On January 19, 2011, NeoStem acquired Progenitor Cell Therapy, a cell therapy contract manufacturing company serving the industry from licensed, state-of-the art facilities in New Jersey and California. This event added to NeoStem over 100 years of collective experience in the business and science of cell therapy and its development. PCT has performed over 30,000 cell therapy procedures and processed and stored over 18,000 cell therapy products and arranged the logistics and transportation for over 14,000 cell therapy products for clinical use by over 5,000 patients.
The PCT acquisition puts NeoStem in an excellent position as it transitions to cell-based therapeutics. A primary initial therapeutic agent is AMR-001, the lead product candidate of newly acquired Amorcyte. AMR-001 is an autologous stem cell treatment designed to prevent adverse cardiac events following acute myocardial infarction. A Phase II trial for Amorcyte is expected to enroll the first patient early in 2012.
Through the PCT acquisition, NeoStem also owns 80% of Athelos Corporation, a company developing a T-cell therapeutic with potential in a range of auto-immune conditions such as graft versus host disease, asthma and diabetes.
NeoStem has had a foothold in China since 2009, when the company acquired a controlling interest in Suzhou Erye Pharmaceuticals Ltd., or Erye. Erye has recently built and validated a new manufacturing facility, doubling its capacity and creating capacity within its existing production lines for higher margin products. With the objective of fully focusing its efforts and resources on cell therapeutics, NeoStem is currently pursuing the divestiture of Erye, where sales have grown from $32 million in 2007 to $69 million in 2010.
In 2009, NeoStem also began several China-based, adult stem cell initiatives including: (i) creating a separate China-based stem cell operation, (ii) constructing a stem cell research and development laboratory and processing facility in Beijing, planned by Progenitor Cell Therapy to the same standards as the PCT sister facilities in Mountain View, California, and Allendale, New Jersey (iii) establishing relationships with hospitals to provide stem cell-based therapies, and (iv) obtaining product licenses covering several adult stem cell therapeutics focused on regenerative medicine. To date, NeoStem has established relationships with three hospitals in China to offer its licensed adult stem cell technology for orthopaedic indications using mesenchymal stem cells, and this hospital network continues to grow. NeoStem’s Beijing facility is poised to begin work for PCT’s clients so that they can be offered manufacturing on two continents.
In 2007, NeoStem began its development activities for diagnostic and therapeutic applications of autologous adult stem cells with the acquisition of a worldwide exclusive license to VSELTM Technology, very small embryonic-like stem cells, licensed from the University of Louisville. Since that time, NeoStem has entered into partnerships, sponsored research agreements, or grant-funded studies for VSELTM Technology highlighting the potential range for these regenerative cells, including studies targeting osteoporosis and bone health improvement (received over $1.7 million in Department of Defense funding), bone regeneration (over $100,000 in NIH funding), macular degeneration and glaucoma, liver regeneration, chronic wound healing, and motor neurons.
- Began patient enrollment for Amorcyte PreSERVE Phase 2 trial for acute myocardial infarction
- Expanded Amorcyte intellectual property protection coverage beyond current target indication for AMR-001
- Held first International Vatican Conference on Adult Stem Cell Research, in partnership with the Vatican’s Pontifical Council for Culture in November
- Acquired Amorcyte, Inc, with a Phase II ready asset for acute myocardial infarctions and a Phase I ready asset for congestive heart failure
- Acquired Progenitor Cell Therapy, whose services include cell therapy, contract manufacturing, and cord blood banking, as well as an 80% ownership of Athelos Corporation, company developing T-cell therapeutic with potential for a range of auto-immune conditions
- Awarded and received over $1.7 million from Department of Defense Peer Reviewed Medical research Program to employ VSEL™ technology to treat osteoporosis and improve bone health
- Launched Family Stem Cell Bank business, combining cGMP-standard cord blood banking and adult stem cell banking
- Raised over $16.5 million in capital
2010
- Awarded contract with U.S. Army Medical Research and Materiel Command, Telemedicine and Advanced Technology Research Center to evaluate the use of adult stem cells for rapid wound healing
- NeoStem named “Best Stem Cell Company” in The New Economy’s 2010 Biotech Awards
- Announced breakthrough partnership between the Vatican’s Pontifical Council for Culture and the Stem For Life Foundation
- Launch of R&D Laboratory in Cambridge, Massachusetts
- Co-inventor of VSEL™ Technology, Dr. Mariusz Ratajczak, joins Scientific Advisory Board
- Raised over $30 million in capital
- PCT announced the first stage of its Allendale facility build was complete *
- Commenced operations in China
- In-licensed stem cell applications for cosmetic, orthopedic, wound healing
- Partnered with Enhance Biomedical – treatment network in PRC and Taiwan for stem cell therapeutics
- Acquired 51% stake in Chinese pharmaceutical company Suzhou Erye
- Awarded National Institutes of Health Grant to study stem cell therapy for bone defects
- Raised $16 million
- PCT began build-out of its Allendale facility *
- The CIRM (California Regenerative Medicine Institute) awarded a number of grants to 14 different Disease Teams (averaging $16 million each) - PCT is a member of a number of those teams*
- Amorcyte presents Phase I study results at American College of Cardiology Annual Scientific Session *)
- Received federal funding from the Department of Defense to evaluate the potential of adult stem cell therapy for wound healing
- Raised $1.75 million
- PCT acquired a new facility in Allendale, NJ *
- Amorcyte completes Phase I trial of stem cell therapy for acute myocardial infarction *
- Acquired world-wide exclusive license to VSEL™ Technology from University of Louisville
- Received listing on American Stock Exchange
- Raised $8.5 million
- Appointed Dr. Robin L. Smith as CEO
- Raised $3.75 million
- PCT spun off Amorcyte, Inc. to independent investors providing first-round financing*Amorcyte begins Phase I trial at Emory University *
- PCT expanded its manufacturing space in the Mountain View facility*
2005
- PCT launched DomaniCell as a wholly-owned subsidiary*
- PCT extended manufacturing contracts with Dendreon for phase III product manufacturing for Dendreon's PROVENGE*
- PCT incorporated Amorcyte, Inc.*
- PCT expanded its East Coast processing capacity and established Amorcyte, Inc.*
- PCT established its second facility by acquiring space in Mountain View, California*
- PCT and Dendreon Corp. signed its first in a series of contracts for PCT to manufacture PROVENGE and other cell therapy cancer vaccines for phase I, II and III clinical trials*
- PCT acquired the hematopoietic progenitor cell and tissue processing laboratory from Hackensack University Medical Center (HUMC), located in Hackensack, New Jersey*
- PCT founded by Andrew L. Pecora, M.D. and Robert A. Preti, Ph.D*
* Prior to NeoStem acquisition