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BSYI (OTCBB) BioSyntech, Inc. - Cerebragel: A Potentially Breakthrough Product for Treatment of Brain Cancer

WEDNESDAY, DECEMBER 04, 2002 07:30 AM

LAVAL, Quebec, Dec 4, 2002 (BUSINESS WIRE) -- The Therapeutics Delivery division at Biosyntech (OTCBB:BSYI) today announced the results of its pilot pre-clinical efficacy studies using Cerebragel (a unique formulation based on Biosyntech's platform BST-Gel technology) on rat glioblastoma tumor model (C-6) implanted orthotopically (in the normal position) and stereotactically (spatially controlled implantation in the brain using a stereotaxic apparatus) into Wistar rats intracranially. This work was conducted at Montreal General Hospital, McGill University.

Brain cancers are the third leading cause of death in men and the fifth in women in North America. These tumours can form at any age. Gliomas, tumors that arise from the glial (supportive) tissue of the brain, are the most common form of primary brain tumors. Conventional treatments for gliomas include combinations of surgery, radiation and chemotherapy. Gliomas infiltrate the brain surrounding the tumor. Therefore, even the most successful surgery leaves tumor cells deep inside the brain adjacent to the area that had contained solid tumor. In patients with high-grade (more malignant) gliomas, post surgical treatment often includes different combinations of radiotherapy and chemotherapy.

Systemic chemotherapy of brain tumors is limited by the blood-brain barrier impenetrability for many agents at therapeutic concentrations. As a result, effective concentrations are difficult to achieve in the brain without causing systemic adverse effects. The course of action, therefore, is to search for ways of applying the chemotherapeutic agent locally.

In the pilot project conducted at Montreal General Hospital, McGill University, C-6 glioma was used. C-6 glioma is a clonal cell line developed from a rat glioblastoma chemically induced in the brain of a Wistar rat. Transplantation of C-6 cells by stereotactic procedures produced intra-cerebral tumors presenting some of the characteristic features of spontaneous gliomas with good reproducibility. The tumors were initiated by stereotactic injection of C-6 cells into the mid striatum of anaesthetized adult rats. 12-14 days after tumor implant, Cerebragel was injected by a stereotactic procedure through the same burr hole that was used for implantation of the tumor.

Since the brain tumor was not accessible for measurement of tumor size, progress was assessed on the basis of behavioral, neurological signs and survival time of the animals. Animals were sacrificed when simultaneous expression of several of these signs indicated that the tumor had grown beyond a certain size.

In the pilot study, the animals were randomized into two groups: untreated and treated with Cerebragel. Tumor growth was monitored over a period of time. All the control untreated animals died within 25 days. However, the animals treated with Cerebragel survived beyond 5 months, and are still surviving, with no signs of any systemic toxicity or neurotoxicity. No loss in body weight and no signs of any neurological disorder were observed in animals treated with Cerebragel for a period exceeding 5 months.

Dr. Ajay Gupta, Executive Vice-President, Therapeutics Delivery at Biosyntech Inc. commented: "The initial in-vivo results for the treatment of glioblastomas using our Cerebragel product are very exciting and indicate that not only our product is potentially safe, but also has been shown to be potentially effective in inhibiting the growth of glioblastomas. Our Cerebragel product is the first ever injectable implant that can infiltrate the solid brain tumors and inhibit their growth effectively. Large scale pre-clinical trials are currently underway at Montreal General Hospital, McGill University to evaluate the potential of our revolutionary Cerebragel product for the treatment of glioblastomas".



About BioSyntech


BioSyntech Inc. is an ISO 9001:2000 certified, advanced biomaterials company specializing in tissue repair and in the delivery of therapeutic products. BioSyntech is composed of two operating divisions: tissue repair and therapeutic delivery. The Company's patented platform technology BST-Gel(TM), is a multifunctional injectable thermo-sensitive and self-forming hydrogel that can be used for tissue repair or for targeted delivery of therapeutic agents. These biomaterials are biocompatible, biodegradable, muco adhesive and provide significant advantages in specialized medical fields including, Oncology, Orthopedics, Rheumatology, Reconstructive Surgery, Tissue Engineering, Vaccines and many other therapeutic areas. For additional information, visit www.biosyntech.com.

This press release contains certain "forward-looking" statements, as defined in the United States Private Securities Litigation Reform Act of 1995 that involve a number of risks and uncertainties. There can be no assurance that such statements will prove to be accurate and the actual results and future events could differ materially from management's current expectations. Potential risks and uncertainties include timeframes and expectations for completing clinical trial research, receiving positive results from the various clinical trials, submitting results to various regulatory authorities, receiving approval for products and successfully marketing products to potential customers. These risks and factors are detailed from time to time in the company's SEC filings.


CONTACT: BioSyntech, Inc.
Alain Geahchan, 450/686-2437 ext. 312
Cell: 514/232-2213
[e-mail]

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