NeoStem's PCT unit named manufacturer in Baxter phase III stem cell trial
Unique cell therapy company NeoStem's (AMEX:NBS) Progenitor Cell Therapy (PCT) unit Tuesday was named as the contract manufacturer for a Baxter International (NYSE:BAX) Phase III stem cell trial.
Baxter Tuesday started a phase III pivotal clinical trial to evaluate the efficacy and safety of an individual's own CD34+ stem cells to increase exercise capacity in patients with chronic myocardial ischemia (CMI), a coronary artery disease.
CMI is one of the most severe forms of coronary artery disease, causing significant long-term damage to the heart muscle and disability to the patient. It is often diagnosed based on symptoms of severe, refractory angina, which is severe chest discomfort that does not respond to conventional medical management or surgical interventions.
Speaking to Proactive Investors, NeoStem chief executive Robin Smith said: "It's really exciting. As our clients progress in phases, revenue goes up dramatically."
In terms of the trial's financial impact, Smith said: "With the addition of Progenitor Cell Therapy (PCT) in January of 2011, our revenues have diversified with over 10 percent attributable to PCT.
"As the cell therapy industry progresses and our clients accelerate through the clinical trial pathways these revenues will rapidly grow."
Cell therapy is typically more expensive, requiring thousands of dollars to manufacture an individual cell therapy. Baxter has announced 450 patients for its trial.
It may take the pharmaceutical giant a few years to enroll all of these patients. The primary endpoint measured at the 12 month follow up is a patient's total exercise capacity.
Smith added: "We are very excited to see the results of the phase III data when published as the phase II trial provided evidence that leveraging the body's own natural repair mechanisms can improve exercise capacity and reduce chest pain."
Baxter is taking a slightly different approach in its CMI therapy, opting to inject cells directly into the heart.
"NeoStem's AMR-01 therapy is different in that the cells they use are not injected into the heart muscle. These cells are infused into the infarct-related artery and mobilize to the area of injury where they are needed," Smith said.
NeoStem has both methods and composition of matter patents and recently announced the expansion of their patent portfolio.
Amorcyte has issued U.S. patents that broadly cover the use of stem cells for the treatment of vascular injury caused by vascular insufficiency. The company believes these patents cover any commercially viable use of stem cells for the repair of vascular injury resulting from any ischemic event, including, for example, acute myocardial infarction (AMI).
Amorcyte's U.S. Patent No. 7,794,705 covers a cell-based therapy to repair damage from a heart attack resulting from underlying diseases in patients who have undergone a surgical procedure to restore blood supply to the heart accomplished by using a composition that contains a therapeutically effective amount of a chemotactic hematopoietic stem cell product; the product includes a cellular component containing a population of autologous mononuclear cells from any source enriched for CD34 cells, where the CD34 cells contain a subpopulation of biologically active CD34+/CXCR-4+ cells that, when delivered by catheter whenever needed, can migrate in a directed fashion to areas of ischemic damage and effect repair, and a serum component that maintains the biological activity of these motile cells and enables commercial processing of the cells.
U.S. Patent 8,088,370 covers a cell-based therapy to repair damage from any vascular injury caused by vascular insufficiency accomplished by using a composition that contains a therapeutically effective amount of a chemotactic hematopoietic stem cell product; the product includes a cellular component containing a population of autologous mononuclear cells from any source enriched for CD34 cells, where the CD34 cells contain a subpopulation of biologically active CD34+/CXCR-4+ cells that, when delivered by catheter whenever needed, can migrate in a directed fashion to areas of ischemic damage and effect repair, and a serum component that maintains the biological activity of these motile cells and enables commercial processing of the cells.
Stem cell processing for Baxter's trial will be conducted in Good Manufacturing Practice (GMP) facilities in the US by PCT.
With over 12 years of experience, PCT is an industry leader in contract development and manufacturing of cell therapy products.
PCT is the only contract development and manufacturing organization to see its client's cell therapy product receive marketing approval from the FDA.
NeoStem is an international biopharmaceutical company with adult stem cell operations in the US, a network of adult stem cell therapeutic providers in China as well as a 51 percent ownership interest in a profitable Chinese generic pharmaceutical manufacturing company.
The company is focused on accelerating the development of proprietary cellular therapies and becoming a single source for
collection, storage, manufacturing, therapeutic development and transportation of cells for cell-based medicine and regenerative science globally.