DIAMYD® DIABETES VACCINE EFFECTIVE FOR AT LEAST 21 MONTHS
Press Release, Stockholm, Sweden, September 26, 2007 - Diamyd Medical AB
(www.omxgroup.com, ticker: DIAM B; www.otcqx.com, ticker DMYDY)
Diamyd Medical announced today that the statistically significant protective
effect of the experimental Diamyd® vaccine on insulin secretion in type 1
diabetes patients remains still 21 months after the first injection.
These results are presented today at the annual International Society for
Pediatric and Adolescent Diabetes (ISPAD) meeting in Berlin by Professor Johnny
Ludvigsson, Linkoping University, Sweden. Professor Ludvigsson is the Principal
Investigator for a Phase IIb study with the Diamyd® therapeutic diabetes vaccine
comprising 70 children with recent onset type 1 diabetes.
As previously reported, the 15-month results from this Diamyd® study
demonstrated that the Diamyd® treated group of 35 type 1 diabetes patients
experienced on average only half the decline in meal stimulated insulin
secretion, as measured by C-peptide, compared to the placebo treated group. The
statistically significant difference between treatment groups remains at 21
months (p=0.02), even though both groups continued to decline in stimulated
insulin secretion. The protective effect remains most pronounced in patients
treated shortly after diagnosis.
“These are amazing results”, says Professor Ludvigsson. “Only two injections
with the Diamyd® vaccine show lasting effects on insulin secretion still after
21 months. This is clinically important as it helps the children to better
control their disease and reduce long-term complications. It is also extremely
promising that the drug itself is very easy to administer and well tolerated. In
my view, there is no doubt that Diamyd® has a protective effect on residual
insulin secretion.”
As in all previously reported clinical studies with Diamyd®, no serious adverse
events associated with the therapy were observed during the 21-month follow up.
Final 30-month results are planned to be reported during the first quarter of
2008.
In a separate presentation at ISPAD, Professor Ludvigsson also reiterated his
and his team's previously reported immunological findings from the same study.
“These are also very exciting results”, says Professor Ludvigsson. “Still 15
months after treatment there is a highly statistically significant immunological
difference (p<0.0001) between patients treated with Diamyd® and placebo. This
demonstrates that Diamyd® vaccination has a lasting and specific effect on the
immune system which may be the reason for the protective effect seen on beta
cell function.”
As previously reported, Diamyd Medical is conducting partnership discussions
while simultaneously preparing its international Phase III program. In addition,
NIDDK and TrialNet are planning to conduct a separate trial with the
experimental Diamyd® vaccine to further investigate the correlation between the
clinical and immunological outcomes of Diamyd® treatment.
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 to
be initiated this year. 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.
