Dear Friends of Aastrom,

Aastrom’s commitment to transparency was reinforced by the recent announcement from GlaxoSmithKline (GSK).  GSK made headlines when it announced a new policy to disclose all clinical data from the company’s drug development programs.  Previously, the company had followed prevailing industry standards by releasing results from only some of its clinical studies (generally, only the positive ones).  A 2008 study[i] by the University of California, San Francisco found that many drug companies do not routinely report negative clinical data, while some do not make any data available to the public.  We welcome GSK’s initiative – it is good clinical practice and consistent with our commitment to transparency at Aastrom.  This move toward greater transparency is an important trend with profound implications for the future of research.

We believe that the benefits of disclosing all clinical results, not just the positive study results, far outweigh the real or perceived risks.  Full disclosure allows any interested party to review all of the potentially relevant data about experimental therapies.  This allows for a much broader and more accurate assessment of both safety and efficacy – the mechanisms of action – and also enables scientists and physicians to identify potential areas for future research.  When publicly available information is incomplete, it can lead the medical community to flawed conclusions that may limit the chances of future clinical success or, in extreme cases, actually cause patients harm.

Many researchers share our view that more transparency from our industry (pharmaceutical and biotechnology companies), including the creation of a global clinical research database, will help address these issues.  Peer review is a critical element of this transparency.  We encourage our study investigators to publish data from our clinical programs in peer-reviewed journals or present their findings at international peer-reviewed medical meetings.   This includes data from clinical studies, studies related to our manufacturing processes and early preclinical research.  We have also maintained a commitment to sharing the results of all of our clinical research programs, and will continue to do so.

For example, earlier this year Aastrom presented two posters with data showing new potential therapeutic advantages of ixmyelocel-T, our investigational regenerative medicine therapy that is currently in Phase 3 clinical trials for the treatment of critical limb ischemia and in Phase 2 trials for the treatment of dilated cardiomyopathy.   At the Keystone Symposia on the Molecular Basis of Vascular Inflammation and Atherosclerosis held in Big Sky, Montana in March, we presented data showing that ixmyelocel-T may have atheroprotective properties.  In a separate in vitro study, ixmyelocel-T was shown to resolve atherosclerotic lesions, or plaques, that form inside the arteries.  These findings are potentially exciting but need to be shared publicly to help medical experts assess these findings and confirm their validity.

In June 2012, Aastrom also announced the results of a second preclinical study to evaluate the ability of ixmyelocel-T to protect the heart from damage in a murine (mouse) model of heart failure.  In this model of non-acute left anterior descending (LAD) coronary artery occlusion, animals treated with ixmyelocel-T demonstrated reduced mortality compared to the control group (22% vs 44%).  Again, our disclosure of these results was consistent with good disclosure practice and reflected our commitment to maintaining the integrity of our development programs.

For those of you interested in taking a closer look, links to all of the available data from our critical limb ischemia and dilated cardiomyopathy development programs may be found on our scientific publications page. This page includes access to journal articles, presentations and posters.

We look forward to continuing the development of ixmyelocel-T and providing full disclosure of our clinical results.  Transparency is a core value for Aastrom – it will help ensure that we continue earn the trust of patients and medical professionals who may rely on our therapies, gain the support of investors who help finance our business and help researchers in regenerative medicine identify promising new avenues of research in regenerative medicine.

With regards,

Tim


[i] Rising K, Bacchetti P, Bero L. Reporting bias in drug trials submitted to the Food and Drug Administration: review of publication and presentation. PLoS Med. 2009 Jan;6(1)