Diamyd Medical and collaborators at the University of Michigan have been awarded a $3 million, three year NIH grant to develop a product based on the Swedish firm’s Nerve Targeting Drug Delivery System (NTDDS) for use in preventing chemotherapy-induced peripheral neuropathy. The aim is to develop an NTDDS candidate that delivers the gene for a neurotrophic factor directly to nerve cells. The product could then be administered to cancer patients before they start chemotherapy. The NIH grant will support preclinical efficacy, toxicology, and biodistribution studies with an NTDDS candidate, together with manufacturing and IND filing.
The award comes just weeks after Diamyd Medical confirmed that most of its employees in Sweden would be made redundant as a result of the failure of its lead diabetes candidate, Diamyd®, in pivotal trials. In August Phase III development of the GAD65-based candidate was formally discontinued, and Diamyd Medical said it would shift its focus onto its gene-delivering NTDDS platform for applications in chronic pain.
The NIH grant will enable the firm to expand utility of the platform into a new therapeutic area, comments Peter Zerhouni, Diamyd Medical’s president and CEO. “Expanding the application of the NTDDS technology from pain therapy to include the treatment and prevention of neuropathy is something we have foreseen for a long time. “With the nondilutive funding provided by the grant, we can take this step earlier than anticipated.”
Co-recipient of the NIH grant is the University of Michigan’s David Fink, M.D., a long-term collaborator on the NTDDS technology. “Treatment with NTDDS delivering a neurotrophic factor may not only prevent the development of chemotherapy-induced peripheral neuropathy, but may also allow more effective chemotherapy doses to be administered to the patient,” he adds.
Diamyd Medical’s existing NTDDS pipeline is focused on the treatment of chronic pain. Lead clinical-stage candidate, NP2 Enkephalin, is designed to deliver enkephalin directly to the nervous system, and is in Phase II development for the treatment of chronic cancer pain. A diabetes pain candidate, NG2 GAD, uses the NTDDS platform to deliver GAD locally to nerve cells. Preclinical studies supported by U.S. Department of Veterans Affairs grants are ongoing, and clinical studies are projected to start by year end. The firm’s third, also preclinical-stage NTDDS candidate, NE2 Endomorphin, uses the NTDDS platform to for the local, targeted delivery of endomorphin for treating neuropathic pain.
Diamyd Medical projects that in addition to its applications in the treatment of chronic pain and neuropathy, the NTDDS may also have applications in treating cancers of the nervous system, such as glioma, by transporting cell-killing substances directly to tumor tissue.