Diamyd Medical: Diamyd Files US IND For Phase I Trial With Novel Chronic Pain Therapy

Main Category: Pain / Anesthetics
Also Included In: Clinical Trials / Drug Trials
Article Date: 14 Jan 2008 - 2:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

Diamyd Medical announces that it is submitting an IND for NP2, the company's first drug candidate in its Nerve Targeting Drug Delivery System (NTDDS) gene therapy platform, to the US Food and Drug Administration (FDA). Pending a favorable review by the agency, Diamyd plans to initiate a Phase I clinical study. NP2, developed by the company's U.S. subsidiary, Diamyd, Inc., produces enkephalin locally in the targeted sensory neurons to block pain signals before they are transmitted through the spinal cord to the brain. This may reduce or eliminate the need for systemic pain treatment and avoid associated side effects.

"We have made significant progress in advancing NP2, the first of several product candidates, towards the clinic", said Michael Christini, President of Diamyd, Inc. "With NP2, we have laid the groundwork for the rapid development of additional drug candidates such as the NTDDS-GAD product to treat pain in diabetes. The ability to deliver and express gene products directly in neurons that project into the spinal cord is extremely innovative and provides Diamyd with numerous possibilities to treat pain and other peripheral nervous system diseases."

The proposed Phase I clinical trial will be conducted at the University of Michigan in Ann Arbor. Dr. David Fink, Professor and Chair of the Department of Neurology, at the University of Michigan will be the principle investigator. The trial will be designed as a dose-escalation study to test the safety of NP2. In total 12 patients who suffer from severe cancer-related pain are planned to be enrolled with the option to expand the trial to enroll up to 24 patients pending the initial results.

"We are excited about the progress of the NTDDS program in Pittsburgh", says Elisabeth Lindner, CEO of Diamyd Medical. "Potential therapies for diabetes complications including neuropathic pain is of strategic interest for Diamyd Medical and complements nicely our Diamyd® diabetes vaccine, for which an application to initiate a Phase III trial was recently submitted to the FDA".

About Diamyd's NTDDS Technology for Treatment of Pain

Diamyd Medical owns the exclusive worldwide license rights to a portfolio of patents for the Nerve Targeting Drug Delivery System (NTDDS). This system is based on a replication incompetent viral delivery system that can express numerous therapeutic genes. The NTDDS has a natural affinity for nerve cells. Diamyd's initial NTDDS projects are focused upon peripheral and central nervous system applications. To that end, Diamyd seeks to combine the natural biology of the NTDDS (local nerve targeting) with therapeutic agents that are naturally found in the body and have a known therapeutic effect (e.g., GAD or enkephalin for treatment of pain, and neurotrophic factors for nerve damage). Thus, Diamyd believes that NTDDS proposes a new and broad class of nervous system disease therapies.

Pain is transmitted through a series of neurons that run from the skin to the brain. Pain signaling can be inhibited in several ways using the synapse between the peripheral and central nervous systems. This synapse provides input from the skin or organs as the first order neuron. The output from this synapse, the second order neuron, is within the spinal cord and projects into the brain to complete the pain pathway.

Three main compounds, enkephalins, GABA and endomorphins, naturally regulate pain transmission at the first order synapse. All these transmitters are expressed at some level in all synapses, however, depending on location in the body and the type of pain syndrome, there are differences in their effectiveness. For example, while GABA that is produced with the help of the GAD enzyme dampens spinal cord injury pain very well, enkephalin seems particularly well suited in treating cancer pain. The three independent systems for pain relieving may also be used together to create a synergistic effect.

Diamyd's NTDDS pain products will target patients who suffer from chronic pain caused by many diseases and conditions. In the United States, nearly one-third of the population experiences severe chronic pain at some point in life. According to the American Pain Society, only one in four patients with chronic pain receive adequate treatment. Approximately 1.7 million people in the United States and as many as 38 million worldwide suffer from moderate to severe neuropathic pain associated with back pain, diabetes, HIV/AIDS neuropathy, spinal cord injury, post herpetic neuralgia and trigeminal neuralgia. Incidence in the United States is anticipated to grow more than 5 percent annually due primarily to the greater rates of diabetes coupled with improved diagnosis. The neuropathic pain market is poorly served by current therapeutics and thus, is suitable for first-to-market products.

About Diamyd Medical

Diamyd Medical is a life science company developing treatments for diabetes and its complications. The company's furthest developed project is the GAD-based drug Diamyd® for autoimmune diabetes for which Phase III studies are planned. Diamyd® has demonstrated significant and positive results in Phase II clinical trials in Sweden.

GAD65, a major autoantigen in autoimmune diabetes, is the active substance in Diamyd. GAD65 is also an enzyme that converts the excitatory neurotransmitter glutamate to the inhibitory transmitter GABA. In this context, GAD may have an important role not only in diabetes but also in several central nervous system-related diseases. Diamyd Medical has an exclusive worldwide license from the University of California at Los Angeles regarding the therapeutic use of the GAD65 gene.

Diamyd Medical has sublicensed its UCLA GAD Composition of Matter license to Neurologix, Inc. in Fort Lee, New Jersey for treatment of Parkinson's disease with an AAV-vector.

Other projects comprise drug development within therapeutic gene transfer using the exclusively licensed and patent protected Nerve Targeted Drug Delivery System (NTDDS). The company's lead NTDDS projects include using enkephalin and GAD for chronic pain, e.g., diabetes pain or cancer pain. All projects in this field are currently in preclinical phases.

Diamyd Medical has offices in Stockholm, Sweden and Pittsburgh, PA. The Diamyd Medical share is quoted on the Stockholm Nordic Exchange in Sweden (NOMX ticker: DIAM B) and on the OTCQX-list in the United States (ticker: DMYDY) administered by the Pink Sheets and the Bank of New York (PAL). Further information is available at http://www.diamyd.com.

Disclaimer: This document contains certain "statements" relating to present understandings, future events and future performance, including statements relating to the progress, timing and completion of our research, development and clinical trials; our ability to market, commercialize and achieve market acceptance for product candidates; and our current and future strategic partner relationships. These statements can be affected by inaccurate assumptions or by known or unknown risks and uncertainties. Diamyd Medical undertakes no obligation to publicly update such statements, whether because of new information, future events or otherwise, nor does Diamyd Medical give any guarantees that the statements, given or implied, are correct. This document is a translation from the Swedish original. No guarantees are made that the translation is free from errors.

Diamyd Medical