DIAMYD CONTINUES INVALIDATED STUDY
Press Release, Stockholm, Sweden, June 19, 2007 - Diamyd Medical AB
(www.omxgroup.com, ticker: DIAM B; www.otcqx.com, ticker DMYDY)
Diamyd Medical reports that the Company plans to apply to continue the study in
160 LADA patients, which was invalidated after concerns of a mix up between
active drug and placebo. After deliberations with Professors Åke Lernmark and
Carl-David Agardh at Malmo University Hospital, Sweden, it was concluded that
the study can still bring valuable information. Completing the study does not
involve any material extra costs for the Company.
”The decision to invalidate the study might seem like a harsh decision”, says
Anders Essen-Moller, CEO of Diamyd Medical. “However, we do not, and we can not,
allow any compromises when it comes to keeping the highest standard of quality
in our studies. A suspicion that a mistake has been committed is thus an issue
which must be addressed forcefully and with determination.”
Diamyd Medical, in consultation with Professors Carl-David Agardh and Åke
Lernmark, now plans to apply to continue the study. “Important information may
still be collected from the study. We owe this to the participating patients”,
says Essen-Moller. “Next week for example, Diamyd Medical participates in an
international meeting in Chicago which among other things discusses the normal
development of the beta cell function in LADA patients and it will be
interesting to see what this brings.”
The reason to continue the study is to continue building the safety database for
Diamyd®. No serious adverse event related to Diamyd-treatment has occurred in
any study including the current LADA study.
Diamyd Medical had HbA1c as endpoint in the LADA study. This was the endpoint
considered accurate when designing the study. Meal stimulated insulin secretion,
measured as stimulated C-peptide, was not an FDA approved endpoint at the time.
Diamyd Medical was in January 2007 the first to receive FDA agreement to
evaluate beta cell function using meal stimulated insulin secretion (measured as
stimulated C-peptide) as endpoint, with certain conditions. HbA1c is a long term
average blood sugar parameter. As LADA patients are insulin resistant they
receive blood glucose reducing agents (insulin sensitizers) and their HbA1c
values will be treated to near normal. Therefore the additional HbA1c effect
from Diamyd® that is given to treat autoimmunity may be less pronounced in well
treated patients, while the insulin secretion capacity is improved.
Type 1 Diabetes
In August 2006, the Company reported a successful phase II study with Diamyd®.
In this study, 70 recent onset type 1 diabetes patients were treated with two
injections of Diamyd® or placebo and the Diamyd® group showed significantly
higher meal stimulated insulin levels than the placebo group. In addition,
Diamyd®-treated patients showed a clear favorable immune response.
Development Timeline
Diamyd Medical plans to initiate phase III studies for the type 1 diabetes
indication in about six months. “We believe that once the phase III studies are
ongoing for type 1 diabetes, a small additional study in LADA patients may
suffice to broaden the application for LADA-patients,” says Essen-Moller. “For
that reason we will continue to work on both the type 1 diabetes and the LADA
indications.”
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 worldwide 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.
