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Category Archives: Cell Therapy
Cytomedix to Showcase Aldagen’s Promising Autologous Cell Therapy Technology at Two Regenerative Medicine Meetings
Posted: February 16, 2012 at 5:50 pm
GAITHERSBURG, MD--(Marketwire -02/16/12)- Cytomedix, Inc. (OTC.BB: CMXI.OB - News) (the "Company"), a leading developer of biologically active regenerative therapies for wound care, inflammation and angiogenesis, today announced that Chief Operating Officer Edward L. Field will present a clinical overview of Aldagen's autologous cell therapy technology at two upcoming meetings: The Cell Society's 2nd Annual Clinical Meeting being held February 17-18 at the Coronado Marriott Resort in San Diego; and the 7th Annual New York Stem Cell Summit being held on February 21 at Bridgewaters New York in New York City.
Mr. Field will present during the session, "Commercialization Opportunities with Adult Stem Cell Therapies," on Friday, February 17 from 8:00 a.m. to 10:00 a.m. Pacific time at the Cell Society meeting.
Cell Society International is a non-profit organization dedicated to advancing the clinical application of adult stem cell therapies worldwide. Cell Society's 2nd Annual Clinical Meeting will continue in the tradition established at the 1st Annual Meeting and will offer a unique opportunity for multidisciplinary, international clinical collaboration designed to enhance understanding and thought-provoking insight into treatments and cures for disease and agonizing medical conditions. This year's clinical focus will center on therapies particularly relevant to cardiology, neurology, and orthopedic and plastic surgery.
At the Stem Cell Summit, Mr. Field will present at 2:35 p.m. Eastern time. This meeting showcases more than 30 of the world's leaders in this rapidly evolving industry. The New York Stem Cell Summit brings the future of this dynamic industry to life for investors, industry, practitioners and analysts so they can learn about the investment opportunities in the stem cell marketplace, groundbreaking stem cell products that physicians use today and the growing market potential in terms of revenues.
About Cytomedix, Inc.
Cytomedix, Inc. develops, sells and licenses regenerative biological therapies primarily for wound care, inflammation and angiogenesis. The Company markets the AutoloGel™ System, a device for the production of autologous platelet rich plasma ("PRP") gel for use on a variety of exuding wounds; the Angel® Whole Blood Separation System, a blood processing device and disposable products used for the separation of whole blood into red cells, platelet poor plasma ("PPP") and PRP in surgical settings; and the activAT® Autologous Thrombin Processing Kit, which produces autologous thrombin serum from PPP. The activAT® kit is sold exclusively in Europe and Canada, where it provides a completely autologous, safe alternative to bovine-derived products. On February 8, 2012 Cytomedix announced the acquisition of Aldagen, a biopharmaceutical company developing regenerative cell therapies based on its proprietary ALDH bright cell ("ALDHbr") technology, currently in a Phase 2 trial for the treatment of ischemic stroke. For additional information please visit http://www.cytomedix.com
Safe Harbor Statement
Statements contained in this communication not relating to historical facts are forward-looking statements that are intended to fall within the safe harbor rule for such statements under the Private Securities Litigation Reform Act of 1995. The information contained in the forward-looking statements is inherently uncertain, and Cytomedix' actual results may differ materially due to a number of factors, many of which are beyond Cytomedix' ability to predict or control, including many among others, risks and uncertainties related to the Company's ability to successfully integrate this acquisition, to successfully manage contemplated clinical trials, to manage and address the capital needs, human resource, management, compliance and other challenges of a larger, more complex and intergrated business enterprise, viability and effectiveness of the Company's sales approach and overall marketing strategies, commercial success or acceptance by the medical community, competitive responses, the Company's ability to raise additional capital and to continue as a going concern, and Cytomedix's ability to execute on its strategy to market the AutoloGel™ System as contemplated. To the extent that any statements made here are not historical, these statements are essentially forward-looking. The Company uses words and phrases such as "believes," "forecasted," "projects," "is expected," "remain confident," "will" and/or similar expressions to identify forward-looking statements in this press release. Undue reliance should not be placed on forward-looking information. These forward-looking statements are subject to known and unknown risks and uncertainties that could cause actual events to differ from the forward-looking statements. More information about some of these risks and uncertainties may be found in the reports filed with the Securities and Exchange Commission by Cytomedix, Inc. Cytomedix operates in a highly competitive and rapidly changing business and regulatory environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. Except as is expressly required by the federal securities laws, Cytomedix undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason. Additional risks that could affect our future operating results are more fully described in our U.S. Securities and Exchange Commission filings, including our Annual Report for the year ended December 31, 2010, filed with the SEC and other subsequent filings. These filings are available at http://www.sec.gov.
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Cytomedix to Showcase Aldagen's Promising Autologous Cell Therapy Technology at Two Regenerative Medicine Meetings
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Pathfinder to Present at New York Stem Cell Summit
Posted: February 16, 2012 at 5:50 pm
CAMBRIDGE, Mass., Feb. 16, 2012 (GLOBE NEWSWIRE) -- Pathfinder Cell Therapy, Inc. ("Pathfinder," or "the Company") (OTCQB:PFND.PK - News), a biotechnology company focused on the treatment of diseases characterized by organ-specific cell damage, today announced that Richard L. Franklin, M.D., Ph.D., Founder, CEO and President of Pathfinder, will present at the 7th Annual New York Stem Cell Summit being held on Tuesday, February 21, 2012.
Event: 7th Annual New York Stem Cell Summit
Date: Tuesday, February 21, 2012
Place: Bridgewaters New York, 11 Fulton Street, New York, NY
Time: 3:35 pm ET
Dr. Franklin will be providing an overview of the Company's novel Pathfinder Cell therapy.
The New York Stem Cell Summit brings together stem cell company executives, researchers, investors and physicians to explore investment opportunities in stem cell research and innovation. More information can be found at http://www.stemcellsummit.com.
About Pathfinder
Pathfinder is developing a novel cell-based therapy and has generated encouraging preclinical data in models of diabetes, renal disease, myocardial infarction, and critical limb ischemia, a severe form of peripheral vascular disease. Leveraging its internal discovery of Pathfinder Cells ("PCs") Pathfinder is pioneering a new field in regenerative medicine.
PCs are a newly identified mammalian cell type present in very low quantities in a variety of organs, including the kidney, liver, pancreas, lymph nodes, myometrium, bone marrow and blood. Early studies indicate that PCs stimulate regeneration of damaged tissues without the cells themselves being incorporated into the newly generated tissue. Based on testing to date, the cells appear to be "immune privileged," and their effects appear to be independent of the tissue source of PCs. For more information please visit: http://www.pathfindercelltherapy.com.
FORWARD LOOKING STATEMENTS
This press release contains forward-looking statements. You should be aware that our actual results could differ materially from those contained in the forward-looking statements, which are based on management's current expectations and are subject to a number of risks and uncertainties, including, but not limited to, our inability to obtain additional required financing; costs and delays in the development and/or FDA approval, or the failure to obtain such approval, of our product candidates; uncertainties or differences in interpretation in clinical trial results, if any; our inability to maintain or enter into, and the risks resulting from our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products; competitive factors; our inability to protect our patents or proprietary rights and obtain necessary rights to third party patents and intellectual property to operate our business; our inability to operate our business without infringing the patents and proprietary rights of others; general economic conditions; the failure of any products to gain market acceptance; technological changes; and government regulation. We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements.
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Pathfinder to Present at New York Stem Cell Summit
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Pathfinder to Present at New York Stem Cell Summit
Posted: February 16, 2012 at 1:56 pm
CAMBRIDGE, Mass., Feb. 16, 2012 (GLOBE NEWSWIRE) -- Pathfinder Cell Therapy, Inc. ("Pathfinder," or "the Company") (OTCQB:PFND.PK - News), a biotechnology company focused on the treatment of diseases characterized by organ-specific cell damage, today announced that Richard L. Franklin, M.D., Ph.D., Founder, CEO and President of Pathfinder, will present at the 7th Annual New York Stem Cell Summit being held on Tuesday, February 21, 2012.
Event: 7th Annual New York Stem Cell Summit
Date: Tuesday, February 21, 2012
Place: Bridgewaters New York, 11 Fulton Street, New York, NY
Time: 3:35 pm ET
Dr. Franklin will be providing an overview of the Company's novel Pathfinder Cell therapy.
The New York Stem Cell Summit brings together stem cell company executives, researchers, investors and physicians to explore investment opportunities in stem cell research and innovation. More information can be found at http://www.stemcellsummit.com.
About Pathfinder
Pathfinder is developing a novel cell-based therapy and has generated encouraging preclinical data in models of diabetes, renal disease, myocardial infarction, and critical limb ischemia, a severe form of peripheral vascular disease. Leveraging its internal discovery of Pathfinder Cells ("PCs") Pathfinder is pioneering a new field in regenerative medicine.
PCs are a newly identified mammalian cell type present in very low quantities in a variety of organs, including the kidney, liver, pancreas, lymph nodes, myometrium, bone marrow and blood. Early studies indicate that PCs stimulate regeneration of damaged tissues without the cells themselves being incorporated into the newly generated tissue. Based on testing to date, the cells appear to be "immune privileged," and their effects appear to be independent of the tissue source of PCs. For more information please visit: http://www.pathfindercelltherapy.com.
FORWARD LOOKING STATEMENTS
This press release contains forward-looking statements. You should be aware that our actual results could differ materially from those contained in the forward-looking statements, which are based on management's current expectations and are subject to a number of risks and uncertainties, including, but not limited to, our inability to obtain additional required financing; costs and delays in the development and/or FDA approval, or the failure to obtain such approval, of our product candidates; uncertainties or differences in interpretation in clinical trial results, if any; our inability to maintain or enter into, and the risks resulting from our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products; competitive factors; our inability to protect our patents or proprietary rights and obtain necessary rights to third party patents and intellectual property to operate our business; our inability to operate our business without infringing the patents and proprietary rights of others; general economic conditions; the failure of any products to gain market acceptance; technological changes; and government regulation. We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements.
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Pathfinder to Present at New York Stem Cell Summit
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First local dogs receive ‘amazing’ stem-cell therapy
Posted: February 16, 2012 at 4:21 am
Just before 10 a.m. Tuesday, Jake — a hobbling, 12-year-old yellow Labrador retriever — went into surgery at the Stanley Veterinary Clinic in Overland Park with crippling arthritis, no longer able to run without pain or even walk down stairs.
He had already been on months of medications that seemed to turn the normally happy dog sad. And hip and joint replacements costing tens of thousands of dollars were not feasible, said owners Mike and Elizabeth LeBlanc of Leawood.Still, their 8-year-old daughter, Mia, had just one request at Christmas. “All I want is for Jake to feel better,” she wrote.So, on Tuesday morning, Jake became one of the first canines in the Kansas City area to undergo a somewhat new and controversial procedure in which stem cells were harvested from the fat of his own body and then injected into his joints. The expectation is that within a few weeks the cells will regenerate missing cartilage and turn his arthritic joints healthy again.“It’s amazing,” said veterinarian Les E. Pelfrey, who conducted the procedure. “A few weeks later, these guys are running up and down.”The stem-cell procedure, which has gained notice in recent years with anecdotal stories of success on YouTube and cable television, remains controversial not only for its quick adoption in veterinary clinics nationwide, but also because some researchers say it remains scientifically unproven and expensive, at $1,800 or more per treatment.“Let me tell you one thing,” said James L. Cook, a professor of orthopedics at the University of Missouri’s College of Veterinary Medicine. “I don’t want to write off stem cells. Stem cells may hold the key for truly restorative medicine.”In horses, stems cells have been shown to help rejuvenate damaged tendons and other problems. They are being tested for cardiac problems.“But in the joints for dogs with arthritis? No way,” Cook said. “I would never recommend anyone get this done.”Stem cells essentially are the equivalent of young and impressionable cells whose genetic gears have yet to determine their fate. Because they are so young, they theoretically can turn into any kind of cell, from cartilage to neurons. In humans, stem cells have long been held out as possible therapy for diseases such as Parkinson’s.The problem, Cook said, is that although a few studies have shown that the injection of stem cells into arthritic canine joints does reduce pain, compared with “control” dogs not injected with stems cells, no studies have convincingly shown that stems cells are any better at helping dogs than the current, and less expensive, standard of care. That typically involves a combination of weight loss, pain medications and, when necessary, injections of hyaluronic acid, a slippery substance that often goes missing in arthritis. Those injections, given a couple of times a year, cost less than $100 each.Moreover, even if the stem cells work, no one knows at this point how long the improvement will persist, although some vets have noted benefits lasting a year or more.“We know for sure that it (stem cell injections) does have some palliative effects. It can make symptoms better,” Cook said. “And we do know for sure that it does not regenerate cartilage in arthritic joints. The palliative effects are not as good, or no better, than hyaluronic acid injections.”That is far from the case being made by companies now promoting stem-cell therapy in dogs, or owners who believe in it.A number of stem-cell companies have emerged in recent years. Chief among them are Vet-Stem, based in Poway, Calif., and MediVet America, a division of MediVet, based in Sydney, Australia, which notes that it is currently conducting studies on canines, stem cells and cartilage regeneration.Both use largely similar technologies and methods. At the vet’s office, the dog undergoes a quick procedure in which a bolus of fat about the size of a golf ball is taken from above the shoulder.The fat is processed and treated with chemicals to extract millions of stem cells. Some of those cells are then injected into a dog’s damaged joints; the rest enter the body through an intravenous line into the bloodstream.One prime difference between the Vet-Stem and MediVet systems is that Vet-Stem costs about $3,000 or more.Vet-Stem requires the veterinarian to ship the fat sample to California, where it is processed and sent back for injection. Several dogs in the Kansas City area have been injected with stem cells from Vet-Stem.The MediVet system costs pet owners about $1,800. It provides veterinarians with a kit to process the stem cells in their own offices over about four hours. Dogs are injected with stems cells on the same day the fat is removed. The pet typically goes home the next day.In Topeka, the University Bird and Small Animal Clinic has used the MediVet kit and system with what it says are positive results on about 40 dogs since November 2010. A veterinarian there, Larry Snyder, helped train Pelfrey in Overland Park.Snyder came to the clinic two weeks ago to perform the procedure on another hobbled yellow Labrador retriever, Milo, owned by dentist Jon Finley and his wife, Sharon, in Leawood.“Dr. Pelfrey and Mrs. Finley didn’t tell me how much this procedure was going to cost,” Jon Finley said, “and I’d rather you not tell me. No matter what, he’s walking better, standing upright, feeling better. I can’t help but think he’s going to get better and better.”Jake’s owner said that, whatever the outcome, she knows that the procedure is not a cure.“I’m hoping this gives him a better quality of life,” Elizabeth LeBlanc said. “I got him when he was just 6 weeks old. He was such a blessing. It will be worth it, even if I can give him one more great summer.”
To reach Eric Adler, call 816-234-4431 or send email to eadler@kcstar.com.
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First local dogs receive ‘amazing’ stem-cell therapy
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Dog Receives First-Ever Stem Cell Therapy in Kansas City
Posted: February 15, 2012 at 1:18 am
Stanley, Kan. — It’s a special Valentine’s Day gift for Jake the dog. His family gave him a stem cell treatment that they hope will extend his life.
Jake is an 11-year-old yellow lab. He’s been part of the LeBlanc family since he was a puppy. Jake’s owner, Elizabeth LeBlanc, calls him her “first baby.” But then Mia and Aidan were born and at ages eight and five years old, they love to play with Jake.
When the LeBlanc’s noticed Jake was having trouble getting around they wanted to help. They tried medication, but say it didn’t work for very long. Then Mia saw a segment about a stem cell treatment for dogs on t.v. and asked if they could get it for Jake. The LeBlanc’s called their veterinarian and found out the Stanley Veterinary Clinic in Stanley, Kansas is the only place in the metro where they can do the entire procedure in house.
Dr. Les Pelfrey, D.V.M. explained the procedure.
“We’re going to collect about 20 grams of fat surgically and then we’re going to process it in our lab here in house then we’re going to reintroduce those stem cells after we activate them back into the affected joints,” said Dr. Les Pelfrey.
The procedure can cost $3000. The dog’s fatty tissue has to be sent off to a lab for the stem cells to be extracted. But at the Stanley Veterinary Clinic they can process the stem cells in their own lab, cutting the cost to $1800.00.
Jake’s arthritis is affecting his hips, knees, one elbow and one shoulder. Dr. Pelfrey made an incision and removed the fatty tissue from Jake. Then veterinary technician Stephanie Pierce took it to the lab to break it down, cook it and then spin it. The final product? Stem cells that were then re-injected into Jake’s joints to help him grow cartilage. Pierce says Jake will “act like a puppy again as far as moving around.”
The LeBlancs can’t wait to see the results.
“For 12 years he’s given us love and joy so we just want to give him a better quality of life,” LeBlanc said.
Jake will spend the night at the Stanley Veterinary Clinic. He should be able to head home tomorrow. Jake and the LeBlancs should notice results in the next few weeks.
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Dog Receives First-Ever Stem Cell Therapy in Kansas City
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Scarred Hearts Can Be Mended With Stem Cell Therapy
Posted: February 15, 2012 at 1:17 am
February 14, 2012, 3:17 PM EST
By Ryan Flinn
(Adds comment from researcher in 13th paragraph.)
Feb. 14 (Bloomberg) -- Stem cells grown from patients’ own cardiac tissue can heal damage once thought to be permanent after a heart attack, according to a study that suggests the experimental approach may one day help stave off heart failure.
In a trial of 25 heart-attack patients, 17 who got the stem cell treatment showed a 50 percent reduction in cardiac scar tissue compared with no improvement for the eight who received standard care. The results, from the first of three sets of clinical trials generally needed for regulatory approval, were published today in the medical journal Lancet.
“The findings in this paper are encouraging,” Deepak Srivastava, director of the San Francisco-based Gladstone Institute of Cardiovascular Disease, said in an interview. “There’s a dire need for new therapies for people with heart failure, it’s still the No. 1 cause of death in men and women.”
The study, by researchers from Cedars-Sinai Heart Institute in Los Angeles and Johns Hopkins University in Baltimore, tested the approach in patients who recently suffered a heart attack, with the goal that repairing the damage might help stave off failure. While patients getting the stem cells showed no more improvement in heart function than those who didn’t get the experimental therapy, the theory is that new tissue regenerated by the stem cells can strengthen the heart, said Eduardo Marban, the study’s lead author.
“What our trial was designed to do is to reverse the injury once it’s happened,” said Marban, director of Cedars- Sinai Heart Institute. “The quantitative outcome that we had in this paper is to shift patients from a high-risk group to a low- risk group.”
Minimally Invasive
The stem cells were implanted within five weeks after patients suffering heart attacks. Doctors removed heart tissue, about the size of half a raisin, using a minimally invasive procedure that involved a thin needle threaded through the veins. After cultivating the stem cells from the tissue, doctors reinserted them using a second minimally invasive procedure. Patients got 12.5 million cells to 25 million cells.
A year after the procedure, six patients in the stem cell group had serious side effects, including a heart attack, chest pain, a coronary bypass, implantation of a defibrillator, and two other events unrelated to the heart. One of patient’s side effects were possibly linked to the treatment, the study found.
While the main goal of the trial was to examine the safety of the procedure, the decrease in scar tissue in those treated merits a larger study that focuses on broader clinical outcomes, researchers said in the paper.
Heart Regeneration
“If we can regenerate the whole heart, then the patient would be completely normal,” Marban said. “We haven’t fulfilled that yet, but we’ve gotten rid of half of the injury, and that’s a good start.”
While the study resulted in patients having an increase in muscle mass and a shrinkage of scar size, the amount of blood flowing out of the heart, or the ejection fraction, wasn’t different between the control group and stem-cell therapy group. The measurement is important because poor blood flow deprives the body of oxygen and nutrients it needs to function properly, Srivastava said.
“The patients don’t have a functional benefit in this study,” said Srivastava, who wasn’t not involved in the trial.
The technology is being developed by closely held Capricor Inc., which will further test it in 200 patients for the second of three trials typically required for regulatory approval. Marban is a founder of the Los Angeles-based company and chairman of its scientific advisory board. His wife, Linda Marban, is also a founder and chief executive officer.
“We’d like to study patients who are much sicker and see if we can actually spare them early death, or the need for a heart transplant, or a device,” Eduardo Marban said.
--Editors: Angela Zimm, Andrew Pollack
#<184845.409373.2.1.99.7.25># -0- Feb/14/2012 17:13 GMT
To contact the reporter on this story: Ryan Flinn in San Francisco at rflinn@bloomberg.net
To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net
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Bone gives ‘some’ heart healing
Posted: February 15, 2012 at 1:17 am
14 February 2012 Last updated at 19:10 ET By James Gallagher Health and science reporter, BBC News
Bone marrow stem cell therapy offers "moderate improvement" to heart attack patients, according to a large UK review of clinical trials.
The analysis by the Cochrane Collaboration looked at 33 trials involving more than 1,700 patients.
It said longer-term studies were needed to see if the experimental therapy affected life expectancy.
The review comes a day after doctors reported the first case of using heart cells to heal heart attack damage.
If a patient survives a heart attack, dead heart muscle is replaced with scar tissue - leaving the patient weaker and possibly on a lifetime of medicine.
Researchers are beginning to show that taking cells from a heart, growing millions of new heart cells in the laboratory and pumping those back into the heart may reduce scar tissue and lead to new heart muscle.
Continue reading the main story “Start Quote
Stem cell therapy may also reduce the number of patients who later die or suffer from heart failure, but currently there is a lack of statistically significant evidence based on the small number of patients treated so far”
End Quote Dr Enca Martin-Rendon Lead researcher
However, the trials are at a very early stage and in only a handful of patients. Using a similar technique with cells taken from the bone marrow, which is a prime source of stem cells, has a much longer pedigree.
The report by Cochrane pooled the data from all 33 bone marrow trials which had taken place up to 2011.
It concluded that bone marrow therapy "may lead to a moderate long-term improvement" in heart function which "might be clinically very important".
Longer life uncertain
It said there was still no evidence of "any significant effect on mortality" in comparison with standard treatment. However, this may be due to the size of the studies and that patients were followed for a short period of time.
Lead author Dr Enca Martin-Rendon, from NHS Blood and Transplant at the John Radcliffe Hospital in Oxford, said: "This new treatment may lead to moderate improvement in heart function over standard treatments.
"Stem cell therapy may also reduce the number of patients who later die or suffer from heart failure, but currently there is a lack of statistically significant evidence based on the small number of patients treated so far."
Prof Anthony Mathur, from Barts and the London School of Medicine and Dentistry, is leading the largest ever trial of stem cells in heart attack patients.
It starts this year, however, he told the BBC that the results could come quite quickly. Three thousand patients across Europe will take part. They will be injected with stem cells five days after a heart attack and then followed for two years to see if the therapy affects life expectancy.
Prof Peter Weissberg, medical director at the British Heart Foundation, said: "This review reflects the consensus of opinion about these trials - cell therapy has a modestly beneficial effect.
"Despite that, no-one knows why, or even if, cell therapies will translate into better survival or sustained improvement in damaged hearts. It's much too early to judge the likely long-term benefits."
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Bone gives 'some' heart healing
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VistaGen Updates Pipeline of Stem Cell Technology-Based Drug Rescue Candidates
Posted: February 14, 2012 at 8:02 pm
SOUTH SAN FRANCISCO, CA--(Marketwire -02/14/12)- VistaGen Therapeutics, Inc. (OTC.BB: VSTA.OB - News) (OTCQB: VSTA.OB - News), a biotechnology company applying stem cell technology for drug rescue and cell therapy, has identified its initial Top 10 drug rescue candidates and plans to launch two formal drug rescue programs by the end of next quarter.
VistaGen's goal for each of its stem cell technology-based drug rescue programs is to generate and license a new, safer variant of a once-promising large market drug candidate previously discontinued by a pharmaceutical company no earlier than late-preclinical development.
"We are now at an advanced stage in our business model," said Shawn Singh, VistaGen's Chief Executive Officer. "After more than a decade of focused investment in pluripotent stem cell research and development, we are now at the threshold where game-changing science becomes therapeutically relevant to patients and commercially relevant to our shareholders. We have positioned our company and our stem cell technology platform to pursue multiple large market opportunities. We plan to launch two drug rescue programs by the end of the next quarter."
Over the past year, VistaGen, working with its network of strategic partners, identified over 525 once-promising new drug candidates that meet the Company's preliminary screening criteria for heart toxicity-focused drug rescue using CardioSafe 3D™, its human heart cell-based bioassay system. After internally narrowing the field to 35 compounds, VistaGen, working together with its external drug rescue advisors, including former senior pharmaceutical industry executives with drug safety and medicinal chemistry expertise, analyzed and carefully narrowed the group of 35 to the current Top 10.
About VistaGen Therapeutics
VistaGen is a biotechnology company applying human pluripotent stem cell technology for drug rescue and cell therapy. VistaGen's drug rescue activities combine its human pluripotent stem cell technology platform, Human Clinical Trials in a Test Tube™, with modern medicinal chemistry to generate new chemical variants of once-promising small-molecule drug candidates. These are once-promising drug candidates discontinued by pharmaceutical companies during development due to heart toxicity, despite positive efficacy data demonstrating their potential therapeutic and commercial benefits. VistaGen uses its pluripotent stem cell technology to generate early indications, or predictions, of how humans will ultimately respond to new drug candidates before they are ever tested in humans.
Additionally, VistaGen's oral small molecule prodrug candidate, AV-101 (4-Cl-KYN), is in Phase 1b development for treatment of neuropathic pain. Unlike other NMDA receptor antagonists developed previously, AV-101 readily crosses the blood-brain barrier and is then efficiently converted into 7-chlorokynurenic acid (7-Cl-KYNA), one of the most potent and specific glycineB site antagonists currently known, and has been shown to reduce seizures and excitotoxic neuronal death. Neuropathic pain, a serious and chronic condition causing pain after an injury or disease of the peripheral or central nervous system, affects approximately 1.8 million people in the U.S. alone. To date, VistaGen has been awarded over $8.5 million from the NIH for development of AV-101. The Company anticipates pursuing Phase 2 development for neuropathic pain and other neurological indications, including depression, epilepsy, and/or Parkinson's disease in the event it receives additional non-dilutive development grant funding from the NIH or private foundations.
Visit VistaGen at http://www.VistaGen.com, follow VistaGen at http://www.twitter.com/VistaGen or view VistaGen's Facebook page at http://www.facebook.com/VistaGen.
Cautionary Statement Regarding Forward Looking Statements
The statements in this press release that are not historical facts may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to the success of VistaGen's stem cell technology-based drug rescue activities, ongoing AV-101 clinical studies, its ability to enter into drug rescue collaborations and/or licensing arrangements with respect to one or more drug rescue variants, risks and uncertainties relating to the availability of substantial additional capital to support VistaGen's research, drug rescue, development and commercialization activities, and the success of its research and development plans and strategies, including those plans and strategies related to AV-101 and any drug rescue variant identified and developed by VistaGen. These and other risks and uncertainties are identified and described in more detail in VistaGen's filings with the Securities and Exchange Commission (SEC). These filings are available on the SEC's website at http://www.sec.gov. VistaGen undertakes no obligation to publicly update or revise any forward-looking statements.
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VistaGen Updates Pipeline of Stem Cell Technology-Based Drug Rescue Candidates
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Stem cell treatments change girl’s life
Posted: February 13, 2012 at 11:07 pm
PIEDMONT, Okla. -- Stem cell research is one of the newest and most exciting areas of study. Experts believe these tiny unwritten cells hold the keys to curing a number of diseases and debilitating injuries. But here in the U.S., stem cell research isn't moving fast enough for a growing number of families.
This is the story of an Oklahoma family that traveled to China for cutting-edge stem cell treatment not offered in the US.
Cora Beth Taylor walks a different road than most will ever travel.
Her journey is filled with obstacles, heartbreak and triumph.
Cora, William and Tate Taylor are triplets born premature.
The brothers have never shown any signs of prematurity.
But Cora, at about a year old, started falling behind developmentally.
By 18 months she had been diagnosed with Cerebral Palsy.
Cora has never had any cognitive delays.
She's a super-smart little gal but her muscles haven't developed properly.
It's devastating; they just won't cooperate.
Cora's parents, Kevin and Beth Taylor, have tried everything for their little girl; that is, everything available in the U.S.
Last year, Piedmont Schools raised the money to help the Taylors take Cora to China for treatment, close to $50,000.
Research hospitals in China are using stem cells from donor umbilical cord blood to treat children with Cerebral Palsy.
Beth Taylor says, "That was a difficult decision to make to take your child to a foreign country for medical treatments. Living in the US you feel like this is the best there is."
The Taylors spent 37 days in China.
Cora Beth had eight stem cell transfusions.
Through a spinal tap, doctors put the cells into her spinal column where they penetrate the blood-brain barrier and get to work.
Critics are quick to point out this area of regenerative medicine has largely unverified effectiveness. Results are often anecdotal and the FDA is a long way from approving this type of experimental treatment for America.
Though the Taylors are convinced and here's why.
Beth Taylor said, "Within the first couple of weeks we could see changes. We could see definite improvements in strength and balance."
Cora had never been able to do a sit-up in her life ever; she did her first in China.
Nine-year-old Cora remembers, "The thing that I was most happy about accomplishing was a sit up. Because I'd tried to do a sit up before going to China but I just couldn't do it."
Now, Cora Beth can do 20.
The most notable change has been Cora's walk.
This third-grader had never gone to school without her walker.
Today she walks the halls without it; she hasn't used it in months.
She recently competed in a beauty pageant in her hometown of Piedmont, without the help of her walker as well.
Cora says, "So, I'm really excited. I don't think there's anything that I couldn't accomplish."
Doctors say Cora’s stem cells will continue to mature over the next few years.
For her, there are many milestones ahead.
In the US, Duke University is studying stem cell treatments for children with Cerebral Palsy.
Right now they don't have FDA clearance to use donor stem-cells.
Experts say treatment similar to Cora Beth's Chinese therapy is years away in the U.S.
Posted in Cell Therapy
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Therapy targets leukemia stem cells
Posted: February 13, 2012 at 11:07 pm
Chronic myelogenous leukemia (CML) is a cancer of the white blood cells for which tyrosine kinase inhibitors are currently the first line of therapy. These drugs prolong survival, but disease recurrence is often seen after drug treatment is stopped. "Tyrosine kinase inhibitors do not eliminate leukemia stem cells, which remain a potential source of cancer recurrence," explains senior coauthor Dr. Ravi Bhatia from the City of Hope National Medical Center in Duarte, California. "CML patients need to take tyrosine kinase inhibitor treatment indefinitely, which carries a significant risk of toxicity, lack of compliance, drug resistance, relapse, and associated expense."
Strategies targeting leukemia stem cells are necessary to achieve a cure. Previous work has implicated the enzyme sirtuin 1 (SIRT1) in protecting stem cells from stress and in playing a role in leukemia, as well as other types of cancer. In the current study, Dr. Bhatia, coauthor Dr. WenYong Chen, first author Ling Li, and their colleagues investigated whether SIRT1 was involved in the survival and growth of CML stem cells. The researchers discovered that SIRT1 was overexpressed in CML stem cells and that inhibition of SIRT1selectively reduced the survival and growth of CML stem cells. Importantly, SIRT1 inhibition was associated with activation of the p53 tumor suppressor.
Taken together, the results reveal a specific mechanism that supports the survival of leukemia stem cells. "Our findings are important because they show that SIRT1-mediated inactivation of p53 contributes to CML leukemia stem cell survival and resistance to treatment with tyrosine kinase inhibitors," concludes Dr. Chen. "We suggest that SIRT1 inhibition is an attractive approach to selectively target leukemia stem cells that resist elimination by current treatments."
Provided by Cell Press (news : web)
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Therapy targets leukemia stem cells
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