public (DNDN) and one was still private (TIG) and went
public shortly therafter in the same year. TiGenix was a private company and is
not in oncology so the analysis arguably does not apply.  However,
Dendreon’s Provenge is an oncology ‘drug’.  Dendreon had a market cap of
about $430M in the 4 months before its ph III data was announced and as such
would have fallen in the 18% likelihood of success category.  That sounds
about right.

I thought it might be interesting to do our own look at what the Rule might say about the pipeline of late-stage cell-based oncology trials.  Following
is a list of cell therapy companies currently in ph III or II/III for oncology:

2010 Onco CT Immunotherapies (late-stage)
* Trial not expected to complete until Q1
2014 so a lot could happen to the market cap in 2012/13.  It also could be
argued that this is not an oncology treatment as per original data set but a
treatment of the side  effects of the primary cancer treatment.
** Trial not expected to complete until Q1
2014 so a lot could happen to the market cap in 2012/13.
*** It could be argued that this is not an
oncology treatment as per original data set but 
a treatment of the side effects of the primary cancer treatment.
+ It could be argued this is not a cell
therapy though we would argue it is.  Others might argue that as a phase II/III
trial with only 60 patients this may not be powered to be a pivotal oncology trial.
^ Trial currently in “suspension” so this
date may be pushed out or trial terminated. It also could be argued that this
is not an oncology treatment as per original data set but a treatment of
the effects of the primary cancer treatment.  Others might argue that as a phase II/III trial with
only 70 patients this may not be powered to be a pivotal oncology trial.
Conclusion:  At the moment it looks like both NovaRx and ERYtech will go to their phase III data completion (June and October 2012 respectively) as private companies.  To qualify under the rule, Cell Medica would have to go public within the year and/or Kiadis would have to go public within the next 25 months. 

The only
companies with cell-based oncology products currently in late-stage trials to
which the Rule would apply are Molmed’s HSV-TK and Newlink Genetics’ HyperAcute
Pancreas.  

Assuming both MolMed and NewLink's trials progress as planned, we won’t know what
they look like under the rule until around Sept 2013 at which time we can assess their
market cap against the Rule.  At the moment, it’s looking pretty bleak for
both of them according to the Rule though at least the NLNK price has been
going in the right direction of late.  

Certainly one would expect trading
volume to dramatically increase on both these as their trial completion dates
near.  It remains to be seen how this will impact price but they would
have to  dramatically increase in market cap (double or triple) to succeed
as the Rule predicts. 

Naturally, this is just one way of looking at the world and, of course, this rule - as with all rules - is meant to be broken.
  

http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com

Source:
http://feeds.feedburner.com/CellTherapyBlog

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Predicting the Success of the Late-Stage Cell-Based Cancer Immunotherapy Pipeline?

Sunday, March 11th, 2012

Tweet 


Adam
Feuerstein
(phama and biotech writer with TheStreet.com) has designed his own rule. 

For those who know or follow Adam, this will come as no surprise.  He is
neither short of rules nor opinion and is never shy in his vivid expression of
either.  But this rule is more than a simple expression of informed
opinion. It was born of hard data analysis and has yet to be broken.  In
Adam’s own words, this is how he and his colleague (Mark J. Ratain) came to the
rule they coined the Feuerstein-Ratain Rule:
[We] analyzed the outcomes of
59 phase III clinical trials of cancer drugs going back 10 years, stratified by
the market value of the companies four months prior to trial results being
announced. What we found was a remarkable difference between the market values of companies that had positive and negative
announcements
.  (the list of companies/products used can be found here
)
Specifically, the median market capitalization was approximately
80-fold greater for the companies with positive trials vs. companies with
negative trials. There were no positive trials among the 21 micro-cap companies
(companies with less than $300 million market capitalization) whereas 21 of 27
studies reported by the larger companies analyzed (greater than $1 billion
capitalization) were positive.
Here’s the rule in a nutshell: 
There is a 100% failure rate for phase III cancer
drug trials conducted by micro-cap cancer drug developers
.
The
editorial, entitled “Oncology Micro-Cap Stocks: Caveat Emptor!”, can be
found in Journal of the National Cancer
Institute
 
(JNCI) at http://jnci.oxfordjournals.org/content/early/2011/09/26/jnci.djr375.full.
They identified
drugs that were undergoing evaluation in phase III trials or for regulatory approval
by the US FDA between January 2000 and January 2009. 
They calculated the
company value based on the market value of primary drug sponsor roughly
three months prior to the release of the data.  They concluded that
whether or not a company had pharma in place was not determinative of a drug’s
success but rather that partnerships or acquisitions by Big Pharma can play a
role in determining a drug’s success only in that these deals may increase the
market value of the primary drug sponsor.  That value was the
determinative factor.
This
is Adam’s summary of the analysis they did that led to the “Feuerstein-Ratain Rule”.  
Below
are the important snippets from the analysis behind the rule:
The "Feuerstein-Ratain
rule" is derived from an analysis of 59 phase III clinical trials of
cancer drugs conducted over the past 10 years. We actually had no say
whatsoever in the selection of cancer drugs used in the analysis. The list was
put together by health economist Allan Detsky of Toronto's Mount Sinai Hospital
and his co-authors as part of their paper published in the Journal of the National Cancer
Institute
 suggesting that
doctors entrusted with conducting late-stage cancer drug clinical trials are
using advanced knowledge of the results of these pivotal studies to engage in
illegal insider trading.
Ratain and I used the same list of 59 cancer drug clinical trials,
re-analyzed by market value of the drug sponsors, to debunk Detsky's
insider-trading theory. That's how the "Feuerstein-Ratain rule" came
about, and we published our conclusions in the JNCI alongside Detsky's paper.
To restate our findings:  No positive trials among the
21 micro-cap companies
(companies with less than $300 million market
capitalization) whereas 21 of 27 studies reported by the larger companies analyzed
(greater than $1 billion capitalization) were positive
There were 21 companies on the
list with market values of $300 million or less, with a 0% success rate in
phase III cancer drug clinical trials.
The list also contained 11 companies with market caps between
$300 million and $1 billion. The clinical trial success rate for this mid-tier
or second strata group was 18%. (Two positive clinical trials out of 11.)
Lastly, there were 21 of 27 studies reported by the larger
companies analyzed (greater than $1 billion capitalization) that were positive,
or a 78% success rate.
So
what interesting for us in cell therapy?
It
is interesting to note that the Feuerstein-Ratain Rule is
limited to oncology drugs and all the companies behind them were public. 
Adam has not – nor has anyone else to the best of my knowledge – looked at how
the rule may or may not translate outside of oncology.

Of
the cell therapy companies to have received market approval in US or EU in the
past 10 years, one was public (DNDN) and one was still private (TIG) and went
public shortly therafter in the same year. TiGenix was a private company and is
not in oncology so the analysis arguably does not apply.  However,
Dendreon’s Provenge is an oncology ‘drug’.  Dendreon had a market cap of
about $430M in the 4 months before its ph III data was announced and as such
would have fallen in the 18% likelihood of success category.  That sounds
about right.

I thought it might be interesting to do our own look at what the Rule might say about the pipeline of late-stage cell-based oncology trials.  Following
is a list of cell therapy companies currently in ph III or II/III for oncology:

2010 Onco CT Immunotherapies (late-stage)
* Trial not expected to complete until Q1
2014 so a lot could happen to the market cap in 2012/13.  It also could be
argued that this is not an oncology treatment as per original data set but a
treatment of the side  effects of the primary cancer treatment.
** Trial not expected to complete until Q1
2014 so a lot could happen to the market cap in 2012/13.
*** It could be argued that this is not an
oncology treatment as per original data set but 
a treatment of the side effects of the primary cancer treatment.
+ It could be argued this is not a cell
therapy though we would argue it is.  Others might argue that as a phase II/III
trial with only 60 patients this may not be powered to be a pivotal oncology trial.
^ Trial currently in “suspension” so this
date may be pushed out or trial terminated. It also could be argued that this
is not an oncology treatment as per original data set but a treatment of
the effects of the primary cancer treatment.  Others might argue that as a phase II/III trial with
only 70 patients this may not be powered to be a pivotal oncology trial.
Conclusion:  At the moment it looks like both NovaRx and ERYtech will go to their phase III data completion (June and October 2012 respectively) as private companies.  To qualify under the rule, Cell Medica would have to go public within the year and/or Kiadis would have to go public within the next 25 months. 

The only
companies with cell-based oncology products currently in late-stage trials to
which the Rule would apply are Molmed’s HSV-TK and Newlink Genetics’ HyperAcute
Pancreas.  

Assuming both MolMed and NewLink's trials progress as planned, we won’t know what
they look like under the rule until around Sept 2013 at which time we can assess their
market cap against the Rule.  At the moment, it’s looking pretty bleak for
both of them according to the Rule though at least the NLNK price has been
going in the right direction of late.  

Certainly one would expect trading
volume to dramatically increase on both these as their trial completion dates
near.  It remains to be seen how this will impact price but they would
have to  dramatically increase in market cap (double or triple) to succeed
as the Rule predicts. 

Naturally, this is just one way of looking at the world and, of course, this rule - as with all rules - is meant to be broken.
  

http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com

Source:
http://feeds.feedburner.com/CellTherapyBlog

Read More...

New Industry Partnership to Strengthen Regenerative Medicine Industry in Canada

Friday, March 9th, 2012

TORONTO, ONTARIO--(Marketwire -03/09/12)- The newest player in the regenerative medicine (RM) field in Canada is taking a collaborative approach to commercializing stem cell and biomaterials products. The Centre for Commercialization of Regenerative Medicine (CCRM) has created an industry consortium that is working together to address real-life bottlenecks in their RM product pipelines.

CCRM's scientific leadership is recognized by the global RM community as being world-leading. According to Michael May, CEO of CCRM, partnering with industry completes the puzzle. "By working with industry, CCRM captures business expertise that informs product development and commercialization. We already had access to some of the best scientific minds in the field and now we have access to seasoned industry experts. This is key to our success and will accelerate product development."

The members of the industry consortium represent the key sectors of the RM industry: therapeutics, devices, reagents, and cells as tools. CCRM has built three core development platforms: reprogramming, cell manufacturing, and biomaterials and tissue mimetics. The intellectual property and infrastructure of CCRM's six research institution partners and support from 20 leading RM companies will enhance Canada's already strong leadership role in the RM field.

"CCRM is uniquely positioned to meet the needs of industry and academia," explains Greg Bonfiglio, Chair of CCRM's Board of Directors. "CCRM boasts scientific expertise and state-of-the-art resources in its development lab and this combination will benefit the regenerative medicine community that can capitalize on our ability to complete projects quickly and cost competitively."

The industry consortium members are as follows:

About the Centre for Commercialization of Regenerative Medicine (CCRM)

CCRM, a Canadian not-for-profit organization funded by the Government of Canada's Networks of Centres of Excellence program and six academic partners, supports the development of technologies that accelerate the commercialization of stem cell- and biomaterials-based technologies and therapies. A network of academics, industry and entrepreneurs, CCRM aims to translate scientific discoveries into marketable products for patients. CCRM launched in Toronto's Discovery District on June 14, 2011.

Continued here:
New Industry Partnership to Strengthen Regenerative Medicine Industry in Canada

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BioTime to Present at ROTH 24th Annual Growth Stock Conference

Friday, March 9th, 2012

ALAMEDA, Calif.--(BUSINESS WIRE)--

BioTime, Inc. (NYSE Amex:BTX), a biotechnology company that develops and markets products in the field of regenerative medicine, today announced that Chief Financial Officer, Peter S. Garcia, will present a corporate overview of BioTime and its subsidiaries at the ROTH 24th Annual Growth Stock Conference. The presentation will take place on Tuesday, March 13, 2012, at 9:30 a.m. PDT at The Ritz-Carlton Hotel in Dana Point, California. The presentation will be webcast and available online at the Investors section of the website at http://www.biotimeinc.com and at http://wsw.com/webcast/roth26/btx/.

ROTH Capital Partners will host more than 400 growth companies at its annual investment conference, March 11-14, 2012, including more than 130 healthcare companies in the biotechnology, healthcare services, medical device, and pharmaceutical sectors.

About BioTime, Inc.

BioTime, headquartered in Alameda, California, is a biotechnology company focused on regenerative medicine and blood plasma volume expanders. Its broad platform of stem cell technologies is developed through subsidiaries focused on specific fields of applications. BioTime develops and markets research products in the field of stem cells and regenerative medicine, including a wide array of proprietary ACTCellerate cell lines, culture media, and differentiation kits. BioTime's wholly owned subsidiary ES Cell International Pte. Ltd. has produced clinical-grade human embryonic stem cell lines that were derived following principles of Good Manufacturing Practice and currently offers them for use in research. BioTime's therapeutic product development strategy is pursued through subsidiaries that focus on specific organ systems and related diseases for which there is a high unmet medical need. BioTime's majority owned subsidiary Cell Cure Neurosciences, Ltd. is developing therapeutic products derived from stem cells for the treatment of retinal and neural degenerative diseases. Cell Cure's minority shareholder Teva Pharmaceutical Industries has an option to clinically develop and commercialize Cell Cure's OpRegen retinal cell product for use in the treatment of age-related macular degeneration. BioTime's subsidiary OrthoCyte Corporation is developing therapeutic applications of stem cells to treat orthopedic diseases and injuries. Another subsidiary, OncoCyte Corporation, focuses on the diagnostic and therapeutic applications of stem cell technology in cancer, including the diagnostic product PanC-DxTM currently being developed for the detection of cancer in blood samples, therapeutic strategies using vascular progenitor cells engineered to destroy malignant tumors. ReCyte Therapeutics, Inc. is developing applications of BioTime's proprietary induced pluripotent stem cell technology to reverse the developmental aging of human cells to treat cardiovascular and blood cell diseases. BioTime's newest subsidiary, LifeMap Sciences, Inc., is developing an online database of the complex cell lineages arising from stem cells to guide basic research and to market BioTime's research products. In addition to its stem cell products, BioTime develops blood plasma volume expanders, blood replacement solutions for hypothermic (low-temperature) surgery, and technology for use in surgery, emergency trauma treatment and other applications. BioTime's lead product, Hextend, is a blood plasma volume expander manufactured and distributed in the U.S. by Hospira, Inc. and in South Korea by CJ CheilJedang Corp. under exclusive licensing agreements. Additional information about BioTime, ReCyte Therapeutics, Cell Cure, OrthoCyte, OncoCyte, BioTime Asia, LifeMap Sciences, and ESI can be found on the web at http://www.biotimeinc.com.

Forward-Looking Statements

Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for BioTime and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of BioTime and its subsidiaries, particularly those mentioned in the cautionary statements found in BioTime's Securities and Exchange Commission filings. BioTime disclaims any intent or obligation to update these forward-looking statements.

To receive ongoing BioTime corporate communications, please click on the following link to join our email alert list:

http://phx.corporate-ir.net/phoenix.zhtml?c=83805&p=irol-alerts

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BioTime to Present at ROTH 24th Annual Growth Stock Conference

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Harvard Bioscience Comments on the Passing of Christopher Lyles

Wednesday, March 7th, 2012

HOLLISTON, Mass., March 6, 2012 (GLOBE NEWSWIRE) -- Harvard Bioscience, Inc. (Nasdaq:HBIO - News), a global developer, manufacturer, and marketer of a broad range of tools to advance life science research and regenerative medicine is deeply saddened to learn of the passing of Mr. Christopher Lyles. Mr. Lyles was a recent recipient of a tracheal transplant regenerated in a Harvard Bioscience InBreath Bioreactor. Currently, we do not know the cause of Mr. Lyle's death. Our thoughts are with his family at this time. His family has released the following statement:

"We, the family of Christopher Lyles, sorrowfully inform you that Christopher passed away this morning, March 5, 2012. Christopher was a recipient and strong advocate of stem cell therapy. We do not want his journey to be in vain. We hope his bravery will pave the way for further research and development and acceptance of stem cell based therapies in the United States. We would like to thank everyone for their thoughts and prayers throughout Christopher's trailblazing journey."

About Harvard Bioscience

Harvard Bioscience ("HBIO") is a global developer, manufacturer and marketer of a broad range of specialized products, primarily apparatus and scientific instruments, used to advance life science research and regenerative medicine. We sell our products to thousands of researchers in over 100 countries primarily through our 850 page catalog (and various other specialty catalogs), our website, through distributors, including GE Healthcare, Thermo Fisher Scientific and VWR, and via our field sales organization. HBIO has sales and manufacturing operations in the United States, the United Kingdom, Sweden, Germany and Spain with additional facilities in France and Canada. For more information, please visit http://www.harvardbioscience.com.

The Harvard Bioscience, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=6426

Forward-looking Statements

The statements made in this press release that are not statements of historical fact are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You can identify these forward-looking statements by our use of such words as "will," "guidance," "objectives," "optimistic," "potential," "future," "expect," "plans," "estimates," "continue," "drive," "strategy," "crucial," "potential," "potentially," "growth," "long-term," "projects," "projected," "produce," "intends," "believes," "goals," "sees," "seek," "develop," "possible," "new," "enabling," "emerging," "opportunity," "pursue" and similar expressions that do not relate to historical matters. Forward-looking statements in this press release may include, but are not limited to, statements or inferences about the HBIO's or management's beliefs or expectations, the field of regenerative medicine, opportunities or potential opportunities in the field of regenerative medicine, HBIO's business strategy, the positioning of HBIO for growth, the market demand and opportunity for HBIO's current products or products it is developing or intends to develop, and HBIO's plans, objectives and intentions that are not historical facts.

These statements involve known and unknown risks, uncertainties and other factors that may cause HBIO's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Factors that may cause HBIO's actual results, performance or achievements to differ materially from those in the forward-looking statements include, but are not limited to, HBIO's failure to successfully expand its product offerings, introduce new products or commercialize new technologies, including in the field of regenerative medicine, decreased demand for the HBIO's products, including products in the field of regenerative medicine, due to changes in our customers' needs, our ability to obtain regulatory approvals, including FDA approval, for our products, including any products in the field of regenerative medicine, the current size or anticipated size of the regenerative medicine market, the existence and size of opportunities in the regenerative medicine market, our financial position, plus risk factors set forth under the heading "Item 1A. Risk Factors" in HBIO's Annual Report on Form 10-K for the fiscal year ended December 31, 2010 or described in HBIO's other public filings. HBIO's results may also be affected by factors of which HBIO is not currently aware. HBIO may not update these forward-looking statements, even though its situation may change in the future, unless it has obligations under the federal securities laws to update and disclose material developments related to previously disclosed information.

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Harvard Bioscience Comments on the Passing of Christopher Lyles

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Histogen Signs License Agreement with Suneva Medical for Cell Conditioned Media-based Aesthetic Products

Tuesday, March 6th, 2012

SAN DIEGO, March 5, 2012 /PRNewswire/ --Histogen Inc., a regenerative medicine company, and Suneva Medical, a privately-held aesthetics company, today announced that they have entered into a license agreement for physician-dispensed aesthetic products containing Histogen's proprietary multipotent cell conditioned media (CCM).

Under the terms of this license agreement, Suneva Medical has acquired exclusive U.S. licensing rights to Histogen's multipotent CCM and the ReGenica branded line of products for topical applications in the licensed market. Suneva Medical will manufacture the ReGenica product line and market it to aesthetic practitioners throughout the U.S. Histogen will receive a transfer price on the CCM, as well as royalties on future sales of ReGenica and product line extensions.

"First, let me say that, as the first step in expanding our business, we are very excited about this particular opportunity as the advent of regenerative medicine is upon us. One of our key business objectives is to find novel products that complement our rapidly growing dermal filler business. We believe Histogen's innovative technology coupled with our proven experience of developing and marketing aesthetic products is a winning combination as it enables us to offer our customers a differentiated product line," stated Nicholas Teti, Chairman and Chief Executive Officer of Suneva Medical.

Through Histogen's technology process, which mimics the embryonic environment including conditions of low oxygen and suspension, cells are triggered to become multipotent, and naturally produce proteins associated with skin renewal and scarless healing. The result is a soluble cell conditioned media containing cell-signaling proteins such as KGF, follistatin, stem cell factor, collagens and laminins, which support the epidermal stem cells that renew skin throughout life. In addition, factors associated with scarring, such as TGF-beta, are decreased or nonexistent.

"The applications for this proprietary multipotent CCM within the field of medical aesthetics are numerous and, based upon the way the proteins within the complex signal the body's own stem cells to rejuvenate and regenerate skin, potentially groundbreaking," said Dr. Gail K. Naughton, CEO and Chairman of the Board at Histogen. "This recognition from Suneva's expert team, with a rich background in developing and marketing aesthetics, validates Histogen's technology and supports the fact that it is different from anything currently in the market."

About Histogen Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products that do not contain embryonic stem cells or animal components. Through Histogen's proprietary bioreactors that mimic the embryonic environment, including low oxygen and suspension, newborn cells are encouraged to naturally produce the vital proteins and growth factors from which the Company has developed its rich product portfolio. Histogen has two product families a proprietary cell conditioned media, and a human Extracellular Matrix (ECM) material. For more information, please visit http://www.histogen.com.

About Suneva Medical Suneva Medical, Inc. is a privately-held aesthetics company focused on developing, manufacturing and commercializing novel, differentiated products for the dermatology, plastic and cosmetic surgery markets. The Company's long-lasting injectable product is marketed as Artefill in the U.S. and Bellafill in Canada to correct facial wrinkles. For more information visit http://www.sunevamedical.com.

Contacts:

For Histogen Inc.:

Eileen Brandt Phone: (858) 200-9520 ebrandt@histogeninc.com

Continued here:
Histogen Signs License Agreement with Suneva Medical for Cell Conditioned Media-based Aesthetic Products

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The Alliance for Regenerative Medicine Statement on Use of Cell Therapies Not Approved by the Federal Drug …

Tuesday, March 6th, 2012

WASHINGTON, DC--(Marketwire -03/05/12)- The Alliance for Regenerative Medicine issued the following statement today: "An article about stem cell treatments taking place in Texas published by Nature last week is extremely troubling. The article suggests that patients are being administered stem cell treatments that have not been systematically demonstrated to be safe and effective therapies through the established FDA regulatory process.

"Cell therapy treatments, including those using adult stem cells, hold the promise of providing patients with treatments and cures for numerous diseases and disabilities. However, FDA regulation is key to ensuring that the treatments available to patients are safe and effective.

"The Alliance for Regenerative Medicine (ARM), a non-profit organization whose mission is to promote increased funding and development of regenerative medicine products, believes cell therapy and regenerative medicine products, including autologous cell therapy products, must go through the rigorous safety testing that is part of the FDA regulatory process before they can be marketed to the public. These regulations are designed to promote safe collection, manufacture, storage, and use of human cells, and cellular and tissue based products. ARM members comply with these rules because they know that FDA oversight helps to prevent patients from exposure to potentially unsafe products.

"We urge all companies developing stem cell treatments to follow FDA rules governing research and product development. ARM remains committed to working with all stakeholders to ensure that safe and effective products reach patients as soon as possible."

About The Alliance for Regenerative Medicine (ARM) The Alliance for Regenerative Medicine (ARM) is a Washington, DC-based non-profit organization that promotes legislative, regulatory, reimbursement, and financing initiatives necessary to facilitate access to life-giving advances in regenerative medicine. ARM also works to increase public understanding of the field and its potential to transform human healthcare, and provides services to support the growth of its member companies and organizations. To learn more about ARM or to become a member, visit http://www.alliancerm.org.

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