Posted on December 2nd, 2014
by Robin Smith
We are particularly encouraged by the results of our PreSERVE AMI trial both from our own reading of the initial results as well as from third-party feedback we received from cardiologists in the field when the results were presented at the American Heart Association’s Scientific Sessions on November 17th as well as from Dr. Timothy Henry, Director of Cardiology at the Cedars-Sinai Heart Institute and an internationally recognized expert in the treatment of patients with refractory angina and acute myocardial infarction, with a focus on stem cell therapies.
We feel encouraged by these initial results, and are excited to see evidence that the potential treatment both preserves heart muscle function and reduces clinically meaningful adverse events. Specifically, as mentioned previously, we saw:
We feel these initial results are particularly important, as they are consistent with FDA guidance that mortality and major adverse cardiac events (MACE) are the appropriate approvable endpoints to determine efficacy of a cellular therapy for cardiac disease as opposed to imaging endpoints, and that concern over the trial showing no meaningful difference in perfusion by SPECT should detract neither from the clinical relevance of these results nor the potential value of this therapy.
We believe the market response does not correlate with the views expressed by the thoughts leaders in this field and as such we will continue to educate the market. To that end, NeoStem held a webcast event, which you can view the recording of here, with Dr. Henry, a key opinion leader (KOL) in the field who was an investigator in the PreSERVE AMI study, on December 1st. We hope that by hearing the voices of KOLs in the development of cell therapies for cardiac disease, the public can come to better understand the results and come to their own conclusions about the potential value of this therapy based on the clinically relevant facts.
Furthermore, members of management and the Board of Directors of the company continue to show their support of the company through purchases of NeoStem stock of $267,000 in the period from November 17 through December 1.
We have further explained the clinical trial’s initial results in press releases, blog posts, and a conference call over the past two weeks. These items are collected here:
Forward Looking Statements
This blog contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management's current expectations, as of the date of this blog, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the successful execution of the Company's business strategy, the Company's ability to develop and grow its business, the successful development of cellular therapies with respect to the Company's research and development and clinical evaluation efforts in connection with the Company's Immuno-oncology Program, Ischemic Repair Program, Immune Modulation Program and other cell therapies, the future of the regenerative medicine industry and the role of stem cells and cellular therapy in that industry, and the performance and planned expansion of the Company's wholly-owned subsidiary and its center of excellence for cell therapy process development, engineering and manufacturing, PCT. The Company's further development is highly dependent on future medical and research developments and market acceptance, which is outside of its control. The Company's actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see the factors described under the heading, “Item 1A. Risk Factors" in the Company's Annual Report on Form 10-K filed with the SEC on March 2, 2015 and those described in the Company's other periodic filings with the SEC. The Company undertakes no obligation to update or revise any forward-looking statements.
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