DIAMYD RECEIVES FDA APPROVAL TO INITIATE CLINICAL STUDY IN CHRONIC PAIN
Press Release, Stockholm, Sweden, and Pittsburgh, PA, USA, February 15, 2008 -
Diamyd Medical AB (www.omxgroup.com, ticker: DIAM B; www.otcqx.com, ticker
DMYDY)
Diamyd Medical announced today that it has received approval from the U.S. FDA
to initiate a Phase I study in chronic pain using NP2, the company's first drug
candidate in its Nerve Targeting Drug Delivery System (NTDDS) gene therapy
platform.
NP2, developed by the company's U.S. subsidiary, Diamyd, Inc., in Pittsburgh,
produces enkephalin directly in sensory neurons to block pain signals before
they are transmitted through the spinal cord to the brain. Blocking pain with a
locally-targeted therapeutic in this fashion may reduce or eliminate the need
for conventional systemic pain treatment and thereby avoid associated side
effects.
“The quick and successful approval of the NP2 IND by the FDA is a great
milestone for the company”, said Michael Christini, President of Diamyd, Inc.
“We have now established a regulatory foundation upon which we can advance NP2
through the clinic and which can be easily replicated to benefit our other NTDDS
products such as GAD for treatment of neuropathic pain. The NTDDS platform
provides a whole new mechanism for therapeutic delivery of drugs to the nervous
system and we have great optimism that it will have broad application to the
benefit of Diamyd Medical and potential collaborators.”
“We are extremely pleased with the very favorable review the FDA has given our
IND filings for both the Diamyd® GAD diabetes drug and the NP2 chronic pain
product”, stated Elisabeth Lindner, CEO of Diamyd Medical. “This demonstrates
that Diamyd Medical now has a strong team in place that can advance both early
and late stage products into the clinic which will pay dividends as our pipeline
continues to grow and build shareholder value. We can now expect both trials to
start according to plan.”
The Phase I clinical trial will be conducted at the University of Michigan in
Ann Arbor. Dr. David Fink, Professor and Chair of the Department of Neurology,
at the University of Michigan will be the principal investigator. The trial will
be designed as a dose-escalation study to test the safety of NP2. In total 12
patients who suffer from severe cancer-related pain are planned to be enrolled
with the option to expand the trial to enroll up to 24 patients pending review
of initial results.
For further information, please contact:
Stockholm office
Elisabeth Lindner
CEO and President
+46 8 661 0026
elisabeth.lindner@diamyd.com
Stockholm office
Anders Essen-Möller
Chairman
+46 8 661 0026
anders.essen-moller@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 biopharmaceutical 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.
Other projects comprise drug development within therapeutic gene transfer using
the exclusively licensed and patent protected Nerve Targeting Drug Delivery
System (NTDDS). The company's lead NTDDS projects include enkephalin and GAD for
chronic pain, e.g., diabetes pain or cancer pain.
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.
