STEM CELL STOCKS

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Stem cell therapy may be boon for Athersys

Pfizer, analysts see big potential for MultiStem

By CHUCK SODER

4:30 am, June 7, 2010
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The scientists at pharmaceutical giant Pfizer Inc. aren't the only ones who have confidence in Athersys Inc.'s adult stem cell therapy.

Three stock analysts who spoke with Crain's Cleveland Business said they think the Cleveland biotech company's MultiStem therapy one day might help patients with various medical maladies — and that it might be better than a competitor's similar product that has received a lot more attention.

That competitor, Osiris Therapeutics Inc. of Baltimore, in November 2008 struck a deal that could be worth as much as $1.25 billion with pharmaceutical giant Genzyme Corp. The deal gave Genzyme rights to commercialize two of Osiris' adult stem cell therapies in markets outside the United States and Canada.

Osiris has an edge over Athersys in that the Baltimore company's lead product, Prochymal, already is deep into Phase III clinical trials. By comparison, Athersys has yet to complete a Phase I trial of MultiStem. And though Athersys has its own deal with a big-name pharmaceutical company — Pfizer in December said it would pay Athersys $6 million up front and up to $105 million to help it commercialize the use of MultiStem for inflammatory bowel disease — that deal is smaller than Osiris' in terms of dollars.

The securities analysts who spoke with Crain's, however, say Athersys has some advantages of its own.

Dr. Duane Nash says MultiStem looks “very promising” and he doesn't even cover Athersys: He follows Osiris, which was founded in Cleveland but moved to Baltimore in 1994.

MultiStem's main advantage is that it should be cheaper to produce, said Dr. Nash, vice president for equity research at the San Francisco office of Wedbush Securities Inc. Dr. Nash cited Athersys' claim that a single donor could provide enough stem cells to produce hundreds of thousands if not millions of doses. Osiris has gone only so far as to say that “thousands” of doses of Prochymal could be produced from a single donor's cells.

Dr. Nash also noted that the multipotent adult progenitor cells that form the basis of MultiStem could prove to have broader capabilities than the mesenchymal stem cells Osiris uses, though he added that MultiStem's flexibility might make the therapy harder to control when treating patients for various conditions.


Imagine that

Jonathan Aschoff, who covers Athersys for Brean Murray, Carret & Co., was similarly optimistic about MultiStem for the same reasons. Dr. Aschoff added that MultiStem appears to be safe and has performed well in animal trials, but now Athersys needs to prove it works.

“I'm very comfortable with the safety. Now all we need is the efficacy,” said Dr. Aschoff, senior vice president of equity research at the firm's New York office.

Stephen Brozak, president of San Diego-based WBB Securities LLC, was even more enthusiastic about MultiStem's prospects. He lauded the therapy's safety and its scalability, and he added that few drug companies understand how their products work as well as Athersys understands the mechanisms behind MultiStem.

The potential for MultiStem's use in treating so many illnesses makes it all the more valuable, said Mr. Brozak, who noted that he owns no shares of the company.

“The imagination is the only thing that contains them,” he said.

MultiStem consists of adult stem cells — taken from human bone marrow — that can sense bodily injury and can make proteins in response. Those proteins can reduce inflammation, form new blood vessels and protect existing tissue.

Now Athersys, which has about 40 employees, is working to prove that the therapy will work in humans. The company is testing MultiStem in people whose bodies are rejecting bone marrow transplants, and it has finished enrolling patients for another clinical trial that will test the therapy's ability to help them recover from heart attacks.


Gaining in credibility

Athersys has won federal approval to test MultiStem in stroke patients, and it's working with Pfizer to prepare MultiStem for testing in patients with inflammatory bowel disease.

The Pfizer partnership has done a lot to boost investor confidence in Athersys, said CEO Gil Van Bokkelen.

“That (partnership) enabled us to achieve a certain amount of credibility,” Dr. Van Bokkelen said.

After hovering at about $1 per share, Athersys' stock price more than quadrupled a few days after the partnership was announced but has since lost some steam. The stock's price stood at $2.94 when markets closed last Thursday, June 3.

Ruth McKernan, head of Pfizer's regenerative medicine unit, was not available to comment for this story. However, during a series of panel discussions that Athersys organized last month to educate investors about MultiStem as well as obesity drugs it is developing, she described Athersys as “a cornerstone” of Pfizer's adult stem cell strategy. Dr. McKernan added that their collaboration might not end with work on inflammatory bowel disease.

“Obviously we are interested in discussing other indications, too,” she said during the event.

Other scientists and doctors at the event praised MultiStem's potential as well. Plus, Pfizer isn't Athersys' only drug partner: The company since 2006 has been working with Angiotech Pharmaceuticals Inc. of Vancouver to develop and test the use of MultiStem on heart attack patients.


Potential job generator

It will take Athersys years to win regulatory approval for MultiStem, but once it gets approval to use the therapy on one medical condition, it should have an easier time winning approval for the others, Dr. Van Bokkelen said. Even starting clinical trials for different uses of MultiStem became easier after Athersys won approval to begin the first one, he said.

“The amount of leverage you can eventually get ... is truly astounding,” Dr. Van Bokkelen said.

As part of Athersys' partnership with Pfizer, the big drug company is covering costs related to development and clinical trials of MultiStem for inflammatory bowel disease on top of its cash payments, which will increase as Athersys hits development, regulatory and commercial milestones. Should the product reach the market, Pfizer would pay Athersys royalties on its sales for that condition, though Athersys could elect to co-develop the drug with Pfizer.

Athersys expects that partner companies such as Pfizer will handle sales and marketing for most uses of MultiStem as they win regulatory approval. Athersys currently contracts out manufacturing of the stem cells, but it eventually plans to bring that capability in house, said chief operating officer B.J. Lehmann. He estimated that a plant making MultiStem for a single condition might employ 50 to 100 people.

“If you were doing several large disease areas, you might have several of those,” Mr. Lehmann said.

[dlry]

These researchers are trying to get the controversy to end so cures can begin....


Tufts University
Rapping stem cell researcher
by Carolyn Y. Johnson June 9, 2010 04:22 PM

"It's about diagnoses of all kinds of interesting diseases," Garlick said. "It’s inspirational; it’s all about the learning. I have a deep reverence and respect for the content, but I think we all need to be able to think about learning in a new light."

http://tinyurl.com/36a6zh8

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Bone Marrow Stem Cells Reverse Sickle Cell Disease

June 13th, 2010

But a new procedure developed by the National Institute of Health (NIH) and Johns Hopkins University has successfully transplanted marrow to adults, reversing the disorder in 9 out of 10 patients. The new treatment uses significantly less radiation (about one fourth) to kill the patient’s existent marrow, combined with the immunosuppressant drug Sirolimus to reduce the likelihood of transplant rejection. By allowing more of the patient’s own marrow to remain, recovery from the transplant is faster and healthier (patients could previously spend months in germ-free isolation while their immune systems recovered). Thirty months after the transplant, the nine patients with successful transplants are healthy and show no side effects.

http://tinyurl.com/36gb4xs

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Athersys and CSCRM Receive Grant Funding to Support Research Into Novel Stem Cell Treatment of Spinal Cord Injury

CLEVELAND, Jun 25, 2010 (GlobeNewswire via COMTEX) -- Athersys, Inc. /quotes/comstock/15*!athx/quotes/nls/athx (ATHX 3.20, +0.04, +1.27%) and its collaborators, including the Center for Stem Cell and Regenerative Medicine (CSCRM) and Case Western Reserve University (CWRU), announced today that they have been awarded $1 million through the Ohio Third Frontier Biomedical Program to support research into the treatment of spinal cord injury (SCI) with MultiStem(R), Athersys' proprietary stem cell product candidate. The project is intended to advance preclinical and translational research involving the use of MultiStem as a treatment for damage associated with SCI.

http://tinyurl.com/2593qxv

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Stem cell transplants stalled blindness in rats

Dr. Stephen Huhn, head of the Central Nervous System research program at StemCells Inc, said the cells are adult neural stem cells. He said they are multipotent, meaning they can morph into different types of nerve cells.

The company has already tested the treatment in a study of six patients with Batten's disease, a fatal inherited disorder of the nervous system.

"Having a cell that has already entered clinical testing that has been well tolerated at very high doses in the brain gives us a lot of confidence about exploring the same type of strategy in the eye," Huhn said.

Read more: http://tinyurl.com/248bne4


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This will be a growth industry....


Stem Cell Payoff
UConn Spinoff Closing In On Osteoarthritis Therapy

For now, Dealy is taking it one step at a time and focusing on advancing her findings.

Her research centers on converting human embryonic stem cells, which have the ability to become any cell type in the body, into cartilage cells.

Cartilage is the tough elastic tissue that provides a smooth gliding surface for joints. As it breaks down over time, cartilage doesn’t have the ability to repair itself, leading to painful conditions like osteoarthritis.

Researchers have tried to engineer replacement cartilage tissue using various techniques, Dealy said, but most are costly and may not provide a long-term fix.

Using stem cells to repair damaged cartilage is seen as an ideal method because the cells have an unlimited capacity for self renewal.

James Heym, the senior director of life science ventures for the UConn R&D Corp., said there are a growing number of pharmaceutical companies, like Pfizer and GlaxoSmithKline, that are interested in investing in stem cell therapy treatments.

By partnering with larger companies, Chondrogenics would be able to leverage their partner’s deep pockets and scientific expertise, two key elements in eventually being able to commercialize Dealy’s research, said Heym who has 25 years experience in pharmaceutical R&D at Pfizer, and has been involved with the successful discovery and development of several drugs.

http://www.hartfordbusiness.com/news14102.html


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Awesome things to come......


Growing Body Parts

July 25, 2010

Morley Safer reports on the emerging technology of growing body parts from human cells taken directly from patients, providing new hope for amputees and patients on organ-transplant lists.

http://tinyurl.com/2wad9a6


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Why don't they let this guy help people? Maybe soon? Imagine the results if they funded him like the TBTF'S

Get ready....


Stem Cell Rock Star

UC Irvine’s Hans Keirstead is a charismatic, tradition-bending, action-figure of a researcher who not only wants to heal the sick, but change the way academic scientists do business. Is the world ready for him?
By Patrick J. Kiger

Sci-fi movies and TV sitcoms have conditioned us to envision a scary smart, paradigm-shifting, scientific genius as a pale, distracted-looking guy with taped-up glasses, who speaks in an incomprehensible technical argot and exudes a cracklingly tense, impatient ambience, like a human Tesla coil about to spark the gap. Meeting Hans Keirstead is a shock of a different sort.

The UC Irvine stem cell researcher who startled the world by enabling paralyzed rats to walk—and aims someday soon to do the same for humans—is in his second-floor office at the Gillespie Neuroscience Research Facility, where the afternoon sun streaming through the window accentuates his tanned, finely chiseled features and the highlights of his lush mane.

At 43, the Canadian-born Keirstead, who was lured to UC Irvine in 2000 from the University of British Columbia by the promise of funding for a world-class facility, looks less like a neurobiologist and one of the fastest-rising stars of the scientific world than he does a youthful clone of Eagles drummer Don Henley. You half-expect him to embark on a hockey-arena tour this fall. Instead, he’s working with Geron, a Northern California biotech company, to launch the first federally approved clinical trial of a stem cell treatment for humans with spinal cord injuries, called GRNOPC1, based on his discoveries at UC Irvine. And instead of a Grammy, the gleaming trophy sitting nonchalantly on the edge of his desk—between framed photos of Keirstead riding a motorcycle and posed alongside his personal helicopter—is a plaque he recently received from the National Institutes of Health in Bethesda, Md.

“I don’t mean to brag,” Keirstead says, with the sort of shaken-not-stirred serenity that makes you believe he really means it, “but I just got back from the NIH, where I received this. The reason I love it so much, and that I’m so honored, is that it’s an endorsement by the think-tank scientific institute in America. This is the NIH saying, ‘Hans, you’re on the right track.’ And I can’t tell you how appreciative I am of that. Because one does experience a lot of antagonism from people who don’t understand the corporate realm and the priorities. People think I’ve made millions from the Geron deal, but I didn’t take a cent.

http://tinyurl.com/2fzh9d8


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Stem cells coaxed to rebuild bone

The experiments show that it should one day be possible to replace a human hip or knee with a joint grown naturally inside the body using the patient's own stem cells.

"This is the first time an entire joint surface was regenerated with return of functions including weight bearing and locomotion," lead researcher Jeremy Mao, a professor at Columbia University Medical Center, said in a statement.

http://tinyurl.com/39xzkgg


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Let's hope they get positive results immediately...


Geron to Proceed with First Human Clinical Trial of Embryonic Stem Cell-Based Therapy

Geron to Study GRNOPC1 in Patients with Acute Spinal Cord Injury


Press Release Source: Geron Corporation On Friday July 30, 2010, 7:30 am EDT

MENLO PARK, Calif.--(BUSINESS WIRE)--Geron Corporation (Nasdaq:GERN - News) announced today that the U.S. Food and Drug Administration (FDA) has notified the company that the clinical hold placed on Geron’s Investigational New Drug (IND) application has been lifted and the company’s Phase I clinical trial of GRNOPC1 in patients with acute spinal cord injury may proceed.

The FDA notification enables Geron to move forward with the world’s first clinical trial of a human embryonic stem cell (hESC)-based therapy in man. The Phase I multi-center trial is designed to establish the safety of GRNOPC1 in patients with “complete” American Spinal Injury Association (ASIA) Impairment Scale grade A subacute thoracic spinal cord injuries.

“We are pleased with the FDA’s decision to allow our planned clinical trial of GRNOPC1 in spinal cord injury to proceed,” said Thomas B. Okarma, Ph.D., M.D., Geron’s president and CEO. “Our goals for the application of GRNOPC1 in subacute spinal cord injury are unchanged – to achieve restoration of spinal cord function by the injection of hESC-derived oligodendrocyte progenitor cells directly into the lesion site of the patient’s injured spinal cord. Additionally, we are now formally exploring the utility of GRNOPC1 in other degenerative CNS disorders including Alzheimer’s, multiple sclerosis and Canavan disease.”

http://tinyurl.com/2e5of2c


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