Revolutionary Immunologic Data Explains Function of Diamyd Diabetes Vaccine
Diamyd Medical AB (www.omxgroup.com ticker: DIAM B; www.otcqx.com ticker DMYDY)
STOCKHOLM, Sweden, May 3, 2007 – 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.
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.
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.
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
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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.
Posted: May 2007
