Stem Cell Treatments

Health Canada approves Osiris’ Prochymal to treat acute GvHD in children

Osiris Therapeutics Inc. (NASDAQ: OSIR) announced today it has received market authorization from Health Canada to market its stem cell therapy Prochymal (remestemcel-L), for the treatment of acute graft-vs-host disease (GvHD) in children. The historic decision marks the world’s first regulatory approval of a manufactured stem cell product and the first therapy approved for GvHD a devastating complication of bone marrow transplantation that kills up to 80 percent of children affected, many within just weeks of diagnosis.

“I am very proud of the leadership role Canada has taken in advancing stem cell therapy and particularly gratified that this historic decision benefits children who would otherwise have little hope,” said Andrew Daly, M.D., Clinical Associate Professor, Department of Medicine and Oncology at the University of Calgary, Canada and Principal Investigator in the phase 3 clinical program for Prochymal. “As a result of Health Canada’s comprehensive review, physicians now have an off-the-shelf stem cell therapy in their arsenal to fight GvHD. Much like the introduction of antibiotics in the late 1920′s, with stem cells we have now officially taken the first step into this new paradigm of medicine.”

Prochymal was authorized under Health Canada’s Notice of Compliance with conditions (NOC/c) pathway, which provides access to therapeutic products that address unmet medical conditions and which have demonstrated a favorable risk/benefit profile in clinical trials. Under the NOC/c pathway, the sponsor must agree to carry out confirmatory clinical testing.

“Today is not only a great day for Osiris, but for everyone involved in the responsible development of stem cell therapies,” said C. Randal Mills, Ph.D., President and Chief Executive Officer of Osiris. “Most importantly, today is a great day for children and their families who bravely face this horrific disease. While today marks the first approval of a stem cell drug, now that the door has been opened, it will surely not be the last.”

Health Canadas authorization was made following the recommendation of an independent expert advisory panel, commissioned to evaluate Prochymal’s safety and efficacy. In Canada, Prochymal is now authorized for the management of acute GvHD in children who fail to respond to steroids. The approval was based on the results from clinical studies evaluating Prochymal in patients with severe refractory acute GvHD. Prochymal demonstrated a clinically meaningful response at 28 days post initiation of therapy in 61-64 percent of patients treated. Furthermore, treatment with Prochymal resulted in a statistically significant improvement in survival when compared to a historical control population of pediatric patients with refractory GvHD (p=0.028). The survival benefit was most pronounced in patients with the most severe forms of GvHD. As a condition of approval, the clinical benefit of Prochymal will be further evaluated in a case matched confirmatory trial and all patients receiving Prochymal will be encouraged to participate in a registry that will monitor the long-term effects of the therapy.

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Health Canada approves Osiris’ Prochymal to treat acute GvHD in children

State Awards Stem Cell Research Funding

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Posted May 17, 2012

Courtesy of MDBIZNes

By Nick Sohr, Managing Editor, MDBIZNews

Maryland approved state funding for 40 researchers studying human stem cells and their applications in treating a wide range of diseases and other medical conditions.

The awards, approved Thursday by the Maryland Technology Development Corporation, will be paid from the Maryland Stem Cell Research Fund’s $12.4 million budget for fiscal 2012.

The Maryland Stem Cell Research Commission recommended the 40 winners after whittling down the list of 179 applicants seeking funding through the program.

“These projects address a diverse array of debilitating and costly diseases and conditions, some of which are traditionally underfunded,” said Margaret Conn Himelfarb, chairwoman of the commission. “Maryland’s investment in cutting-edge stem cell research continues to advance the field and strengthens our state’s national leadership position in the life sciences.”

This year, the commission focused on regenerative medicine proposals, selecting research that targets sickle cell anemia, schizophrenia, type 1 diabetes, nerve injury, Parkinson’s disease, Crohn’s disease, multiple sclerosis, heart disease, osteoarthritis, and Lou Gehrig’s disease, among others.

The commission will also fund a Maryland researcher working with counterparts funded by California Institute of Regenerative Medicine. They are studying stem cell differentiation and bone repair.

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State Awards Stem Cell Research Funding

Cell Signaling Breakthrough May Help Melanoma Treatment

Featured Article Main Category: Melanoma / Skin Cancer Also Included In: Dermatology;Cancer / Oncology Article Date: 16 May 2012 – 10:00 PDT

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A key discovery made by scientists from the Texas University Health Science Center at Houston (UTHealth) Medical School reveals that cell signaling plays an important role in the fight against melanoma and various other fast-spreading tumors.

The study is published online ahead of the June 5 edition of Current Biology.

About 9,000 people die each year from melanoma (skin cancer), according to the American Cancer Society. The researchers have now discovered the reason as to why BRaf inhibitors, which are frequently used for the treatment of skin cancers do not always work, and most significantly, how these drugs can possibly speed up the growth of cancer in certain patient populations.

Senior author John Hancock, M.B, B.Chir, Ph.D., a John S. Dunn Distinguished University Chair in Physiology and Medicine and chairman of the Department of Integrative Biology and Pharmacology, who is also interim director of the Brown Foundation Institute of Molecular Medicine for the Prevention of Human Diseases at the UTHealth Medical School declared:

A chain of proteins that forms a signaling pathway transmits growth signals from a cell’s surface to the nucleus, whilst the command for dividing cells in order generate new cells is relayed by a chain of four proteins, namely RAS, BRaf, MEK and ERK. This pathway is shared by all cells and is generally very effective, yet difficulties occur when one of the first proteins in the chain is mutated, as both proteins lock the pathway in the ‘on’ position.

BRaf inhibitors are drugs that block the signaling from the second protein, and are successful in treating melanomas with mutant BRaf proteins. However, so far, there are no inhibitors available that can block the first protein (RAS). The team conducted in vivo studies to explore what happens when BRaf inhibitors are applied to human cancer tissues with Ras mutations.

Kwang-jin Cho, Ph.D., the study’s lead author and research fellow at the UTHealth Medical School declared:

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Cell Signaling Breakthrough May Help Melanoma Treatment

Behavior problems & cell phones linked?

NEW HAVEN, Conn., (WPRI) – A new study links radiation from cell phones to behavioral problems in the offspring of pregnant mice.

The study does not say whether or not cell phone radiation may also be dangerous for pregnant women.

A professor at the Yale School of Medicine in New Haven, Dr. Hugh Taylor, led a team of researchers who studied pregnant mice and their babies. They wanted to find out what happens to mice whose mothers were exposed during pregnancy to electro magnetic radiation from a cell phone.

We had a control (group) that had a cell phone on top of the cage that was turned off, and the experimental group had a cell phone on top of the cage that was turned on, Dr. Taylor explained.

Researchers learned that the offspring of the pregnant mice exposed to radiation developed behavioral problems. They also learned that the longer the mice were exposed to radiation, the more problems they developed.

They were more hyperactive. They were running around the cage a lot more than the mice that weren’t exposed to cell phones, said Dr. Taylor.

Dr. Taylor and his team of researchers did not learn whether or not the radiation that hurt pregnant mice would hurt pregnant women.

Dr. Taylor characterized the results as a warning that we should be careful and investigate it further. It’s not saying this definitely occurs in women or humans, but it may.

Yale’s researchers have advised pregnant women to keep their cell phones away from their bodies, especially their abdomens, because the radiation weakens dramatically after only small distances. For example, moving a cell phone four feet away makes the radiation it emits 16 times weaker. At eight feet away, its 64 times weaker, and so on.

The researchers also want pregnant women to know that cell phones emit radiation when they’re turned on, regardless of whether anyone is talking.

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Behavior problems & cell phones linked?

New Clinical Data Highlighting Foundation Medicine’s Comprehensive Cancer Genomic Profile to be Presented at 2012 ASCO …

CAMBRIDGE, Mass.–(BUSINESS WIRE)–

Foundation Medicine, Inc., a molecular information company that brings comprehensive cancer genomic analysis to routine clinical care, today announced that new clinical data highlighting the companys comprehensive cancer genomic profile and next-generation sequencing approach in clinical oncology will be presented at the 2012 Annual Meeting of the American Society for Clinical Oncology (ASCO) being held June 1-5, 2012 in Chicago.

The data to be presented at ASCO support Foundation Medicines deep sequencing approach to simultaneously detect all classes of genomic alterations across hundreds of genes known to be related to cancer, said Michael J. Pellini, M.D., president and chief executive officer, Foundation Medicine. In our clinical experience abstract, this approach detected actionable alterations those associated with available targeted treatments or ongoing clinical trials for 74% of tumor samples in the study. Foundation Medicines test has also been shown to identify novel genomic alterations in multiple tumor types, including potentially druggable gene fusions. The combined evidence presented in these studies suggests that fully informative genomic profiling can now become a routine component of cancer patient care.

The schedule for Foundation Medicines oral presentation is as follows:

Date & Time:

Session:

Abstract Number:

Title:

Discovery of recurrent KIF5B-RET fusions and other targetable alterations from clinical NSCLC specimens.

Location:

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New Clinical Data Highlighting Foundation Medicine’s Comprehensive Cancer Genomic Profile to be Presented at 2012 ASCO …

Aastrom Biosciences to Present at World Stem Cells & Regenerative Medicine Congress

ANN ARBOR, Mich., May 17, 2012 (GLOBE NEWSWIRE) — Aastrom Biosciences, Inc. (Nasdaq:ASTM – News), the leading developer of patient-specific expanded multicellular therapies for the treatment of severe chronic cardiovascular diseases, today announced that company president and CEO Tim Mayleben will be presenting at the World Stem Cells & Regenerative Medicine Congress at the Park Plaza hotel in London, UK. The presentation entitled “Phase 3 Development of a Cellular Therapy Product” will take place on Monday, May 21, 2012 at 4:40 pm (BST).

The Aastrom presentation will cover the benefits of a special protocol assessment and offer insights on achieving manufacturing readiness. The presentation will also address the role of clinicians and patients in the Phase 3 development process.

About Aastrom Biosciences

Aastrom Biosciences is the leader in developing patient-specific, expanded multicellular therapies for use in the treatment of patients with severe, chronic cardiovascular diseases. The company’s proprietary cell-processing technology enables the manufacture of ixmyelocel-T, a patient-specific multicellular therapy expanded from a patient’s own bone marrow and delivered directly to damaged tissues. Aastrom has advanced ixmyelocel-T into late-stage clinical development, including a Phase 3 clinical program to study patients with critical limb ischemia and a planned Phase 2b clinical trial in patients with ischemic dilated cardiomyopathy. For more information, please visit Aastrom’s website at www.aastrom.com. For more information on the pivotal REVIVE Phase 3 clinical trial, please visit the trial website at www.revivecli.com.

The Aastrom Biosciences, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=3663

This document contains forward-looking statements, including, without limitation, statements concerning clinical trial plans and progress, objectives and expectations, clinical activity timing, intended product development, the performance and contribution of certain individuals and expected timing of collecting and analyzing treatment data, all of which involve certain risks and uncertainties. These statements are often, but are not always, made through the use of words or phrases such as “anticipates,” “intends,” “estimates,” “plans,” “expects,” “we believe,” “we intend,” and similar words or phrases, or future or conditional verbs such as “will,” “would,” “should,” “potential,” “could,” “may,” or similar expressions. Actual results may differ significantly from the expectations contained in the forward-looking statements. Among the factors that may result in differences are the inherent uncertainties associated with clinical trial and product development activities, regulatory approval requirements, competitive developments, and the availability of resources and the allocation of resources among different potential uses. These and other significant factors are discussed in greater detail in Aastrom’s Annual or Transition Report on Form 10-K or 10-K/T, Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. These forward-looking statements reflect management’s current views and Aastrom does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this release except as required by law.

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Aastrom Biosciences to Present at World Stem Cells & Regenerative Medicine Congress

Osiris stem-cell therapy wins Canadian approval

BOSTON (MarketWatch) — Shares of Osiris Therapeutics jumped 14% to $5.60 in after-hours trading Thursday on news that Canadian regulators have approved its product Prochymal for the treatment of acute graft-vs-host disease, or GVHD, in children. GVHD is a life-threatening complication associated with such procedures as bone-marrow transplantation. Osiris added it was the world's first …

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Osiris stem-cell therapy wins Canadian approval

Osiris stem cell therapy approved in Canada

Osiris Therapeutics Inc. said Thursday that Canadian regulators approved its stem cell therapy Prochymal, which is intended to treat a deadly side effect of bone marrow transplants.

Stem cell donors needed for former schools superintendent

Friends of John Glaser, the former superintendent of the Napa Valley Unified School District, are seeking stem cell donors to help with his medical treatment.

Glaser is dealing with two cancers: Multiple myeloma and leukemia. He is in need of a second stem cell transplant, his supporters said.

Potential donors can request a cheek swab kit online, and mail the swab in to be registered in the worldwide pool of stem cell donors. To qualify for the registry, a person needs to be between the ages of 18 and 60 and in good health.

Those who match Glaser or another transplant patient would be asked to go to a nearby lab for a blood draw and have their blood cells further analyzed.

People who are chosen as donors would then return to the lab for a blood donation, where the stem cells would be extracted and their blood would be returned to them. The process takes three to four hours.

For more information on how to donate stem cells, visit marrow.org.

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Stem cell donors needed for former schools superintendent

Two stem cell therapies from Cytomedix to start trials; stroke study expands

When regenerative medicine firm Cytomedix (OTC:CMXI) acquired biotechnology company Aldagen, the stem cell-based stroke treatment in clinical trials was the centerpiece of the all stock deal.

Cytomedix is now making moves to develop other stem cell treatments from its Aldagen acquisition. Two more clinical trials will start later this year, CEO Martin Rosendale told analysts on a conference call to discuss first-quarter financial results. Rosendale wouldnt identify the indications that will be studied, and said only that they will be announced this summer: one for an arterial disease and the other a neurological condition.

Cytomedixs goal is to ultimately find large pharmaceutical partners to commercialize these treatments. These additional clinical studies dont represent those kinds of partnerships. Rosendale said there are two facilities that will conduct investigator-led clinical trials. But those trials will be funded by outside sources, not by Cytomedix.

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Two stem cell therapies from Cytomedix to start trials; stroke study expands