Where do things stand with some players in the for-profit world of stem cell and cellular medicine companies? Here are a few brief news items with quick analysis. Mesoblast is dominating the news of late.
Mesoblast reported good news from its Phase II safety trial for its mesenchymal progenitor cell (MPC) product in patients with Type II Diabetes. There were no treatment-related adverse outcomes and as a bonus there were hints of efficacy.
Osiris Going in New Direction. Cellular medicine company Osiris has been in the news quite a lot lately. The latest is that CEO & President Randall Mills is stepping down after about 10 years as the company’s leader. Personal reasons were cited, but the move could reflect a change in direction for the company. About a month ago we all learned that Osiris had received an untitled letter from the FDA and a few weeks before that it sold off its stem cell portfolio to Mesoblast.
Celgene Partners with OncoMed on the cancer stem cell front. In a case of one plus one is probably more than two, Celgene shelled out big bucks to partner with cancer stem cell biotech OncoMed to team up against cancer stem cells. OncoMed has been on a roller coaster since its IPO, but has an interesting, promising product in Phase II trials in the Notch pathway inhibitor Demcizumab.
Japanese Regenerative Medicine Regulatory Change Creates Buzz. The Japanese government has implemented regulatory changes that could speed the development of regenerative medicine therapies. The changes interest Cell Med biotechs including Mesoblast:
Mesoblast chief executive and founder Professor Silviu Itescu told Inside Business the bills enable Japan’s government to approve new products conditionally, providing their safety is confirmed in clinical trials, even if their efficacy has not yet been verified.
There are concerns, however, that a lack of data on efficacy may expose more patients to new products that have little chance to help them.
Disclosure: I don’t own stock in and am not affiliated with any of the companies mentioned above.
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