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Schizophrenia shares genetic links with autism, genome study shows

May 12th, 2010 8:21 am

Schizophrenia involves some of the same genetic variations as autism and attention deficit disorders, a new whole-genome analysis study has confirmed. [More]

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International Stem Cell and Absorption Systems Confirm Results Showing Stem Cell Derived Corneal Tissue as an Alternative to Animals for Drug Testing

May 12th, 2010 8:21 am

Other Tests Show Tissue's Ability to Focus Light, Pointing to Potential Therapeutic Applications

OCEANSIDE, Calif. – May 10, 2010 – International Stem Cell Corporation (OTCBB: ISCO), http://www.internationalstemcell.com/, the first company to perfect a method of creating human "parthenogenetic" stem cells from unfertilized eggs, announces the results of a second set of experiments confirming that its lab-grown corneal tissue closely mimics the drug absorption and drug metabolism characteristics found in normal corneal tissue. Other tests show that the stem cell derived corneal tissue refracts light, thus providing a further indication of its potential therapeutic value in treating corneal injury and disease.

Two sets of collaborative experiments between ISCO and Absorption Systems have now shown that corneal tissue cultured by ISCO exhibits topical drug absorption barrier properties and tissue-appropriate enzymatic activity, making it a promising model for studying human ocular drug absorption as an alternative to live animal testing. ISCO's human corneal tissue is created in the laboratories of its wholly owned subsidiary, Lifeline Cell Technology (Walkersville, MD).

In a second set of tests conducted by a third party expert, a beam of diverging light was projected through the corneal tissue from different distances, becoming more or less refracted with the changing distance, showing that the corneal tissue was clear and had optical properties that allow the focusing of light. Additional experiments will be conducted to better define these optical characteristics.

According to Jeffrey Janus, Senior VP of ISCO and CEO of Lifeline, "We are very excited to confirm our initial results showing drug absorption that correlates with animal models and add to these results the observation of enzymatic activity. This not only advances our plans to manufacture a product that can be used to reduce the need for tests that use living animals, but it also is one more step toward the potential therapeutic use of this tissue as a treatment for human corneal injury or disease. This has implications, not only in the US, but also in India and Asia, where millions of people suffer from corneal blindness that now goes untreated. The experiments showing light refraction are a tempting indication that this tissue will have therapeutic application."

"There is a large commercial need for a predictive and reproducible non-animal method for testing the safety of ophthalmic drugs and consumer products," said Patrick M. Dentinger, President and CEO of Absorption Systems. "The combined knowledge and expertise of ISCO and Absorption Systems have allowed us to take a step forward toward addressing an unmet need in the field of ophthalmology by creating a unique in vitro model to study human ocular drug absorption without using animals. Our collaboration with ISCO underscores our commitment to helping bring safe drugs to market."

The collaboration between Absorption Systems and ISCO uses Absorption Systems' know-how in creating and characterizing assay systems to develop superior preclinical methods of testing drugs. Such methods can also reduce the use of laboratory animals currently necessary for other tests, including safety testing of consumer products.

ABOUT INTERNATIONAL STEM CELL CORPORATION (ISCO.OB):

International Stem Cell Corporation is a California-based biotechnology company focused on therapeutic and research products. ISCO's core technology, parthenogenesis, results in creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenic, homozygous stem cell line that can be a source of therapeutic cells with minimal immune rejection after transplantation into hundreds of millions of individuals of differing sexes, ages and racial groups. This offers the potential to create the first true stem cell bank, UniStemCell™, while avoiding the ethical issue of using fertilized eggs. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology. More information is available at ISCO's website, http://www.internationalstemcell.com/.

ABOUT ABSORPTION SYSTEMS:

Absorption Systems, founded in 1996, assists pharmaceutical, biotechnology and medical device companies in identifying and overcoming ADMET (Absorption, Distribution, Metabolism, Excretion and Toxicity) barriers in the development of drugs, biologics and medical devices. The company's mission is to continually develop innovative research tools that can be used to accurately predict human outcomes or to explain unanticipated human outcomes when they occur. The CellPort Technologies® platform, a suite of human cell-based tests systems for drug transporter characterization, exemplifies Absorption Systems' commitment to innovation. Absorption Systems has facilities near Philadelphia, PA, and in San Diego, CA, and serves customers throughout the world. For information on the company's comprehensive contract services and applied research programs, please visit http://www.absorption.com/.

To subscribe to receive ongoing corporate communications please click on the following link: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0.

FORWARD-LOOKING STATEMENTS

Statements pertaining to anticipated technological developments and therapeutic applications, and other opportunities for the company and its subsidiary, 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, application of capital resources among competing uses, 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 company's business, particularly those mentioned in the cautionary statements found in the company's Securities and Exchange Commission filings. The company disclaims any intent or obligation to update these forward-looking statements.

Key Words: Stem Cells, Biotechnology, Parthenogenesis

CONTACTS:
International Stem Cell Corporation
Kenneth C. Aldrich, Chairman
760-940-6383
kaldrich@intlstemcell.com
Or
Brian Lundstrom, President
760-640-6383
bl@intlstemcell.com

Read More...

Baking soda can clean your teeth, clear your complexion

May 9th, 2010 8:19 am

(NaturalNews) Many components of the modern western diet – meats, fish, dairy products, most grains, sugars, alcohol and caffeinated drinks (in fact, almost everything except vegetables, millet, most fruits and, as we have just seen, apple cider vinegar) – contribute to one's body becoming too acidic. This in turn can open the door to a variety of problems, some of them (including arthritic complaints) potentially serious if this acidic condition persists for many years.

This is because your body will attempt to compensate by retaining alkaline salts in the bloodstream to offset the increase of tissue acidity. Since your body can only tolerate a small imbalance in blood pH (the acid-alkali balance), it will rob alkaline components from other places – including your body's precious alkaline reserves – in an effort to restore proper pH equilibrium. This can result in heartburn, digestive distress, stomach upset, fatigue and a multitude of other symptoms. Simple, inexpensive kitchen baking soda can fix this. Read more...

Joint Mender for Joint Care

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CSC news links 2010-05-08

May 9th, 2010 8:19 am

For links to recent news items about CSC, visit this [Topsy] page. Examples of two news items that have received attention in the past week:?

New research links ovarian hormones with breast stem-cell growth - Globe and Mail http://bit.ly/brT71E. Hashtag: #cancerSC. Posted to Twitter on Wed May 06, 2010 via TweetDeck. [PubMed Citation]


Broccoli compound limits breast cancer (about sulforaphane) http://bit.ly/9blnNP & http://bit.ly/aOTSDv. Hashtag: #cancerSC. Posted to Twitter on Wed May 05, 2010 via TweetDeck. [PubMed Citation]

Read More...

Baking soda can clean your teeth, clear your complexion

May 9th, 2010 8:17 am

(NaturalNews) Many components of the modern western diet – meats, fish, dairy products, most grains, sugars, alcohol and caffeinated drinks (in fact, almost everything except vegetables, millet, most fruits and, as we have just seen, apple cider vinegar) – contribute to one's body becoming too acidic. This in turn can open the door to a variety of problems, some of them (including arthritic complaints) potentially serious if this acidic condition persists for many years.

This is because your body will attempt to compensate by retaining alkaline salts in the bloodstream to offset the increase of tissue acidity. Since your body can only tolerate a small imbalance in blood pH (the acid-alkali balance), it will rob alkaline components from other places – including your body's precious alkaline reserves – in an effort to restore proper pH equilibrium. This can result in heartburn, digestive distress, stomach upset, fatigue and a multitude of other symptoms. Simple, inexpensive kitchen baking soda can fix this. Read more...

Joint Mender for Joint Care

Read More...

CSC news links 2010-05-08

May 9th, 2010 8:17 am

For links to recent news items about CSC, visit this [Topsy] page. Examples of two news items that have received attention in the past week:?

New research links ovarian hormones with breast stem-cell growth - Globe and Mail http://bit.ly/brT71E. Hashtag: #cancerSC. Posted to Twitter on Wed May 06, 2010 via TweetDeck. [PubMed Citation]


Broccoli compound limits breast cancer (about sulforaphane) http://bit.ly/9blnNP & http://bit.ly/aOTSDv. Hashtag: #cancerSC. Posted to Twitter on Wed May 05, 2010 via TweetDeck. [PubMed Citation]

Read More...

International Stem Cell Corporation Signs Financing Agreement

May 6th, 2010 8:23 am

OCEANSIDE, CA –May 5, 2010 – International Stem Cell Corporation (ISCO.OB), http://www.intlstemcell.com, today announced it has entered into a definitive agreement dated May 4, 2010 (‘the Agreement”) with Socius CG II, Ltd. (“Socius”), pursuant to which Socius has committed to purchase a single tranche of up to $10 million in non-convertible Series F Preferred Stock (the "Preferred Stock") from ISCO. The Company issued a warrant to purchase $13,500,000 worth of the Company’s Common Stock, the exercise price of the warrant being determined by the closing bid price for the Company’s Common Stock on the trading day immediately preceding the date the Company initiates the sale of the Series F Preferred.

The Company anticipates that the Closing of the Preferred Stock sale will take place 20 business days after the issuance of the Warrants. Proceeds from these sales will be used to provide general working capital and to fund additional development of the Company's proprietary Parthenogenetic Stem Cell Lines, development of commercial research products, and other research and development programs and related business activities.

Additional details on the transaction are contained in the Company's Form 8-K filed today with the Securities and Exchange Commission.

A prospectus relating to this offering is available from:
Investor Relations
International Stem Cell Corporation
2595 Jason Court
Oceanside, CA 92056

ABOUT INTERNATIONAL STEM CELL CORPORATION (ISCO.OB):
International Stem Cell Corporation is a California-based biotechnology company focused on therapeutic and research products. ISCO’s core technology, parthenogenesis, results in creation of pluripotent human stem cells from unfertilized oocytes (eggs). ISCO scientists have created the first parthenogenic, homozygous stem cell line that can be a source of therapeutic cells with minimal immune rejection after transplantation into hundreds of millions of individuals of differing sexes, ages and racial groups. This offers the potential to create the first true stem cell bank, UniStemCell™, while avoiding the ethical issue of using fertilized eggs. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology.

FORWARD-LOOKING STATEMENTS:
Statements pertaining to anticipated future events, including the anticipated closing of the sale of Preferred Stock, 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 satisfying the conditions to closing. 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 company's business, particularly those mentioned in the cautionary statements found in the company's Securities and Exchange Commission filings. The company disclaims any intent or obligation to update these forward-looking statements.
Key Words: Stem Cells, Biotechnology, Parthenogenesis

CONTACTS:
International Stem Cell Corporation
Kenneth C. Aldrich, Chairman
760-940-6383
kaldrich@intlstemcell.com
Or
Brian Lundstrom, President
760-940-6383
bl@intlstemcell.com
WEST\21949392.1

Read More...

International Stem Cell Corporation Signs Financing Agreement

May 6th, 2010 8:21 am

OCEANSIDE, CA –May 5, 2010 – International Stem Cell Corporation (ISCO.OB), http://www.intlstemcell.com, today announced it has entered into a definitive agreement dated May 4, 2010 (‘the Agreement”) with Socius CG II, Ltd. (“Socius”), pursuant to which Socius has committed to purchase a single tranche of up to $10 million in non-convertible Series F Preferred Stock (the "Preferred Stock") from ISCO. The Company issued a warrant to purchase $13,500,000 worth of the Company’s Common Stock, the exercise price of the warrant being determined by the closing bid price for the Company’s Common Stock on the trading day immediately preceding the date the Company initiates the sale of the Series F Preferred.

The Company anticipates that the Closing of the Preferred Stock sale will take place 20 business days after the issuance of the Warrants. Proceeds from these sales will be used to provide general working capital and to fund additional development of the Company's proprietary Parthenogenetic Stem Cell Lines, development of commercial research products, and other research and development programs and related business activities.

Additional details on the transaction are contained in the Company's Form 8-K filed today with the Securities and Exchange Commission.

A prospectus relating to this offering is available from:
Investor Relations
International Stem Cell Corporation
2595 Jason Court
Oceanside, CA 92056

ABOUT INTERNATIONAL STEM CELL CORPORATION (ISCO.OB):
International Stem Cell Corporation is a California-based biotechnology company focused on therapeutic and research products. ISCO’s core technology, parthenogenesis, results in creation of pluripotent human stem cells from unfertilized oocytes (eggs). ISCO scientists have created the first parthenogenic, homozygous stem cell line that can be a source of therapeutic cells with minimal immune rejection after transplantation into hundreds of millions of individuals of differing sexes, ages and racial groups. This offers the potential to create the first true stem cell bank, UniStemCell™, while avoiding the ethical issue of using fertilized eggs. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology.

FORWARD-LOOKING STATEMENTS:
Statements pertaining to anticipated future events, including the anticipated closing of the sale of Preferred Stock, 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 satisfying the conditions to closing. 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 company's business, particularly those mentioned in the cautionary statements found in the company's Securities and Exchange Commission filings. The company disclaims any intent or obligation to update these forward-looking statements.
Key Words: Stem Cells, Biotechnology, Parthenogenesis

CONTACTS:
International Stem Cell Corporation
Kenneth C. Aldrich, Chairman
760-940-6383
kaldrich@intlstemcell.com
Or
Brian Lundstrom, President
760-940-6383
bl@intlstemcell.com
WEST21949392.1

Read More...

Google to Invest in Regenerative Medicine

May 5th, 2010 8:43 pm

While the US government prints money to shore up failing and broken business models which no one likes but are considered simply too big (not too important or significant or even useful) to fail, Google is making money and investing it in start ups who expect nothing less than to create "disruptive, even world-changing technologies".

No suggestion here that GOOG is being altruistic, just that this is the way the new entrepreneur and investor class thinks. Opportunity and money are to be found in technologies that improve the way we live, work, play, eat, and think... and perhaps even improve the world.

To Google Ventures this has already meant wind farms, carbon emission reduction systems, green vehicles, and medical cures. To former Microsoft chief scientist Nathan Myhrvold and his high-level think tank, Intellectual Ventures, this means creating TerraPower - a company intending to revolutionize the nuclear power by developing reactors run on waste uranium - and also actively looking at regenerative medicine technologies.

Having formed the fund a little over a year ago, Google is only now starting to make a splash with the fund. Officially the fund has no specific industry focus saying on the Google Ventures website FAQ:

We are interested in a wide range of industries, including (but not limited to) consumer Internet, software, hardware, clean-tech, biotech, health care and others. First and foremost, we're looking for entrepreneurs who are tackling problems in creative and innovative ways, with the potential for significant financial return.

Unofficially and yet not so quietly, Google has named a few broad areas of interest. An article in Monday's New York Times quoted Google Ventures' managing partner, Bill Maris as saying that while they were not going to name particular investment themes, a few broad ares of interest include:

regenerative medicine, bioinformatics, cloud storage, companies that use large data sets, online monetization and mobile.

There it is. Regenerative medicine right there front and center.

In typical Google tradition, Maris, who looks all of 30 years old on the website, has a successfull and multidisciplinary track record. He was involved in founding Web hosting pioneer Burlee.com (now part of Web.com), where he built much of the key computing, network and technological infrastructure.Prior to that, Bill was a biotechnology and healthcare portfolio manager for Stockholm, Sweden-based Investor AB. Bill’s background also includes research at the Duke University Medical Center, Department of Neurobiology.

Google Ventures is said to be aiming at investing about $100 million a year. Any portion of that for regenerative medicine is more than welcome.

While traditional VC money remains reticent to back RM in any signifant way, Google's move confirms a trend we've been seeing and talking about at the Cell Therapy Group for the past 12 months or so. The multinational lifescience, biopharmaceutical, and healthcare companies along with strategic investors all now have regenerative medicine on their radar. They are all quietly and not-so quietly developing internal and external regenerative medicine strategies.

Please join us in welcoming regenerative medicine to the radar screen. It's bound to be an exciting ride ahead.

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

Health care reform bill dooms America to Pharma-dominated sickness and suffering

May 3rd, 2010 8:23 am

Today the medical mafia struck another devastating blow to the health and freedom of all Americans. With the support of an inarguably corrupt Congress that has simply abandoned the real needs of the American people, the sick-care industry has locked in a high-profit scheme of disease and monopoly-priced pharmaceuticals in a nation that can ill afford either one.

And this Pharma-funded betrayal, it turns out, was led by the Democrats. Passed on a 219-212 vote that was only accomplished thanks to closed-door, last-minute secret meetings among the last holdouts, this new legislation puts America under the stranglehold of the medical mafia while doing absolutely nothing to address real health care reform. There is no mention in the bill Read more...

Youtharia for Anti-Aging & Longevity

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Health care reform bill dooms America to Pharma-dominated sickness and suffering

May 3rd, 2010 8:21 am

Today the medical mafia struck another devastating blow to the health and freedom of all Americans. With the support of an inarguably corrupt Congress that has simply abandoned the real needs of the American people, the sick-care industry has locked in a high-profit scheme of disease and monopoly-priced pharmaceuticals in a nation that can ill afford either one.

And this Pharma-funded betrayal, it turns out, was led by the Democrats. Passed on a 219-212 vote that was only accomplished thanks to closed-door, last-minute secret meetings among the last holdouts, this new legislation puts America under the stranglehold of the medical mafia while doing absolutely nothing to address real health care reform. There is no mention in the bill Read more...

Youtharia for Anti-Aging & Longevity

Read More...

CSC news links 2010-05-01

May 2nd, 2010 8:21 am

For links to recent news items, visit these [Twitter] or [FriendFeed] pages. Examples of two news items that have received attention:?

Read More...

More about presentations at AACR10

May 2nd, 2010 8:21 am

Five presentations at the 101th annual meeting of the American Association of Cancer Research were highlighted a news release from Geron Corporation (dated March 3, 2010). One presentation that had an explicit focus on CSC was this poster:

Imetelstat, a telomerase inhibitor in phase I trials in solid tumor and hematological malignancies, has broad activity against multiple types of cancer stem cells [Presentation Abstract].

Also mentioned in the news release was an oral presentation by Jerry W Shay, given as part of the Major Symposium entitled: Role of Telomeres and Telomerase in Chromosomal Stability and Disease [Session Detail]. The presentation was:

Role of telomerase in normal and neoplastic stem cells [Presentation Abstract].

Another poster about the telomerase inhibitor imetelstat (GRN163L) was:

Sensitivity and resistance of non-small cell lung cancer to the telomerase inhibitor imetelstat [Presentation Abstract].

Comments: A search of the ClinicalTrials.gov database for GRN163L revealed 6 trials. Four were ongoing, but not recruiting participants. Two were still recruiting: 1) Safety and Dose Study of GRN163L Administered to Patients With Refractory or Relapsed Solid Tumor Malignancies; 2) A Study of GRN163L With Paclitaxel and Bevacizumab to Treat Patients With Locally Recurrent Or Metastatic Breast Cancer.

An analogous search for imetelstat yielded the same 6 trials. All 6 trials have been sponsored by Geron Corporation.

Read More...

CSC news links 2010-05-01

May 2nd, 2010 8:20 am

For links to recent news items, visit these [Twitter] or [FriendFeed] pages. Examples of two news items that have received attention:?

Read More...

More about presentations at AACR10

May 2nd, 2010 8:20 am

Five presentations at the 101th annual meeting of the American Association of Cancer Research were highlighted a news release from Geron Corporation (dated March 3, 2010). One presentation that had an explicit focus on CSC was this poster:

Imetelstat, a telomerase inhibitor in phase I trials in solid tumor and hematological malignancies, has broad activity against multiple types of cancer stem cells [Presentation Abstract].

Also mentioned in the news release was an oral presentation by Jerry W Shay, given as part of the Major Symposium entitled: Role of Telomeres and Telomerase in Chromosomal Stability and Disease [Session Detail]. The presentation was:

Role of telomerase in normal and neoplastic stem cells [Presentation Abstract].

Another poster about the telomerase inhibitor imetelstat (GRN163L) was:

Sensitivity and resistance of non-small cell lung cancer to the telomerase inhibitor imetelstat [Presentation Abstract].

Comments: A search of the ClinicalTrials.gov database for GRN163L revealed 6 trials. Four were ongoing, but not recruiting participants. Two were still recruiting: 1) Safety and Dose Study of GRN163L Administered to Patients With Refractory or Relapsed Solid Tumor Malignancies; 2) A Study of GRN163L With Paclitaxel and Bevacizumab to Treat Patients With Locally Recurrent Or Metastatic Breast Cancer.

An analogous search for imetelstat yielded the same 6 trials. All 6 trials have been sponsored by Geron Corporation.

Read More...

Latest Cell Therapy Approval by FDA. Dendreon’s Provenge.

April 30th, 2010 8:22 am

It has been a long-time coming. It has been hyped and scoffed, bet against and hoped for, but now none of that matters. It's here. Dendreon has brought Provenge to market. Here, in the word's of the FDA...

FDA NEWS RELEASE

For Immediate Release: April 29, 2010

FDA Approves a Cellular Immunotherapy for Men with Advanced Prostate Cancer

The U.S. Food and Drug Administration today approved Provenge (sipuleucel-T), a new therapy for certain men with advanced prostate cancer that uses their own immune system to fight the disease.

Provenge is indicated for the treatment of asymptomatic or minimally symptomatic prostate cancer that has spread to other parts of the body and is resistant to standard hormone treatment.

Prostate cancer is the second most common type of cancer among men in the United States, behind skin cancer, and usually occurs in older men. In 2009, an estimated 192,000 new cases of prostate cancer were diagnosed and about 27,000 men died from the disease, according to the National Cancer Institute.

“The availability of Provenge provides a new treatment option for men with advanced prostate cancer, who currently have limited effective therapies available,” said Karen Midthun, M.D., acting director of the FDA’s Center for Biologics Evaluation and Research.

Provenge is an autologous cellular immunotherapy, designed to stimulate a patient’s own immune system to respond against the cancer. Each dose of Provenge is manufactured by obtaining a patient’s immune cells from the blood, using a machine in a process known as leukapheresis. To enhance their response against the cancer, the immune cells are then exposed to a protein that is found in most prostate cancers, linked to an immune stimulating substance. After this process, the patient’s own cells are returned to the patient to treat the prostate cancer. Provenge is administered intravenously in a three-dose schedule given at about two-week intervals.

The effectiveness of Provenge was studied in 512 patients with metastatic hormone treatment refractory prostate cancer in a randomized, double-blind, placebo-controlled, multicenter trial, which showed an increase in overall survival of 4.1 months. The median survival for patients receiving Provenge treatments was 25.8 months, as compared to 21.7 months for those who did not receive the treatment.

Almost all of the patients who received Provenge had some type of adverse reaction. Common adverse reactions reported included chills, fatigue, fever, back pain, nausea, joint ache and headache. The majority of adverse reactions were mild or moderate in severity. Serious adverse reactions, reported in approximately one quarter of the patients receiving Provenge, included some acute infusion reactions and stroke. Cerebrovascular events, including hemorrhagic and ischemic strokes, were observed in 3.5 percent of patients in the Provenge group compared with 2.6 percent of patients in the control group.

Provenge is manufactured by Seattle-based Dendreon Corp.

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

Latest Cell Therapy Approval by FDA. Dendreon’s Provenge.

April 30th, 2010 8:19 am

It has been a long-time coming. It has been hyped and scoffed, bet against and hoped for, but now none of that matters. It's here. Dendreon has brought Provenge to market. Here, in the word's of the FDA...

FDA NEWS RELEASE

For Immediate Release: April 29, 2010

FDA Approves a Cellular Immunotherapy for Men with Advanced Prostate Cancer

The U.S. Food and Drug Administration today approved Provenge (sipuleucel-T), a new therapy for certain men with advanced prostate cancer that uses their own immune system to fight the disease.

Provenge is indicated for the treatment of asymptomatic or minimally symptomatic prostate cancer that has spread to other parts of the body and is resistant to standard hormone treatment.

Prostate cancer is the second most common type of cancer among men in the United States, behind skin cancer, and usually occurs in older men. In 2009, an estimated 192,000 new cases of prostate cancer were diagnosed and about 27,000 men died from the disease, according to the National Cancer Institute.

“The availability of Provenge provides a new treatment option for men with advanced prostate cancer, who currently have limited effective therapies available,” said Karen Midthun, M.D., acting director of the FDA’s Center for Biologics Evaluation and Research.

Provenge is an autologous cellular immunotherapy, designed to stimulate a patient’s own immune system to respond against the cancer. Each dose of Provenge is manufactured by obtaining a patient’s immune cells from the blood, using a machine in a process known as leukapheresis. To enhance their response against the cancer, the immune cells are then exposed to a protein that is found in most prostate cancers, linked to an immune stimulating substance. After this process, the patient’s own cells are returned to the patient to treat the prostate cancer. Provenge is administered intravenously in a three-dose schedule given at about two-week intervals.

The effectiveness of Provenge was studied in 512 patients with metastatic hormone treatment refractory prostate cancer in a randomized, double-blind, placebo-controlled, multicenter trial, which showed an increase in overall survival of 4.1 months. The median survival for patients receiving Provenge treatments was 25.8 months, as compared to 21.7 months for those who did not receive the treatment.

Almost all of the patients who received Provenge had some type of adverse reaction. Common adverse reactions reported included chills, fatigue, fever, back pain, nausea, joint ache and headache. The majority of adverse reactions were mild or moderate in severity. Serious adverse reactions, reported in approximately one quarter of the patients receiving Provenge, included some acute infusion reactions and stroke. Cerebrovascular events, including hemorrhagic and ischemic strokes, were observed in 3.5 percent of patients in the Provenge group compared with 2.6 percent of patients in the control group.

Provenge is manufactured by Seattle-based Dendreon Corp.

http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com
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Stem cells for a Webby!

April 28th, 2010 8:21 am

I know I haven't been a very good blogger for quite some time but I wanted to pass on a letter I just received from my friend James Price as a Charter member of the Canadian Stem Cell Foundation. They're going for a Webby award. You don't have to be Canadian to support their cause - you just have to:

  • believe in the power of interactive, online network-based activism,
  • support the potential of stem cells to change people's lives, and
  • wanna have a little fun raising awareness for our otherwise-sometimes-stodgy-science!

Go vote - it's good for you and the world! (WARNING: you might find out some things about some pretty cool stuff nominated in the other categories while you're there).

CSCFHeader

Dear Lee,

I'd like to thank everyone who has voted and helped spread the word about the Webby Awards nomination. We think a big part of the Foundation's success, and especially this nomination, is due to your enthusiasm, creativity and support.

That support has taken us a long way. Right now, we're in the lead for Best Activism Website. But our lead is narrow, only 3%, so we need you to pull out all the stops. There are only two days left to vote, so let's make sure it's a win for stem cells!

Why Activism?

A large part of what makes our website and social media pages work is the Charter community. All the material we create - the Stem Cell Charter, "Rock Star Scientists" video and all the posts on our social media pages - are designed to give the stem cell movement a voice - your voice. You are the most important part of getting the word out about stem cell science and helping people see the amazing potential of the field.

Voting and encouraging others to vote is a perfect way to do this. Tweet, post, blog, email and shout your support from the rooftops. Let's show the world how important we think stem cell science is.

How to vote

Step 1: Click HERE and fill in your email address and a password.

Step 2: You will receive an email from the Webby Awards - click the link to activate your account.

Step 3: Go HERE TO VOTE and choose RENEW THE WORLD.

Voting closes at midnight on April 29th. We have two days left!

webby banner

Thanks for your support,


James Price
President & CEO



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

Stem cells for a Webby!

April 28th, 2010 8:19 am

I know I haven't been a very good blogger for quite some time but I wanted to pass on a letter I just received from my friend James Price as a Charter member of the Canadian Stem Cell Foundation. They're going for a Webby award. You don't have to be Canadian to support their cause - you just have to:

  • believe in the power of interactive, online network-based activism,
  • support the potential of stem cells to change people's lives, and
  • wanna have a little fun raising awareness for our otherwise-sometimes-stodgy-science!

Go vote - it's good for you and the world! (WARNING: you might find out some things about some pretty cool stuff nominated in the other categories while you're there).

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Dear Lee,

I'd like to thank everyone who has voted and helped spread the word about the Webby Awards nomination. We think a big part of the Foundation's success, and especially this nomination, is due to your enthusiasm, creativity and support.

That support has taken us a long way. Right now, we're in the lead for Best Activism Website. But our lead is narrow, only 3%, so we need you to pull out all the stops. There are only two days left to vote, so let's make sure it's a win for stem cells!

Why Activism?

A large part of what makes our website and social media pages work is the Charter community. All the material we create - the Stem Cell Charter, "Rock Star Scientists" video and all the posts on our social media pages - are designed to give the stem cell movement a voice - your voice. You are the most important part of getting the word out about stem cell science and helping people see the amazing potential of the field.

Voting and encouraging others to vote is a perfect way to do this. Tweet, post, blog, email and shout your support from the rooftops. Let's show the world how important we think stem cell science is.

How to vote

Step 1: Click HERE and fill in your email address and a password.

Step 2: You will receive an email from the Webby Awards - click the link to activate your account.

Step 3: Go HERE TO VOTE and choose RENEW THE WORLD.

Voting closes at midnight on April 29th. We have two days left!

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Thanks for your support,


James Price
President & CEO



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

Beetroot Juice May Boost Stamina

April 27th, 2010 8:23 am

(HealthDay News) -- Beetroot juice can boost physical stamina and increase exercise endurance by up to 16 percent, a new British study shows.

The researchers found that nitrate in beetroot juice reduces oxygen uptake to a degree that can't be achieved by any other means. The findings could benefit endurance athletes, elderly people and those with cardiovascular, respiratory or metabolic diseases, the study authors suggest.

The study included eight men, aged 19 to 38, who drank 500 milliliters a day of organic beetroot juice for six consecutive days. They then completed a series of tests on an exercise bike. The same tests were repeated after the men drank the same amount of a placebo (blackcurrant cordial) for six days.

After drinking the beetroot juice, the men were able to cycle for an average of 11.25 minutes -- 92 seconds longer than after consuming the placebo drink. The men also had a lower resting blood pressure after they drank the beetroot juice, the researchers found.

The study was published Aug. 6 in the Journal of Applied Physiology. Read more...



Joint Mender for Joint Care

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