STOCKHOLM, Sweden, Dec. 15 /PRNewswire-FirstCall/ -- Diamyd Medical AB (SWEDEN NOMX: DIAM B; US ADR: DMYDY) announced today that it is submitting a Pre-IND/ End of Phase II Briefing Package with the United States Food and Drug Administration relating to a proposed type 1 diabetes clinical trial in the US. The Briefing Package is submitted in support of a meeting with the agency scheduled for January 29, 2007 in Washington DC. Both the Briefing Package and the Pre-IND/End of Phase II Meeting are important first steps in the process for seeking approval to conduct clinical studies in the US.
"We look forward to opening the dialog with the FDA regarding the potential initiation of our clinical program for Diamyd(R) in the US," stated Anders Essen-Moller, CEO of Diamyd Medical. "We obviously cannot predict the outcome of any meeting with the regulatory authorities, but we hope we will gain some valuable guidance towards structuring a suitable US clinical program for the continued development of Diamyd(R) as a therapy for type 1 diabetes."
About Diamyd Medical
Diamyd Medical is a Life Science company focused on developing treatments for diabetes and its complications. The Company's furthest developed project is the GAD-based drug Diamyd(R) for autoimmune diabetes. Diamyd(R) has demonstrated significant and positive results in Phase II clinical trials of both type 1 and autoimmune type 2 diabetes patients (LADA) in Sweden.
GAD65 is a major autoantigen in autoimmune diabetes and the active substance in Diamyd(R). GAD65 is also an enzyme that converts the excitatory neurotransmitter glutamate to the inhibitory transmitter GABA. In this context GAD may have an important role not only in diabetes, but also in several CNS- related diseases. Diamyd Medical has an exclusive world-wide license from UCLA in Los Angeles regarding the therapeutic use of the GAD65 gene.
Diamyd Medical has sublicensed its UCLA GAD65 Composition of Matter license to Neurologix Inc., New Jersey, for treatment of Parkinson's disease with an AAV-vector.
Other projects comprise drug development within gene therapy using the exclusively licensed Nerve Targeted Drug Delivery System (NTDDS). The NTDDS is niched to deliver therapeutic genes to nervous tissue. The Company's lead gene therapy projects include using Enkephalin and GAD for chronic pain, e.g., diabetes pain or cancer pain. All projects in this field are in preclinical phases.
Diamyd Medical has offices in Stockholm (Sweden) and in Pittsburgh (U.S.A.) and its shares are quoted at the Nordic Exchange (NOMX: DIAM B). The Diamyd share is also traded in the US through a Level 1 ADR program administered by the Bank of New York . Further information is to be found on the Company's website; www.diamyd.com.
For further information, please contact: Anders Essen-Moller President & CEO Tel: +46 8 661 0026 Cell: +46 7 0551 0679 E-mail: anders.essen-moller@diamyd.com For media in the U.S.A. please contact: Gregory Tiberend Executive Vice President Richard Lewis Communications, Inc. Tel: +1 212 827 0020 E-mail: gtiberend@rlcinc.com
Diamyd Medical AB (publ). Linnegatan 89 B, SE-115 23 Stockholm, Sweden. Tel: +46 8 661 00 26, fax: +46 8 661 63 68 or E-mail: info@diamyd.com. VATno: SE556530-142001.
This Information may include statements concerning historical, present and forward-looking items and are to the "best of knowledge" of the management of Diamyd Medical and the actual status 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 Swedish originals. No guarantees are made that these translations are free from errors.
Diamyd MedicalCONTACT: Anders Essen-Moller, President & CEO, +46-8-661-0026, Cell:+46-7-0551-0679, anders.essen-moller@diamyd.com; or Gregory Tiberend,Executive Vice President, Richard Lewis Communications, Inc.,+1-212-827-0020, gtiberend@rlcinc.com
Web site: http://www.diamyd.com/
