Posted on April 24th, 2014
by Douglas Losordo
To briefly introduce myself, I am an interventional cardiologist by training and serve as the Chief Medical Officer of NeoStem. Previously I served as Vice President, New Therapies Development, Regenerative Medicine and Baxter Ventures at Baxter International. I also served as director of the Feinberg Cardiovascular Research Institute at Northwestern University’s School of Medicine as well as director of the Program in Cardiovascular Regenerative Medicine at Northwestern Memorial Hospital and prior to that as the Director of Cardiovascular Research at St. Elizabeth’s Medical Center in Boston. My major research interests cover angiogenesis/vasculogenesis (growing new blood vessels), progenitor/adult stem cells, tissue repair/regeneration, and vascular biology.
My interest in progenitor and adult stem cells can be traced to a well-known paper. It’s been 17 years since Dr. Takayuki Asahara and Dr. Jeffrey M. Isner published their landmark paper in Science, identifying the endothelial progenitor cell, or the EPC as we now know it, as an adult cell with the capability of building new or repairing damaged blood vessels. At the time the concept was foreign and clearly challenged the orthodoxy of the stem cell cogniscenti, and Asahara and Isner were subject to the type of ad hominem attacks that one normally associates with politics, not science. Now, 17 years later, there is general acknowledgment of the fact that every organ has the capability of self-repair via stem and progenitor cells residing throughout the body.
As a result, there is great interest in exploiting this natural repair capability for therapeutic purposes. There is still much knowledge to be gained and work to be done, and I’m sure that when we look back in another 17 years we will realize again how far we have come. Back in 1997 when Asahara and Isner were being attacked they simply let the data speak, performing experiment after experiment until the weight of evidence was simply overwhelming. That’s always been my philosophy, let the evidence do the talking.
If you are a casual observer, patient, family of a patient or even an investor, synthesizing the dizzying array of information about stem cells can be difficult as the quality of data provided is variable, sometimes conflicting, and, unfortunately, sometimes inaccurate. Even worse, this can also make it difficult for interested parties to understand the available possibilities for themselves or a loved one.
In an effort to continue to educate and inform, and yes, sometimes to opine, I’ve decided to start a blog. I look forward to commenting on news stories, recent publications and other information that I come across and welcome feedback.
Douglas W. Losordo, M.D.
Chief Medical Officer
Forward Looking Statements
This blog contains “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995, as well as historical information. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements, or industry results, to be materially different from anticipated results, performance or achievements expressed or implied by such forward-looking statements. When used in this blog, statements that are not statements of current or historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, the words “plan,” “intend,” “may,” “will,” “expect,” “believe,” “could,” “anticipate,” “estimate,” or “continue” or similar expressions or other variations or comparable terminology are intended to identify such forward-looking statements, although some forward-looking statements are expressed differently. We remind readers that forward-looking statements are merely predictions and therefore inherently subject to uncertainties and other factors and involve known and unknown risks that could cause the actual results, performance, levels of activity or our achievements or industry results, to be materially different from any future results, performance levels of activity or our achievements or industry results expressed or implied by such forward-looking statements. Such forward looking statements appear in this blog. Factors that could cause our actual results to differ materially from anticipated results expressed or implied by forward-looking statements include, among others:
• our ability to obtain sufficient capital or strategic business arrangements to fund our operations and expansion plans, including meeting our financial obligations under various licensing and other strategic arrangements, the funding of our clinical trials for product candidates in our development programs for our Targeted Cancer Immunotherapy Program, our Ischemic Repair Program and our Immune Modulation Program, and the commercialization of the relevant technology;
• our ability to build and maintain the management and human resources infrastructure necessary to support the growth of our business;
• our ability to integrate our acquired businesses successfully and grow such acquired businesses as anticipated, including expanding our PCT business internationally;
• whether a large global market is established for our cellular-based products and services and our ability to capture a meaningful share of this market;
• scientific and medical developments beyond our control;
• our ability to obtain and maintain, as applicable, appropriate governmental licenses, accreditations or certifications or comply with healthcare laws and regulations or any other adverse effect or limitations caused by government regulation of our business;
• whether any of our current or future patent applications result in issued patents, the scope of those
patents and our ability to obtain and maintain other rights to technology required or desirable for the conduct of our business; our ability to commercialize products without infringing the claims of third party patents;
• whether any potential strategic or financial benefits of various licensing agreements will be realized;
• the results of our development activities, especially:
• the results of our planned Intus Phase 3 clinical trial of NBS20 being developed to treat metastatic melanoma;
• the results of our PreSERVE Phase 2 clinical trial of NBS10 being developed to treat acute myocardial infarction for which we released initial data on November 17, 2014 and for which all 6 and 12 month data has been collected; however it is subject to ongoing analysis, and currently reported results, although promising, are preliminary and there can be no assurance that further analysis may not reveal negative, or less promising, results;
• our ability to complete our other planned clinical trials (or initiate other trials) in accordance with our estimated timelines due to delays associated with enrolling patients due to the novelty of the treatment, the size of the patient population and the need of patients to meet the inclusion criteria of the trial or otherwise; and
• the other factors discussed in “Risk Factors” in our Form 10-K filed with the Securities and Exchange Commission (“the SEC”) on March 2, 2015, and elsewhere in the Annual Report on Form 10-K.
The factors discussed herein, including those risks described in Item 1A. “Risk Factors” in the Company's Annual Report on Form 10-K filed with the SEC on March 2, 2015 and in the Company's other periodic filings with the Securities and Exchange Commission (the “SEC”) which are available for review at www.sec.gov under “Search for Company Filings” could cause actual results and developments to be materially different from those expressed or implied by such statements. All forward-looking statements attributable to us are expressly qualified in their entirety by these and other factors. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the Company undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.