DIAMYD FILES US IND FOR PHASE I TRIAL WITH NOVEL CHRONIC PAIN THERAPY
Stockholm, Sweden, and Pittsburgh, PA, USA, January 11, 2008 - Diamyd Medical AB
(www.omxgroup.com, ticker: DIAM B; www.otcqx.com, ticker DMYDY)
Diamyd Medical announces that it is submitting an IND today for NP2, the
company's first drug candidate in its Nerve Targeting Drug Delivery System
(NTDDS) gene therapy platform, to the US Food and Drug Administration (FDA).
Pending a favorable review by the agency, Diamyd plans to initiate a Phase I
clinical study.
NP2, developed by the company's U.S. subsidiary, Diamyd, Inc., produces
enkephalin locally in the targeted sensory neurons to block pain signals before
they are transmitted through the spinal cord to the brain. This may reduce or
eliminate the need for systemic pain treatment and avoid associated side
effects.
“We have made significant progress in advancing NP2, the first of several
product candidates, towards the clinic”, said Michael Christini, President of
Diamyd, Inc. “With NP2, we have laid the groundwork for the rapid development of
additional drug candidates such as the NTDDS-GAD product to treat pain in
diabetes. The ability to deliver and express gene products directly in neurons
that project into the spinal cord is extremely innovative and provides Diamyd
with numerous possibilities to treat pain and other peripheral nervous system
diseases.”
The proposed 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 principle 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
the initial results.
“We are excited about the progress of the NTDDS program in Pittsburgh”, says
Elisabeth Lindner, CEO of Diamyd Medical. “Potential therapies for diabetes
complications including neuropathic pain is of strategic interest for Diamyd
Medical and complements nicely our Diamyd® diabetes vaccine, for which an
application to initiate a Phase III trial was recently submitted to the FDA”.
About Diamyd's NTDDS Technology for Treatment of Pain
Diamyd Medical owns the exclusive worldwide license rights to a portfolio of
patents for the Nerve Targeting Drug Delivery System (NTDDS). This system is
based on a replication incompetent viral delivery system that can express
numerous therapeutic genes. The NTDDS has a natural affinity for nerve cells.
Diamyd's initial NTDDS projects are focused upon peripheral and central nervous
system applications. To that end, Diamyd seeks to combine the natural biology of
the NTDDS (local nerve targeting) with therapeutic agents that are naturally
found in the body and have a known therapeutic effect (e.g., GAD or enkephalin
for treatment of pain, and neurotrophic factors for nerve damage). Thus, Diamyd
believes that NTDDS proposes a new and broad class of nervous system disease
therapies.
Pain is transmitted through a series of neurons that run from the skin to the
brain. Pain signaling can be inhibited in several ways using the synapse between
the peripheral and central nervous systems. This synapse provides input from the
skin or organs as the first order neuron. The output from this synapse, the
second order neuron, is within the spinal cord and projects into the brain to
complete the pain pathway.
Three main compounds, enkephalins, GABA and endomorphins, naturally regulate
pain transmission at the first order synapse. All these transmitters are
expressed at some level in all synapses, however, depending on location in the
body and the type of pain syndrome, there are differences in their
effectiveness. For example, while GABA that is produced with the help of the GAD
enzyme dampens spinal cord injury pain very well, enkephalin seems particularly
well suited in treating cancer pain. The three independent systems for pain
relieving may also be used together to create a synergistic effect.
Diamyd's NTDDS pain products will target patients who suffer from chronic pain
caused by many diseases and conditions. In the United States, nearly one-third
of the population experiences severe chronic pain at some point in life.
According to the American Pain Society, only one in four patients with chronic
pain receive adequate treatment. Approximately 1.7 million people in the United
States and as many as 38 million worldwide suffer from moderate to severe
neuropathic pain associated with back pain, diabetes, HIV/AIDS neuropathy,
spinal cord injury, post herpetic neuralgia and trigeminal neuralgia. Incidence
in the United States is anticipated to grow more than 5 percent annually due
primarily to the greater rates of diabetes coupled with improved diagnosis. The
neuropathic pain market is poorly served by current therapeutics and thus, is
suitable for first-to-market products.
For further information, please contact:
Stockholm office
Elisabeth Lindner
CEO and President
+46 8 661 0026
investor.relations@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 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.
