SALT LAKE CITY & PLANTATION, Fla.--(BUSINESS WIRE)--Q Therapeutics, Inc. (Q) and Goodwin Biotechnology, Inc. (GBI) announced today that GBI has begun process development and will be manufacturing a monoclonal antibody used by Q in purifying its cell therapy product, Q-Cells™. This IgM antibody recognizes a unique cell surface marker that is expressed on Q-Cells (neural glial cells). On successful completion of the production, Q Therapeutics will utilize the IgM antibody to manufacture the Q-Cells in accordance with FDA requirements at a cGMP production facility. Q Therapeutics anticipates beginning Phase I trials for the treatment of transverse myelitis, a rapidly paralyzing subset of multiple sclerosis (MS), in 2009.
Q’s first product, Q-Cells, is a cell-based therapeutic intended to replace the insulating myelin and provide natural supporting factors to damaged neurons, thereby restoring or preserving normal function of those neurons. Q-Cells are applicable to a wide range of demyelinating diseases, including multiple sclerosis (MS), transverse myelitis, cerebral palsy, spinal cord injury and white matter stroke. They may also have application in other neurodegenerative diseases such as ALS (Lou Gehrig’s Disease) and Parkinson’s Disease in addition to serving as unique drug screening tools to identify other pharmaceutical products.
An Important Step
“Selecting the right partner to manufacture this antibody was a critical decision we faced in preparing for our human clinical trials,” said Deborah A. Eppstein, PhD, President & CEO of Q Therapeutics. “In making this decision, we spoke with potential manufacturing partners in North America, Europe and Asia. We gave careful consideration to their experience in manufacturing these types of antibodies as well as flexibility and commitment in working with an emerging company. GBI rose to the top of the list on all counts. They have already proven themselves to be a terrific partner in meeting our technical, scheduling and business needs.”
“Our mission as a contract manufacturer is to seamlessly integrate our operation with our clients’, becoming their manufacturing divisions,” commented Stephanie Finnegan, CEO of GBI. “In this way, our team can take maximum ownership and responsibility for the success of our clients’ important projects. Our core competence is in cGMP manufacturing and manufacturing process development, not in product innovation. Thus, we are proud to take such a key role in assisting our clients to bring these life-saving therapies into and through clinical trials. We are especially honored to have been chosen by Q to assist them in development of this unique cell based therapy product, a therapeutic arena with tremendous potential.”
About Q Therapeutics Inc.
Q Therapeutics, Inc. is an emerging biopharmaceutical company, venture-backed and privately held, located in Salt Lake City, Utah. The Company has exclusive rights to 16 issued patents arising out of work done by Mahendra Rao, M.D., Ph.D., at the University of Utah and NIH. Q Therapeutics announced on February 15th that it had closed on an $8 million first tranche of its Series B financing from vSpring Capital, Invitrogen Corporation, Epic Ventures, Toucan Capital, University of Utah Research Foundation, Salt Lake Life Science Angels and Q management. Q Therapeutics’ first therapeutic product, Q-Cells, is intended to produce a replacement myelin sheath around the damaged neuronal axons of patients suffering from demyelinating diseases such as transverse myelitis and multiple sclerosis. Q-Cells may prove efficacious in other neurodegenerative diseases such as ALS (Lou Gehrig’s Disease) and Parkinson’s Disease. Clinical trials are anticipated to commence in 2009 in Transverse Myelitis, a rapidly paralyzing, inflammatory demyelinating spinal cord injury related to MS. Q’s pipeline includes other cell products for treating diseases including Alzheimer’s Disease and peripheral neuropathies. For more information, visit www.qthera.com.
About Goodwin Biotechnology Inc.
GBI is one of the earliest contract manufacturing organizations (CMOs), established in 1992. GBI specializes in process development and cGMP compliant mammalian cell culture manufacturing of bio-therapeutics for pre-clinical studies through Phase III clinical trials. The company and its predecessor, The Goodwin Institute for Cancer Research have been operating in the biologics CMO sector since the early 1980’s. GBI's clients include small to midsized biotech companies throughout North America and Europe, universities, renowned cancer research institutes and various branches of the U.S. government. GBI was acquired in 2004 by Wallace Pharmaceuticals Pvt. Ltd., a multi-specialty pharmaceutical manufacturer and distributor based in Goa, India. GBI and Wallace together offer clients the experience of an established US Contract Manufacturing Organization together with the potential for timeline and cost-effective scale up manufacturing in India. For more information, visit www.goodwinbio.com.
This press release may contain, in addition to historical information, certain forward-looking statements that involve risks and uncertainties. Such statements reflect management’s current views and are based on certain assumptions. Actual results could differ materially from those currently anticipated as a result of a number of factors, including risks and uncertainties.