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.

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…

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…

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…

Unlocking the Potential of Regenerative Medicine

January 17th, 2012

Dear Friends of Aastrom,

Regenerative medicine is the term most often used to describe research and drug development involving the use of stem cells to stimulate the body to rebuild and repair damaged tissue.  Based on the results of multiple research programs in the U.S. and other countries, regenerative medicine has the potential to cure or reverse the symptoms of many diseases that affect different tissues in the body, including vascular, muscle, organ, bone and nerve tissues.

Today, the field of regenerative medicine encompasses many approaches to treatment, including:

  • therapies administered by injection to promote tissue healing and organ regrowth;
  • the growth of new tissue and organs in a laboratory for implantation in patients; and
  • the use of biocompatible materials or small molecules to support the body’s natural ability to regenerate tissue.

At Aastrom, our approach to regenerative medicine is to use a patient’s own cells to develop a therapy that includes the optimal range and ratio of cells to treat severe, chronic ischemic cardiovascular diseases such as critical limb ischemia (CLI) and dilated cardiomyopathy.  The product we are developing, ixmyelocel-T, is personalized and custom-made for each patient from a small amount of his or her own bone marrow cells.  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…