Diamyd Medical AB reports that a Phase II study evaluating the Company’s drug
candidate NP2 Enkephalin did not meet its primary objective of reducing pain in
subjects with severe intractable cancer pain. The treatment was however well
tolerated, confirming the safety of the Company’s NTDDS technology.
The purpose of the randomized, double-blind, and placebo-controlled Phase II
study is to evaluate the effect of intradermal injection of NP2 Enkephalin on
pain reported by subjects suffering from severe intractable pain due to cancer,
as well as to confirm the safety of the treatment. The study includes a total of
33 adult subjects, 17 randomized to receive NP2 Enkephalin and 16 randomized to
the placebo group. It is being conducted at 18 clinics in the United States. It
is the first placebo-controlled clinical trial of a drug candidate based on
Diamyd Medical’s patented Nerve Targeting Drug Delivery System (NTDDS), a gene
based technology for delivery of therapeutics directly to the nervous system.
An initial analysis of the results from the 28 day double-blind main study
period shows that during day 3 to 14 following a single dose of study drug, the
group that received NP2 Enkephalin reported on average no better improvement in
pain score than the placebo treated group. Pain scores are reported daily by the
study subjects applying a numerical rating scale from 0 to 10. The treatment has
been well tolerated, as demonstrated by a comparable number of serious adverse
events in the two treatment groups, and the fact that no serious adverse events
have been deemed related to the treatment. Data continues to be collected from
an open label extension period of the study where subjects have received up to
two additional doses of NP2 Enkephalin. All the subjects also receive
conventional pain therapy throughout the study, including opiate drugs.
“Although we had hoped for a better outcome regarding pain relief in this study,
we note that the treatment appears safe which is an important finding for the
whole NTDDS platform,” says Peter Zerhouni, President and CEO of Diamyd Medical.
“We will continue our analysis of this study, including subgroups and the data
from the open label extension period, to determine how to adapt the development
plan for our NTDDS portfolio of drug candidates addressing diseases and symptoms
within the nervous system which today cannot be adequately treated. I would also
like to use this opportunity to thank all the study participants as well as the
investigators and study staff who dedicate themselves to the conduct of this
study.”
NP2 Enkephalin is based on the NTDDS platform and delivers the natural
painkilling substance enkephalin directly to the nervous system for the
treatment of pain. Substantial and sustained pain relief has previously been
observed in a clinical Phase I study (Fink et al. Annals of Neurology
2011;70:207–212) as well as in numerous preclinical models.
“The lack of efficacy in the double-blind part of this study is unexpected given
the robust preclinical data and the encouraging results from the previous Phase
I study with NP2 Enkephalin,” says Darren Wolfe, President of Diamyd, Inc., the
US subsidiary of Diamyd Medical carrying out the research and development of the
NTDDS platform. “However, we are still in the early days of exploring the NTDDS
technology in man and the concept of nerve targeted gene delivery can remain
valid despite failing to demonstrate efficacy in this relatively small trial.
Clinical development in intractable pain in subjects with advanced cancer is a
challenging indication on many levels. That the technology appears safe in this
trial will expand our development options and other indications may prove better
targets for this therapeutic approach, be it with NP2 Enkephalin or other drug
candidates from our NTDDS platform.”
For more information, please contact:
Peter Zerhouni, President and CEO Diamyd Medical AB
Phone: +46 8 661 00 26. E-mail: press@diamyd.com
About the NTDDS platform
Diamyd Medical’s Nerve Targeting Drug Delivery System (NTDDS) is an innovative
technology for the delivery of therapeutics directly to the nervous system and
forms the basis of the Company’s development projects within pain and
neuropathy. The NTDDS technology aims to provide a local effect in the parts of
the body where the treatment is targeted without affecting the rest of the body.
The NTDDS platform comprises three drug candidates for the treatment of various
forms of chronic pain; NP2 Enkephalin, NG2 GAD, NE2 Endomorphin and one drug
candidate for the prevention of chemotherapy induced peripheral neuropathy, NN1
Neurotrophin.
Diamyd Medical´s NTDDS-based drug candidates consist of a vector which carries a
gene for a therapeutic substance, e.g., a painkilling substance. The drug is
injected into the skin, where the vector and the gene are taken up by nerve
endings and then transported along the body’s peripheral nerve pathways to nerve
cell bodies that lie just outside the spinal cord. Here the nerve cell’s own
processes are being used to continuously produce the therapeutic substance with
the gene as template. Since it is gene-based, a single dose can provide a
relatively long-term therapeutic effect that may last several weeks to months.
As the treatment acts locally, systemic drug exposure is limited, a fact that
may significantly reduce the risk of side effects.
The technology has a wide potential and may be used for the treatment of several
different diseases and symptoms in the peripheral and central nervous system
such as chronic pain, neuropathy (nerve damage), cancer and neurodegenerative
diseases. Research and development on the NTDDS platform is primarily carried
out by the subsidiary Diamyd, Inc. located in Pittsburgh, USA.
About Diamyd Medical
Diamyd Medical is a Swedish biotech company focusing on the development of
pharmaceuticals for the treatment of pain, neuropathy and diabetes. The
development projects for the treatment of chronic pain and neuropathy uses the
Company’s patented NTDDS (Nerve Targeting Drug Delivery System) platform to
administer therapeutic agents directly to the nervous system. The development
project within the area of diabetes consists of the protein GAD65 for the
treatment and prevention of autoimmune diabetes. Diamyd Medical also has
holdings in the companies Protein Sciences Corporation (USA) and Mercodia AB
(Sweden).
Diamyd Medical has offices in Sweden and in the US. Shares are listed on Nasdaq
OMX (segment Small Cap) 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. Phone: +46 8 661 00 26, Fax: +46 8
661 63 68
E-mail: info@diamyd.com. Reg. no: 556530-1420
