Diamyd makes investment in time-to-market
Diamyd Medical announces today that the company has signed an agreement with
Inclinix Inc., North Carolina, for accelerated recruitment of children and
adolescents recently diagnosed with type 1 diabetes in the US Phase III study of
the diabetes vaccine Diamyd®.
Diamyd Medical is conducting a global Phase III program with the diabetes
vaccine Diamyd®, including in total 640 children and adolescents with
recent-onset type 1 diabetes. The program is composed of one study in the US and
one parallel study in nine countries in Europe. The US recruitment effort will
soon be launched together with Inclinix Inc., under the name DIAPREVENT.
- Our agreement with Inclinix is performance based and targets to enable filing
for market approval in the US during 2011, which secures our time-to-market
projections for the Diamyd® vaccine, says Elisabeth Lindner, President and CEO,
The US Phase III study is rapidly expanding its number of sites from 13 to at
least 43 sites. The new sites are pediatric diabetes clinics for enrollment of
patients from 10 years of age. The highest incidence of type 1 diabetes is in
the age range 10-15 years. Inclinix has an excellent track record in patient
recruitment for type 1 diabetes in the US and is working through targeted
internet advertising, social media networking, professional regional recruitment
managers and regional referrals of patients to the study clinics.
- We are pleased that Diamyd Medical has chosen Inclinix as their enrollment
partner for this important study. We look forward to the opportunity to
contribute to the development of the Diamyd® vaccine and thereby make a truly
global impact on the pediatric medical community, says J. Tobin Geatz, President
and CEO, Inclinix.
The purpose of the study is to determine whether Diamyd® can preserve the body's
own insulin producing capacity in persons recently diagnosed with type 1
diabetes. Maintaining the insulin producing capacity could result in simpler
treatment and a better blood sugar balance, which in turn could reduce the risk
of both short-term and long-term complications typically associated with
For additional information, please contact:
Elisabeth Lindner, President and CEO Diamyd Medical AB (publ.)
Tel: +46 (0)8 661 0026
For pictures and press material, please contact:
Andreas Ericsson, Diamyd Medical AB (publ.)
Tel: +46 (0)8 661 0026
Inclinix, Inc. is a global enrollment Contract Research Organization (CRO)
specializing in customized Phase I - IV clinical trial enrollment solutions.
Inclinix services deliver productive investigative sites and qualified patients
for Sponsors, resulting in successfully completed clinical trials for the
pharmaceutical, biotech and medical device industries. Comprehensive enrollment
solutions include site recruitment, patient recruitment, clinical and medical
marketing communications, patient compliance and education, and the InSite
ScreenerT and InSite Patient TrackerT for comprehensive patient qualification
and retention. Since 1999, Inclinix (formerly PharmaTech Solutions, Inc.) has
participated in over 400 clinical trials in over 130 indications. Inclinix
corporate headquarters is located in Wilmington, North Carolina with additional
offices in Annapolis, Maryland, and Gothenburg, Sweden.
Kristin Sacre, Corporate Marketing Manager, Inclinix, Inc.
About Diamyd Medical
Diamyd Medical is a Swedish diabetes company focusing on
the development of pharmaceuticals for the treatment of autoimmune diabetes and
its complications. The company's most advanced project is the GAD-based drug
Diamyd® for type 1 diabetes. Phase III trials for this drug are in progress in
both Europe and the US. In addition, the company has initiated clinical studies
in the US in the area of chronic pain, using its Nerve Targeting Drug Delivery
System (NTDDS). The company has also out-licensed the use of GAD for the
treatment of Parkinson's disease. The company currently has three clinical-phase
Diamyd Medical has offices in Sweden and in the US. Shares are listed on Nasdaq
OMX in Stockholm (ticker: DIAM B) and on OTCQX in the US (ticker: DMYDY)
administered by the Pink OTC Markets and the Bank of New York Mellon (PAL).
Further information is available on the company's website: www.diamyd.com.
This information is disclosed in accordance with the Swedish Securities
Markets Act, the Swedish Financial Instruments Trading Act, or the requirements
stated in the listing agreements.
Diamyd Medical AB (publ.)
Linnégatan 89 B,
SE-115 23 Stockholm, Sweden. Tel: +46 (0)8 6610026, Fax: +46 (0)8 661 63 68
E-mail: email@example.com. VAT no: SE556530-142001.