Positive data from Phase I study with antipain candidate NP2 enkephalin was reported this week.

Swedish pharmaceutical firm Diamyd Medical is restructuring its operations into two distinct business areas, diabetes and pain, to help give greater visibility to its pain portfolio. The diabetes unit comprises the Phase III-stage antigen-based therapy Diamyd®, which is being developed in partnership with Ortho-McNeil-Janssen Pharmaceuticals.

The pain portfolio, perhaps overshadowed to date by Diamyd Medical’s lead diabetes candidate, includes the early clinical-stage drug NP2 enkephalin along with preclinical candidates NG2 GAD and NE2 endomorphin. Positive data from a Phase I trial with NP2 enkephalin were reported earlier this week.

“We have decided to divide our operations in order to highlight our pain portfolio,” comments Elisabeth Lindner, president and CEO. “We see a great medical need and an opportunity to quickly demonstrate the value of our pain portfolio by continuing our cancer pain program with N22 enkephalin.”

Diamyd’s pain portfolio is based on its NTDDS (nerve-targeting drug delivery system) gene therapy platform, which is designed to deliver the gene for a therapeutic molecule directly to nerve cells, bypassing the bloodstream. Administered by intradermal injection, the vector is delivered into the peripheral nervous system to reside just outside the spinal cord, where the delivered gene is expressed to block pain signals to the brain, Diamyd explains.

The same principal is being applied for the potential treatment of glioma by using the NTDDS technology to deliver cell-killing substances directly to the tumor. Research on the NTDDS platform is carried out primarily at the firm’s U.S. facility.

Diamyd’s existing NTDDS products include candidates NP2 enkephalin, NG2 GAD, and NE2 endomorphin for treating chronic pain and NC3 for the treatment of brain cancer.

Earlier this week the firm reported positive data from a dose-ranging, Phase I trial evaluating NP2 enkephalin in the treatment of chronic cancer pain. Study data showed the treatment resulted in substantial and sustained reductions in pain scores among patients receiving the middle and high doses of NP2. A Phase II study is now being planned.

The firm’s Diamyd products are GAD-based vaccines for treating type 1 diabetes and latent autoimmune diabetes in adults (LADA). The type 1 diabetes candidate is a GAD65 antigen-based vaccine. It is currently undergoing Phase III trials in Europe and the U.S. Results from the studies are expected by the end of 2010. GAD65 is a major autoantigen in autoimmune diabetes, and Diamyd’s pipeline is based on the 65 kDa isoform of the recombinant human glutamic acid decarboxylase protein, isoform 65 kDa (rhGAD65), the company notes.

Diamyd is also being developed to prevent LADA patients from becoming insulin dependent and is currently in Phase II evaluation. The firm says LADA patients are typically adults who are distinct from type 2 diabetes patients due to elevated levels of antibodies to GAD.

In June Diamyd Medical signed a global development and commercialization deal for Diamyd with Ortho-McNeil-Janssen Pharmaceuticals. The company received a $45 million up-front payment and is  eligible to additional milestones of up to $580 million plus sales royalties. Under terms of the agreement the firm has retained exclusive commercialization rights to the product in Nordic countries.

It also retains rights to therapeutic uses of the GAD65 gene and derivatives, fragments, and variants of the GAD65 protein. Application of the GAD65 gene in the potential treatment of Parkinson disease was previously licensed out on a nonexclusive basis to Neurologix.

Previous articleAstellas and Cardiome Halt Enrollment in Phase IIIb AF Trial Following Cardiogenic Shock
Next articlePivotal Study Finds Novartis Adjuvanted Flu Vaccine 89% Effective in Infants and Children