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NeoStem Announces New VP Of Clinical Development, Regulatory Affairs

NeoStem (AMEX:NBS) announced Wednesday that Jonathan Sackner-Bernstein, MD, FACC has joined the firm as VP of clinical development and regulatory affairs.

Sackner-Bernstein has over 20 years of experience as a clinical cardiologist and medical researcher, with leadership in healthcare management.

The company said Sackner-Bernstein will join the team to advance Amorcyte's PreSERVE AMI phase 2 trial, in addition to providing regulatory support for NeoStem's product pipeline.

Amorcyte, acquired by NeoStem in October 2011, is developing a cell therapy for the treatment of cardiovascular disease.

Amorcyte's lead compound, AMR-001, represents NeoStem's most clinically advanced therapeutic, with the company having started enrollment for a phase 2 trial to investigate AMR-001's efficacy in preserving heart function after a heart attack.

"Jonathan's experience at the FDA and with Clinilabs, coupled with his experience as a cardiologist, make him a perfect choice to develop Amorcyte's AMR-001, in part by leveraging his relationships with clinical investigators and leaders in the cardiology community," said NeoStem's chief medical officer, Dr. Andrew Pecora.

NeoStem also acquired Progenitor Cell Therapy (PCT) in January 2011, and the company said that provided it a foundation in both manufacturing and regulatory affairs expertise.

Athelos Corp, which is approximately 80 percent-owned by NeoStem's subsidiary, PCT, is engaged in collaboration with Becton-Dickinson (NYSE:BDX) that is exploring the earlier stage clinical development of a T-cell therapy for autoimmune conditions.

NeoStem chairman and CEO Dr. Robin L. Smith said: "NeoStem has successfully repositioned the company through the acquisitions of both PCT and Amorcyte, effectively transforming our company to one that is focused on the development of novel cell based therapeutics and, as such, management is focused on execution to build investor confidence and bring value to our shareholders."

Earlier this month, NeoStem said closed the previously announced underwritten public offering, raising gross proceeds of $6.8 million.

The new funds will be used for working capital purposes, including research and development of cell therapeutic product candidates, expansion of business units, strategic transactions and other general corporate purposes.

NeoStem has continued to devote its resources to its cell therapy business, including manufacturing, therapeutic development, and related activities. Its revenues are derived from a combination of areas, including the contract manufacturing services performed by the PCT, whose manufacturing base is one of the few accredited facilities available for contracting in the cell therapy industry.

For 2011, the company reported revenues of $73.7 million, compared to $69.8 million in 2010.

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.

NeoStem's shares were up 4.52 percent on Wednesday afternoon, at 32 cents.