Diamyd Reports Promising Safety Findings from Phase I Study in Chronic Pain
To date no drug related Serious Adverse Events have been reported by any patient included in Diamyd's Phase I clinical trial investigating NP2 as a potential therapy for chronic pain. Based upon the Phase I findings to date, the company is planning a multi-center, randomized, double-blind, placebo controlled Phase II clinical trial with NP2 in the United States.
"The Phase I trial is validating the safety of our entire neurology platform. That no drug related Serious Adverse Events have been observed strengthens our confidence in the platform and the potential it has in cancer pain and other indications", says Elisabeth Lindner, CEO and President of Diamyd Medical.
The Phase I study is intended to test the safety of NP2, the first drug candidate from the Company's proprietary NTTDS (Nerve Targeting Drug Delivery System) platform. NTDDS is focusing on delivery of therapeutic compounds directly to the nervous system. The indication studied in Phase I is cancer pain for which NP2 has been engineered to deliver the natural opioid Enkephalin. The clinical trial is designed as an open label, dose escalation study in patients with intractable pain due to malignancy. Trial results should be available in the near future as data is currently being collected on the final patient projected to be enrolled in the study.
"Contrary to systemic treatment such as morphine, NTDDS delivers the drug focally, specifically to the nerves experiencing pain which is a major advantage for the wellbeing of the patient," states Darren Wolfe, President of Diamyd Inc., the US subsidiary of Diamyd Medical responsible for the development of NP2 and the NTDDS platform.
David Fink, M.D., Professor and Chairman of the Department of Neurology, University of Michigan, Ann Arbor, Lead Investigator of the Phase I study, is presenting the study today at the Annual Meeting of the Neurological Association in San Francisco.
"I am very pleased with how the study has advanced and excited about the potential to maybe be able to help many patients in the future," says Dr. Fink. “Over 4 million cancer patients in the US experience severe pain, representing a large unmet medical need."
For more information, please contact:
Elisabeth Lindner, President and CEO Diamyd Medical AB (publ.)
Phone: +46 8 661 0026
For pictures and press material, please contact:
Andreas Ericsson, Diamyd Medical AB (publ.)
andreas.ericsson@diamyd.com
Phone: +46 8 661 0026
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 2010 the company signed an agreement with Ortho-McNeil-Janssen Pharmaceuticals, Inc., a Johnson & Johnson company, to develop and commercialize the Diamyd® diabetes therapy. 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.
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.)
Karlavägen 108, SE-115 26 Stockholm, Sweden. Tel: +46 (0)8 6610026, Fax: +46 (0)8 661 63 68
E-mail: info@diamyd.com. VAT no: SE556530-142001.
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