REVOLUTIONARY IMMUNOLOGIC DATA EXPLAINS FUNCTION OF DIAMYD DIABETES VACCINE
Press Release, Stockholm, Sweden, May 3, 2007 - Diamyd Medical AB
(www.omxgroup.com ticker: DIAM B; www.otcqx.com ticker DMYDY)
During a presentation made in Linkoping, Sweden at the Sweden-Seattle Diabetes
Conference this past week-end, Professor Johnny Ludvigsson, the Principal
Investigator in Diamyd's previously reported successful Phase II study in type 1
diabetes, presented potentially scientifically ground-breaking results from a
recently completed analysis of the immunological data from the same trial.
The phase II type 1 clinical trial reported positive 15-month clinical results
in August 2006. The study was a double blind, randomized and placebo controlled
trial that included 70 young type 1 diabetes patients. The patients received two
injections, four weeks apart, of either 20 µg Diamyd® or placebo. Since this was
a double-blinded study, the code containing information on which patients
received the Diamyd® vaccine and which patients received placebo was not
“unlocked” until 15 months after study initiation.
Vaccination with Diamyd® Counteracts Destruction of Insulin Producing Cells
In addition to analysing clinical outcome of Diamyd®, immunological tests were
also conducted by the Linkoping team according to international scientific
standards. These immunological data was subject to rigorous biostatistical
analysis.
At the Conference, Professor Ludvigsson presented startling data based on the
immunological analysis from the type 1 diabetes trial. The data illustrates that
virtually all patients treated with the Diamyd® therapeutic vaccine had an
upregulation of certain beneficial immunological markers in response to the
active ingredient in Diamyd®, which according to current opinion may counteract
the destruction of insulin producing beta cells by the immune system (the
so-called “autoimmune attack”). These immunological markers remained upregulated
even 15 months after the first injection, while patients that received placebo
showed a downregulation of the same markers over time. Accumulation of
scientific evidence has long pointed to GAD65, the active ingredient of Diamyd®,
as a possible “immunomodulator” that could prevent the immune system from
destroying the insulin producing beta cells.
Immunological Findings Consistent with Expectations Explains Positive Clinical
Results
Professor Ludvigsson explained that the immunological data provided direct
confirmation of the positive clinical results obtained in August 2006. They
demonstrated that treatment close to disease onset provided a better clinical
effect than a later in time administration of the vaccine. The new immunological
findings indicate that virtually all Diamyd® treated patients, regardless of
disease duration, responded immunologically, but that the clinical effect of
arresting the autoimmune attack that destroys beta cells close to disease onset
is superior to a later intervention when the patient's beta cells have been
almost totally destroyed.
“This may be a breakthrough in diabetes research”, says Professor Johnny
Ludvigsson. “There is no doubt that the GAD-vaccine has had positive effects.
And it is a treatment that is very simple and without side effects. We have
previously reported that the earlier a patient is treated with Diamyd®, the
better are the chances that the endogenous insulin production will be preserved.
Now we can state that the treatment may be relevant also at a later stage as the
immunological effect observed may be a prerequisite to allow beta cell
regeneration or transplanted islets or stem cells to thrive without being
destroyed by recurrent autoimmune attacks.”
Potentially Groundbreaking Discovery.
“This is the first time it has been demonstrated that stimulating the immune
system with an autoantigen, such as GAD65, produces a lasting immunological
response, even up to 15 months after the initial vaccination”, stated Anders
Essen-Möller, President of Diamyd Medical. ”Moreover, the results are consistent
with what is expected according to the prevailing theory of how to treat
autoimmune disease. This means that the successful clinical effect of Diamyd®
administration is starting to be explained immunologically”.
Presentation of Additional Immunological Data and Type II Study Results.
Additional immunological data from the type 1 diabetes study will be presented
in the latter part of June at the American Diabetes Association Convention (ADA)
in Chicago. Importantly, results from a separate clinical study with the Diamyd
vaccine in 160 patients with autoimmune type 2 diabetes (LADA) are also planned
to be presented at the same ADA Convention.
Initiation of Phase III Clinical Trials.
Diamyd plans to initiate phase III studies in newly onset type 1 diabetics later
this year. The US study will take place under the direction of Professor Jerry
Palmer, and the Principal Investigator of the European study will be Professor
Ludvigsson.
For further information, please contact:
Stockholm-office
Anders Essen-Möller
CEO and President
Tel: +46 8 661 0026
E-mail: investor.relations@diamyd.com
Pittsburgh office
Michael Christini
President
Tel: +1 412 770 1310
E-mail: Michael.Christini@diamyd.com
For media contact in the US, please contact:
Gregory Tiberend
Executive Vice President
Richard Lewis Communications, Inc.
Tel: +1 212 827 0020
E-mail: gtiberend@rlcinc.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. Diamyd® has demonstrated significant and
positive results in Phase II clinical trials in both type 1 and autoimmune type
2 diabetes patients (LADA) 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 world-wide license from
the University of California at Los Angeles regarding the therapeutic use of the
GAD65 gene.
Diamyd Medical has sublicensed its UCLA GAD65 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 gene therapy using the
exclusively licensed and patent protected Nerve Targeted Drug Delivery System
(NTDDS). The company's lead gene therapy 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 in Pittsburgh (USA). The
Diamyd Medical share is quoted on the Stockholm Nordic Exchange in Sweden
(ticker symbol: DIAM B) and on the OTCQX-list in the US (ticker symbol: 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.
