Key Developments: Osiris Therapeutics Inc (OSIR.W)
10.87USD
21 May 2013
$-0.44 (-3.89%)
$11.31
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Latest Key Developments (Source: Significant Developments)
Osiris Therapeutics Inc Announces Conclusion Of Collaboration With Sanofi SA's Genzyme
Osiris Therapeutics Inc announced the conclusion of its collaboration with Genzyme, a Sanofi SA company. As the Collaboration Agreement is now ended, all rights to Prochymal and Chondrogen worldwide revert back to Osiris. Osiris is now free to commercialize or enter into commercialization agreements for Prochymal and Chondrogen with other parties without limitation. Both parties have agreed to an orderly conclusion of the collaboration, with no further financial responsibilities for either party, and an amicable end to their relationship. Full Article
Osiris Therapeutics, Inc. Announces Interim One Year Results From Clinical Trial Evaluating Prochymal
Osiris Therapeutics, Inc. announced interim one-year results from its groundbreaking clinical trial evaluating Prochymal(remestemcel-L) for the treatment of patients experiencing first-time acute myocardial infarction. The trial is the study of allogeneic or off-the-shelf stem cells ever conducted in heart attack patients. A total of 220 patients were given a single infusion of either Prochymal or placebo through a standard intravenous line within seven days of an acute heart attack. Cardiac MRI assessments were conducted for six months following infarct to evaluate cardiac remodeling. Patients receiving Prochymal had significantly less cardiac hypertrophy, as measured by cardiac MRI, compared to patients receiving placebo (p<0.05). Patients treated with Prochymal also experienced significantly less stress-induced ventricular arrhythmia (p<0.05). Cardiac hypertrophy and ventricular arrhythmia are indicators of pathological remodeling following heart injury and provide insight into the mechanism by which mesenchymal stem cells attenuate heart injury following a myocardial infarction. The mechanistic data is complemented by clinical data showing treatment with Prochymal resulted in a statistically reduction in heart failure. The trial also demonstrated that treatment with Prochymal was safe. There were no infusional toxicities observed in patients receiving Prochymal. Serious adverse events occurred with equal frequency in both treatment groups (31.8%). Full Article
Osiris Therapeutics, Inc. Receives Second Approval for Life-Saving Stem Cell Drug; Prochymal Granted Marketing Consent By New Zealand
Osiris Therapeutics, Inc. announced that it has received consent from New Zealand to market its first-in-class stem cell therapy Prochymal (remestemcel-L), for the treatment of acute graft-vs-host disease (GvHD) in children. Osiris submitted a New Medicine Application (NMA) to Medsafe (New Zealand's medical regulatory agency) in May of 2011, and was granted Priority Review in June of 2011. Priority review provides expedited review for new drugs which offer a significant clinical advantage over current treatment options. Prochymal was granted provisional consent under Section 23 of the Medicines Act 1981. Clinical trials have shown that Prochymal is able to induce an objective, clinically meaningful response in 61-64% of children with GvHD that is otherwise refractory to treatment. Furthermore, treatment response with Prochymal resulted in a statistically significant improvement in survival. It is expected that Prochymal will be commercially available in New Zealand later this year. Full Article
Osiris Therapeutics, Inc. Shares Rose On Nod For Wound Treatment Reimbursement-Reuters
Reuters reported that shares of Osiris Therapeutics, Inc. rose 15% on May 30, 2012, after U.S. health regulators said the stem cell technology company's wound treatment was eligible for reimbursement when used in hospitals in out-patient settings or in ambulances. The Center for Medicare & Medicaid Services also cleared the pathway for a permanent reimbursement code for Grafix, Osiris's wound-care matrix containing stem cells, on May 29, 2012. A permanent code makes reimbursement for the treatment faster and easier, thus increasing the chances of a physician prescribing it. Osiris said if the permanent reimbursement code for Grafix was approved, it could become effective from January next year. Full Article
Osiris Therapeutics, Inc. Receives Marketing Clearance From Health Canada For Prochymal
Osiris Therapeutics, Inc. announced that 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. 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. Full Article
Osiris Therapeutics, Inc. Provides Update On Groundbreaking Stem Cell Trial For Type 1 Diabetes
Osiris Therapeutics, Inc. provided an update on its Phase 2 trial evaluating Prochymal, a formulation of adult mesenchymal stem cells (MSCs), in patients with newly diagnosed type 1 diabetes. This first-of-its kind trial, conducted in partnership with JDRF, is testing MSCs from unrelated adult donors in 63 pediatric and adult patients to assess the safety of MSCs in this population and whether the treatment shows signs of slowing progression of the disease. Participants were randomly assigned to receive either Prochymal or placebo, and both the physicians and patients remain blinded as to which patients received stem cells. The interim assessment at one year showed that systemic infusions of Prochymal were well-tolerated in this unique population. There were no differences in adverse event rates between the Prochymal and placebo groups. Importantly, no patients experienced a reaction to the infusions despite the cells being unrelated to the recipient, unmatched, and used without immunosuppression. No significant differences in the rates of disease progression, as measured by stimulated C-peptide levels at the one year time point, have been observed. However there was a trend towards fewer hypoglycemic events for patients treated with Prochymal as compared to controls. The patients will be followed for another year (for a total of two years), after which time a complete analysis of the data will be conducted. Full Article
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