STOCKHOLM, Sweden, Dec. 15, 2005 (PRIMEZONE) -- Diamyd Medical AB (OMX:DIAMB) today announced the successful results of a pre-clinical study demonstrating the safety and tolerability of a novel formulation of the GAD protein, specifically intended for intravenous use. This novel formulation, which was developed and patented (pending) by Diamyd, is intended for patients with diseases that may benefit from GAD65 treatment, including Stiff Man Syndrome and other GAD-related movement disorders. The pre-clinical study was conducted by SNBL, a Seattle based clinical research organization.
Diamyd Medical is focused on developing treatments for diabetes, both Type 1 and Type 2, via GAD protein therapy. Its lead drug candidate, Diamyd, is designed to reduce the need of insulin injections and prevent the destruction of beta cells. The current Diamyd vaccine, which uses subcutaneous administration of rhGAD65, is being studied in two clinical trials -- (1) a double blind Phase IIb study of 70 children and adolescents; and (2) a Phase II/III study conducted in 160 adult type 2 diabetes patients with auto-antibodies to beta cells.
"Intact GAD65 is inherently not water soluble, which presents a challenge for developing a formulation that can be administered via the intravenous route," said John Robertson, Ph.D., Director of Research & Development. "Diamyd Medical has overcome this obstacle by developing this novel formulation that keeps GAD65 active in the bloodstream and avoids precipitation. More importantly, the results obtained in this pre-clinical study indicate that the new formulation should be safe to use via an intravenous (IV) route of administration merits further clinical development."
About Diamyd Medical
Diamyd Medical is registered on the Stockholm Stock Exchange O List (OMX:DIAMB). An application has been submitted to trade the shares in the U.S. via a Level 1 ADR Program. The Company conducts therapeutic development based on its GAD (glutamic acid decarboxylase) technology platform. GAD is an enzyme that converts the excitatory neurotransmittor glutamate to the inhibitory transmittor GABA. In this context GAD may have an important role in CNS-related disease states. Recently Diamyd Medical announced the acquisition of Pittsburgh-based Nurel Therapeutics, which broadens Diamyd's pipeline with candidate drugs for CNS and nervous disease. GAD is also a target pancreatic beta cell autoantigen in autoimmune diabetes, such autoimmunity leading to development of insulin-dependence. Diamyd Medical's furthest developed project is Diamyd, which is currently employed in two ongoing clinical trials of both Type 2 and Type 1 diabetes which are follow-ons of first successful dose finding Phase II trial which is now in an open follow up phase.
Diamyd Medical AB (publ). Linnegatan 89 B, SE-115 23 Stockholm, Sweden. Tel: 08-661 00 26, fax: 08-661 63 68 or email: info@diamyd.com. Corp ID: 556530-1420.
This information includes statements concerning historical, present and forward-looking items and is to the "best of knowledge" of the management of Diamyd Medical and the actual status and results achieved by the Company may differ materially from these statements. The Company assumes no obligation to update these statements to reflect actual results, changes in assumptions or changes in other factors affecting such statements. The Company's Press Releases, Quarterly Reports and Annual Reports ("Information") are translations from the Swedish originals. No guarantees are made that the translation is free from errors.