DIAMYD FILES US IND FOR PHASE III TRIAL WITH DIABETES VACCINE
Press Release, Stockholm, Sweden, December 21, 2007 - Diamyd Medical AB
(www.omxgroup.com, ticker: DIAM B; www.otcqx.com, ticker DMYDY)
Diamyd Medical announced today that it has filed an Investigational New Drug
(IND) application for a pivotal US Phase III clinical trial with the Diamyd®
therapeutic vaccine in recent onset type 1 diabetes patients. The application
was submitted to the US Food and Drug Administration (FDA).
Similar applications for a parallel European Phase III trial are planned to be
submitted to European regulatory agencies. Diamyd Medical anticipates that two
successful Phase III studies, each comprising 300 recent onset type 1 diabetes
patients, may lead to market approval.
The Diamyd® therapeutic vaccine is intended to arrest or slow down the
autoimmune destruction of insulin producing beta cells in type 1 diabetes.
Diamyd® has demonstrated significant efficacy in Phase II clinical trials in
preservation of beta cell function for at least 21 months. Additionally, no
treatment-related serious adverse events have been observed, providing Diamyd®
with a strong safety profile.
“A newly diagnosed type 1 diabetes patient might face a lifetime of
complications from the disease despite conventional therapy with insulin
injections. In this context, Diamyd® has a remarkable potential as a novel
therapy filling a desperately unmet medical need,” says Elisabeth Lindner,
President and CEO of Diamyd Medical. “The filing of the Diamyd® IND and a
receipt of approval thereafter are prerequisites for conducting confirmatory
studies in larger patient populations in the US and important steps towards
making the Diamyd®-vaccine available to the patients.”
“Preservation of beta cell function in type 1 diabetes patients is an important
step towards finding a cure for type 1 diabetes and paving the way for beta cell
regeneration, stem cell and transplantation therapies,” says Professor Jerry
Palmer, Head of Diabetes Endocrinology Research Center at the University of
Washington in Seattle, US, who will take the role as lead investigator in the
planned US Phase III study. “Endogenous insulin production makes it easier for
the patients to manage their disease and there should be less late-stage
complications. I am proud to take Diamyd® to the next level.”
As previously announced, the Phase III trials will evaluate the effectiveness
and safety of Diamyd® in patients that have had type 1 diabetes for up to three
months. Based upon previous discussions with the FDA, meal-stimulated C-peptide,
as a correlate for the patient's own insulin production, will be the primary
endpoint. Insulin requirement and glycemic endpoints will also be measured and
results will be evaluated after 15 months.
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 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.
