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 (andreas.ericsson@diamyd.com)
Phone: +46 8 661 0026
