Data Published In PNAS Demonstrate Product Potential
Cambridge, Massachusetts, August 26, 1998
Cambridge NeuroScience, Inc. announced important advances in its Glial Growth Factor 2 (GGF2) program for Multiple Sclerosis (MS) published in the August 18, 1998 issue of Proceedings of the National Academy of Sciences.
The study, conducted by CNS in conjunction with Drs. Cedric Raine and Barbara Cannella at Albert Einstein College of Medicine in New York.
It demonstrates that treatment in an animal model of MS with recombinant human GGF2 leads to delayed onset and decreased disease severity, as well as a statistically significant reduction in relapse rate.
The study supports Cambridge NeuroScience's position as a leader in NeuroScience research and is a significant milestone in the advancement of GGF2 to clinical trials.
"Because, relapse rate has traditionally been a primary endpoint in most clinical trials of MS.
This study indicates that GGF2 may represent a useful MS therapy, either alone or in combination with existing agents," stated Harry W. Wilcox, President and CEO of Cambridge NeuroScience.
"The positive pre-clinical data support our expectation of filing an IND for GGF2 before the end of 1999."
In contrast to GGF2, MS treatments currently on the market affect only the Inflammatory or Immune Response and do not contribute to the ReMyelination of Nerves.
The study tested the effect of GGF2 on various stages of the MS model, by varying the time and dosage parameters in eleven separate experiments.
The tests were conducted on an established model of MS, where Experimental AutoImmune EncephaloMyelitis (EAE) mimics the DeMyelinating effects of MS in mice.
The study found that recombinant human GGF2 was capable of effecting recovery and repair to damaged Myelin in both Acute and Relapsing phases of the MS model.
The reduction in relapse rate is significant because this effect is correlated with the ReMyelination of Nerves.
"Because of its ability to promote the growth of new Myelin, GGF2 has the potential to prevent, halt and even reverse the progression of MS," said Dr. David Gwynne, Vice President of Biotechnology and Business Development at Cambridge NeuroScience.
Growth Factors are natural signaling molecules that play key roles in the normal development, maintenance and biological repair of all tissues and organs, including the Brain, Spinal Cord and Peripheral Nervous System.
GGF2, CNS's lead Growth Factor, is known to stimulate the growth and differentiation of Oligodendrocytes.
These Glial Cells give rise to the Myelin sheath that is responsible for insulating Nerve Cells ensuring their survival and proper functioning.
In 1996, Cambridge NeuroScience was granted a patent from the U.S. Patent and Trademark Office for composition of matter claims directed to DNA sequences encoding GGF2, and recent patent allowances broaden the coverage.
Cambridge NeuroScience is engaged in the discovery and development of proprietary pharmaceuticals focusing on Nerve Cell Survival.
The Company is developing a number of products to treat Stroke, traumatic Brain injury and Chronic NeuroDegenerative Disorders such as Multiple Sclerosis, Peripheral Neuropathies and other Degenerative Diseases.
This press release may contain forward-looking statements based on the current expectations of management.
There are certain important factors that could cause results to differ from those anticipated by the statements made above.
Including, but not limited to, the Company's ability to acquire a corporate partner to fund the development program for GGF2.
The results of the ongoing pre-clinical studies of GGF2 and the acceptance by regulatory authorities of the Company's pre-clinical data as a basis for IND approval.
Harry W. Wilcox - President and CEO
Theresa McNeely - Director