DIAMYD VACCINE DRUG SUBSTANCE PRODUCED - UPDATE ON DIAMYD PROGRESS
Press Release, Stockholm, Sweden, October 25, 2007 - Diamyd Medical AB
(www.omxgroup.com, ticker: DIAM B; www.otcqx.com, ticker DMYDY)
Diamyd Medical announced today that sufficient amounts of GAD65, the active
substance in the Diamyd® diabetes vaccine, for Phase III clinical trials have
been produced at Protein Sciences, Meriden, CT, and sent for testing.
Formulation and vialing is planned to take place in Europe in January 2008. The
Company plans to file its IND with the US FDA in December. This means that
approval to start the Phase III program can be granted during the 1st quarter
2008.
“While being a few months delayed in our preparations to start our Phase III
program, we are optimistic as sufficient amounts of GAD65 now have been
produced. Although testing of the substance is ongoing, our manufacturing
process has during the past four runs at scale, yielded consistent and
reproducible amounts. It has been a challenge to arrive at this, but now it
seems done” says Anders Essen-Moller, President of Diamyd Medical.
For further information, please contact:
Stockholm office
Anders Essen-Möller
CEO and President
+46 8 661 0026
investor.relations@diamyd.com
Pittsburgh office
Michael Christini
President
+1 412 770 1310
Michael.Christini@diamyd.com
Diamyd Medical AB (publ). Linnégatan 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.
About Diamyd Medical
Diamyd Medical is a life science company developing treatments for diabetes and
its complications. The company's furthest developed project is the GAD-based
drug Diamyd® for autoimmune diabetes for which Phase III studies are planned.
Diamyd® has demonstrated significant and positive results in Phase II clinical
trials in Sweden.
GAD65, a major autoantigen in autoimmune diabetes, is the active substance in
Diamyd. 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 central nervous
system-related diseases. Diamyd Medical has an exclusive worldwide license from
the University of California at Los Angeles regarding the therapeutic use of the
GAD65 gene.
Diamyd Medical has sublicensed its UCLA GAD Composition of Matter license to
Neurologix, Inc. in Fort Lee, New Jersey for treatment of Parkinson's disease
with an AAV-vector.
Other projects comprise drug development within therapeutic gene transfer using
the exclusively licensed and patent protected Nerve Targeted Drug Delivery
System (NTDDS). The company's lead NTDDS projects include using enkephalin and
GAD for chronic pain, e.g., diabetes pain or cancer pain. All projects in this
field are currently in preclinical phases.
Diamyd Medical has offices in Stockholm, Sweden and Pittsburgh, PA. The Diamyd
Medical share is quoted on the Stockholm Nordic Exchange in Sweden (NOMX ticker:
DIAM B) and on the OTCQX-list in the United States (ticker: DMYDY) administered
by the Pink Sheets and the Bank of New York (PAL). Further information is
available at www.diamyd.com.
Disclaimer: This document contains certain "statements" relating to present
understandings, future events and future performance, including statements
relating to the progress, timing and completion of our research, development and
clinical trials; our ability to market, commercialize and achieve market
acceptance for product candidates; and our current and future strategic partner
relationships. These statements can be affected by inaccurate assumptions or by
known or unknown risks and uncertainties. Diamyd Medical undertakes no
obligation to publicly update such statements, whether because of new
information, future events or otherwise, nor does Diamyd Medical give any
guarantees that the statements, given or implied, are correct. This document is
a translation from the Swedish original. No guarantees are made that the
translation is free from errors.
