Diamyd Starts Phase II Study in Cancer Pain
Diamyd has dosed the first subject in a Phase II clinical trial in the
United States evaluating the ability of the candidate drug NP2
Enkephalin to reduce cancer pain.
Diamyd's Phase II clinical trial with the candidate drug NP2 Enkephalin
will recruit approximately 32 subjects with severe cancer pain and
follow their pain scores and concomitant opioid pain medication usage.
It is a multi-center, randomized, double-blind, placebo controlled study
designed to provide a statistical evaluation of pain relief. The trial
has a four week double-blind main study period and following this
period, all patients will be offered up to two additional doses of
active NP2 Enkephalin in an open label study extension. The open label
study extension will measure pain scores following repeat dosing as well
as provide additional safety evaluations.
"Based on the encouraging results of the Phase I trial investigating NP2
Enkephalin as a potential therapy for chronic pain, Diamyd has been able
to rapidly initiate this new study in cancer patients with chronic
severe pain", states Darren Wolfe, CEO of Diamyd Inc., the US subsidiary
of Diamyd Medical.
Diamyd has previously announced that substantial and sustained reduction
in pain scores were reported in its Phase I clinical trial intended to
test the safety of NP2 Enkephalin and the Company's Nerve Targeting Drug
Delivery System (NTDDS) in patients with intractable pain due to cancer.
No treatment related Serious Adverse Events have been observed in the
Phase I study to date.
"The serious unmet medical need of efficient pain relief is a strong
driver for our team to continue development of NP2 Enkephalin and the
NTDDS platform", says Elisabeth Lindner, CEO and President of Diamyd
Medical. "With the Phase II study Diamyd intends to show
proof-of-concept for the NP2 Enkephalin treatment, which is the furthest
advanced project in our portfolio of pain-relieving drug candidates
based on the proprietary NTDDS platform."
NTDDS represents a new class of pharmaceutical products that delivers
gene-based drugs directly to nerve cells, providing a direct effect in
the cells targeted by the treatment. The drug candidate NP2 Enkephalin
has been engineered to deliver the human Enkephalin gene, which
naturally produces opioid peptides involved in pain control, directly to
the site of pain in the peripheral nervous system.
"In preclinical studies, vector-mediated gene delivery has been shown to
be effective in models of inflammatory pain, including arthritis pain,
and pain from nerve damage due to injury or diabetes in addition to
cancer pain. This Phase II clinical trial is an incredibly important
step not only for cancer pain, but for establishing proof-of-principle
in patients for this approach to treating pain", says David Fink, MD,
Robert Brear Professor and chair of the department of neurology at the
University of Michigan, and lead investigator of the trial.
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
