CEO Blog

Nick Colangelo

President and CEO of Aastrom

Nick joined Aastrom in 2013 with more than twenty years of executive management and corporate development experience in the biopharmaceutical industry, including nearly a decade with Eli Lilly and Company. Most recently, Nick was President and Chief Executive Officer of Promedior, Inc.  During his career, he has held a variety of executive positions of increasing responsibility in product development, pharmaceutical operations, sales and marketing, and corporate development.  He has extensive experience in the acquisition, development and commercialization of therapies to treat fibrovascular, metabolic and cardiovascular diseases.  During his tenure at Eli Lilly and Company, Nick held positions as Director of Strategy and Business Development for Lilly’s Diabetes Product Group and also served as a founding Managing Director of Lilly Ventures. Nick received his B.S.B.A. in Accounting, Magna Cum Laude, from the State University of New York at Buffalo and a J.D. degree, with Honors, from the Duke University School of Law.

Insights into DCM and the ixCELL-DCM Trial

June 12th, 2013

During our first-quarter earnings call last month, I was pleased to report that we began treating patients in the ixCELL-DCM Phase 2b trial, which is evaluating ixmyelocel-T for the treatment of advanced heart failure due to ischemic dilated cardiomyopathy (ischemic DCM). This clinical trial offers a potentially historic advancement in the treatment of patients with advanced heart failure due to ischemic DCM, an indication for which we have an orphan drug designation in the United States.

DCM is a condition in which the heart becomes weakened and enlarged and cannot sufficiently pump blood throughout the body. DCM is the third most common cause of heart failure and the most frequent cause of heart transplantation. A majority of the advanced heart failure patients who no longer respond to medical therapy — more than a quarter of a million patients in the U.S. — have DCM, and approximately 60% of these cases are of ischemic origin due to prior heart attacks or atherosclerosis. These patients typically have maximized their use of prescription and device therapies, and are no longer candidates for procedures to restore blood flow such as angioplasty and bypass surgery. At this stage of the disease, they have very limited treatment options, which generally include placement of left ventricular assist devices and heart transplantation.

What makes advanced heart failure due to ischemic DCM so challenging for patients is its impact on daily life. The condition significantly reduces exercise capacity and quality of life, because for many patients, walking even a short distance causes severe shortness of breath and fatigue. There is a strong rationale for developing ixmyelocel-T for the treatment of ischemic DCM. In preclinical studies, ixmyelocel-T was found to significantly reduce cardiac tissue damage and demonstrated additional cardioprotective effects in relevant disease models. In Phase 2a clinical trials, ixmyelocel-T was found to be well-tolerated and demonstrated positive efficacy trends, including improved symptoms and improved walking distance in treated patients compared to placebo.

The ixCELL-DCM Phase 2b trial is designed to enroll 108 patients at about 30 sites in the U.S. and Canada. This is a double-blind, placebo-controlled trial that will primarily measure mortality, hospitalizations, and heart failure emergency room visits in trial participants. The trial also will examine a range of clinical, functional, and symptomatic measures. The study is on track to complete enrollment by the end of Q1 2014 and show top-line results in Q2 2015.

Aastrom is one of the few companies working to develop a treatment for this major unmet medical need, and our clinical research program for ixmyelocel-T is one of the most advanced global research efforts in regenerative medicine. As we continue to make progress, we look forward to the opportunity to share our results and insights with patients, physicians, and researchers around the world.

Regards,

Nick Colangelo

The Next Chapter for Aastrom

April 4th, 2013

Our recent decision to implement a strategic change in our R&D programs to focus on the development of ixmyelocel-T for the treatment of dilated cardiomyopathy (DCM) and stop enrollment in the Phase 3 REVIVE trial in critical limb ischemia (CLI) reflects the significant opportunity that we see to treat advanced heart failure caused by DCM and the challenges that we faced in enrolling the REVIVE study in a reasonable timeframe.  While we believe that ixmyelocel-T has strong therapeutic potential to treat CLI, based on previous clinical results showing that ixmyelocel-T was efficacious and well-tolerated in this patient population, the decision was based on our need to allocate resources to advance ixmyelocel-T toward commercialization as quickly as possible.  We believe that the DCM program represents our best near-term opportunity to accomplish this goal.

Our previous results in DCM —in both preclinical and clinical studies — suggest that our patient-specific multicellular therapy can produce a range of clinical benefits for patients with severe heart failure whose limited treatment options include heart transplantation. Read More…

The Promise of Cell Therapies in Cardiovascular Disease

February 1st, 2013

Dear Friends of Aastrom,

February is American Heart Month, and it is during this time that we recognize many of the important advances in medical research that may help us prevent and treat cardiovascular disease more effectively. In recent years, breakthroughs in surgery, drug therapy and devices have expanded options for patients, making it possible to lower the risk of a cardiac event and treat the effects of peripheral artery disease (PAD). Despite these advances, cardiovascular disease remains the leading cause of death in the United States. Each year it disrupts the quality of life of millions of people and is the cause of approximately 160,000 amputations and 1.5 million heart attacks in the U.S.

Fortunately, there are reasons to be optimistic. Recent advances in regenerative medicine and cell therapy are encouraging and have shown the potential to improve the lives of patients with the most severe forms of cardiovascular disease. In preclinical and clinical studies, cell therapies have demonstrated the potential to repair damage to the heart muscle and other vascular tissue that can occur with a cardiac event. They also have the potential to help restore blood flow or repair genetic defects. If we continue to make clinical progress in this area, cell therapies may become an effective, less costly treatment option for people with advanced cardiovascular disease. Read More…

New Year, New Opportunities at Aastrom

January 1st, 2013

Dear Friends of Aastrom,

As the new interim chief executive officer of Aastrom Biosciences, I am honored to lead the company as we continue to advance the clinical research programs for our lead product candidate, ixmyelocel-T.  I believe we have a unique opportunity to improve the lives of people with severe, chronic cardiovascular diseases with ixmyelocel-T, and am very pleased to have the opportunity to bring my experience building successful pharmaceutical brands to this development program as we begin to formulate plans related to commercialization.  Since I joined Aastrom in August as chief commercial officer, I have seen firsthand the potential of our technology to treat these diseases and the dedication of our team to bring this promising therapy to patients who may benefit from it. Read More…

A Commitment to Transparency

December 1st, 2012

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.

Read More…

Ixmyelocel-T: From Product Candidate to Product

November 1st, 2012

Dear Friends of Aastrom,

There have been many studies over the years highlighting the fact that drug discovery and development is typically a very long, risky, complex and costly process.  It is not uncommon for drug development programs to last a decade or more, beginning with early-stage discovery and research, and progressing through late-stage clinical development, regulatory review and approval.  Within that timeline, companies must continually monitor progress and determine when and whether to expand their focus to include essential commercialization strategies to prepare to bring promising late-stage product candidates to the patients who need them.

Over the past year, Aastrom has initiated a number of important activities to support the future commercialization of ixmyelocel-T, which is currently in Phase 3 clinical trials for the treatment of patients with severe peripheral arterial disease (PAD) and existing tissue loss, and in Phase 2 trials for the treatment of patients suffering with dilated cardiomyopathy (DCM). Read More…

Regulation in Regenerative Medicine: Patient Safety Has to Come First

October 1st, 2012

Dear Friends of Aastrom,

In July 2012, after several companies had been treating patients with unapproved stem cell therapies, the U.S. District Court in Washington affirmed the right of the FDA to regulate therapies made from a patient’s own stem cells. I believe this is a good decision that will protect patients, strengthen our industry and ensure the safety and therapeutic value of approved products.

The move to introduce appropriate oversight and regulation of cell therapy comes as no real surprise – the number of authorized cell therapy clinical trials has increased steadily in the U.S. over the past 10 years, from 12 trials initiated in 2001 to more than 50 trials initiated in 2011. While certain aspects of the U.S. regulatory process might be considered burdensome, I believe it is imperative that stem cell therapies be tested rigorously and to the highest standards. The fact that cell therapies are derived from cells found in the body does not eliminate this responsibility. Regenerative medicine has transformational potential, but that does not necessarily mean that each cell therapy technology or product will result in a safe and effective therapy.

Clinical trials often identify unexpected and unanticipated safety issues. Rigorous clinical trials also often find that some proposed products are not as efficacious as they need to be to balance their risks. For example, only one in four biologic treatments has ultimately proven to be both safe and effective, according to a BioMedtracker study. Marketing any therapy – for cancer, heart disease or any other disease – that has not been proven to be both safe and effective in rigorous clinical trials puts patients at risk and ultimately hurts all research organizations working to develop new therapies. Read More…

Targeting Dilated Cardiomyopathy: A Rapidly Progressing Condition with No Cure

July 5th, 2012

Dear Friends of Aastrom,

Dilated cardiomyopathy (DCM) is a progressive disease of heart muscle. It is now the third most common cause of heart failure, which affects approximately 4.9 million people in the United States (www.americanheart.org). Dilated cardiomyopathies are associated with both systolic abnormalities (difficulty of the left ventricle to empty or eject blood from its chamber) and diastolic abnormalities (increased resistance to filling of one or both ventricles). The progression of DCM can be rapid; studies have found that 50 percent of the deaths from DCM occur within two years of diagnosis (http://health.usnews.com).

Currently, there is no cure for DCM, but cardiac medications, lifestyle changes and implantable devices can help to control some symptoms.  When these treatment options can no longer control symptoms of DCM, heart transplantation may be the only option for many patients – in fact, DCM is now the most frequent cause of heart transplantation (www.americanheart.org).  Unfortunately, there are only enough donors for about 2,000 heart transplants each year.  More than 95% of patients with moderate or severe heart failure (NYHA Class III or IV) will not be able to get a transplant. (Zacks)

One sign of hope is research showing that mesenchymal cells, monocytes and alternatively activated macrophages can have a positive impact on heart muscle and function damaged by DCM. Read More…

The Critical Role of Clinical Trial Investigators

May 21st, 2012

Dear Friends of Aastrom,

Planning and executing a clinical trial requires a monumental effort with careful planning and coordination at every stage. But it always starts with a fundamental need – a team of clinical investigators and staffs who will coordinate patient screening and care, and also handle the necessary record keeping and reporting to support regulatory submissions.

In our experience at Aastrom, working with experienced and dedicated investigators provides us with essential support in the earliest stages of our planning for clinical trials. Our investigators contribute important insights and recommendations related to study design planning and methodology. We work to establish clear and open lines of communication right from the start, and maintain those open channels at every stage as the trial advances to completion.

In our clinical research thus far, we have been privileged to work with many of the leading clinicians and practices in the treatment of critical limb ischemia (CLI) and dilated cardiomyopathy (DCM). CLI is the most severe form of peripheral arterial disease (PAD) caused by chronic inflammatory processes associated with atherosclerosis that result in markedly reduced blood flow to the legs, feet and hands. There are an estimated 10-12 million people with PAD in the United States and over 1 million people with CLI. Read More…

Targeting CLI: A Major Unmet Need for Patients and a Significant Opportunity for Aastrom

April 24th, 2012

Dear Friends of Aastrom,

Over one million people in the U.S. are living with critical limb ischemia (CLI), a severe form of peripheral arterial disease (PAD).  CLI is a devastating and often fatal disease where blood flow to extremities is restricted, resulting  in debilitating pain, life-threatening infections, loss of limbs, and death. There are currently no FDA-approved therapies to treat CLI; the most frequent treatment option is revascularization surgery to restore blood flow to affected areas.  However, all too often, especially for very ill CLI patients, revascularization surgery is not effective.  At Aastrom we are applying our proprietary cell-processing technology to develop an entirely new approach to the treatment of CLI. Read More…

Stem-Cell Therapy and Patient Safety – The Source Matters

February 6th, 2012

Dear Friends of Aastrom,

The issue of safety associated with stem cell therapies has been in the news recently. Last month, the FDA issued a consumer update describing potential risks associated with the use of stem cell therapies that have not yet been approved. Also recently, 60 Minutes ran a story about patients with severe illnesses who sought treatment with unapproved stem-cell therapies when no approved treatment options were available. In many cases, these patients paid vast sums of money and traveled to other countries to be treated with potentially dangerous and unregulated cell therapies.

These reports highlight the value of appropriate safety standards in the development of cellular therapies, standards which Aastrom maintains in all of its development, manufacturing and shipping procedures. These stories also raise an important issue about the different types of stem cells used in medical research and drug development, and the need to define clearly which cell types are being used. In many cases, the ethical or safety concerns associated with cell therapies relate to the use of embryonic stem cells, not the use of adult or autologous (“patient-specific”) stem cells which we use at Aastrom. Therapies derived from non-embryonic stem cell therapies are now approved for use in treating more than 70 medical conditions. 1, 2

In the development of our cellular-medicine product, Aastrom uses the patient’s own bone marrow, which is collected in an outpatient setting. After the sample arrives at our laboratory in Ann Arbor, each step of the production process is carefully monitored to meet or exceed the safety and quality standards established by the FDA. Read More…

Aastrom Nearing Launch of Phase 3 Revive Clinical Trial for Critical Limb Ischemia

December 9th, 2011

Dear Friends of Aastrom,

As you may have noticed, we recently redesigned the Aastrom website to help visitors access more information about our company. We hope this redesign makes it easier to learn about our work, mission and progress. To support the new site, we are also introducing a new blog about Aastrom where we will offer perspectives on important issues associated with our work and industry. I am very pleased to begin this new series with some comments on the disease that has been a primary focus of our work and research at Aastrom for the past several years—critical limb ischemia (CLI). (Learn more about critical limb ischemia or Aastrom’s CLI clinical trials, or watch the Living with CLI video.)

The importance of our CLI program cannot be overstated, as the need for a new treatment to help the millions of people affected by this terrible disease has never been greater. Read More…