BioWorld International Correspondent

Shares in Diamyd Medical AB gained almost 10 percent on news that the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is planning to undertake a Phase IIb clinical trial of Diamyd, its therapeutic vaccine for Type I diabetes.

The study, under principal investigator Jerry Palmer, professor of medicine at the University of Washington in Seattle, is being carried out under the auspices of the National Institutes of Health-sponsored TrialNet, a global network of 18 clinical centers, which is linked to another 100 collaborating sites.

The "assembled expertise" includes most of the Western world's "key opinion leaders" in diabetes, Diamyd CEO Anders Essen-Möller told BioWorld International. "It's really a quality stamp. There are so many projects out there, and they believe this is worth looking into."

The trial will recruit 126 patients, ages 8 to 45 years, who have been diagnosed with insulin dependent Type I diabetes mellitus within the previous three months. Patients will be assigned to one of two dose arms or a placebo group, according to details of the study that have been posted on the clinicaltrials.gov website under the identifier NCT00529399.

The study is intended to determine whether treatment with Diamyd, a recombinant form of the enzyme glutamate decarboxylase (GAD-65), will preserve insulin production in newly diagnosed Type I diabetes patients. GAD-65 is a major auto-antigen in Type I diabetes, and the vaccine, which is adjuvanted with alum, is designed to elicit immunological tolerance in patients and thereby retard the autoimmune destruction of insulin-secreting beta cells.

Stockholm, Sweden-based Diamyd already has completed a Phase II clinical trial, and "it looks great," Essen-Möller said. "You give two injections, and you can see an effect after 15 months in new onset patients." It has a similar effect to immunosuppression, he said, without the attendant risks of the latter.

Diamyd is planning to move the vaccine into a Phase III clinical trial shortly, on both sides of the Atlantic. "We plan to file an IND this year," Essen-Möller said. It would take around three years to complete a Phase III program, he said.

Diamyd licensed the vaccine from inventors Allan Tobin and Daniel Kaufman at the University of California, Los Angeles, who published their discovery of the role of GAD-65 in Type I diabetes in the early 1990s. The supporting patent estate was granted in 1995 and does not expire until 2021, Essen-Möller said. The company could seek further extensions beyond that date.

Diamyd reported SEK81.6 million in cash at May 31, and the company currently is exploring options for additional funding and seeking a partner, Essen-Möller said.

GAD-65, which catalyzes the conversion of the excitatory neurotransmitter glutamate to the inhibitory neurotransmitter gamma-amino butyric acid (GABA), also has potential in several central nervous system (CNS) conditions. Diamyd already has out-licensed rights in Parkinson's disease to Neurologix Inc., of Fort Lee, N.J.

It is planning to conduct a Phase I clinical trial in pain later this year. It is targeting nerve cells directly, using a replication-deficient herpes virus, termed the nerve targeting drug delivery system, which it licensed from the University of Pittsburgh,

Diamyd shares (Stockholm:DIAMB) closed at SEK92.25 Friday, up from the previous day's close of SEK84, and edged up to close at SEK94 on Monday. The shares were trading at SEK155 earlier in the year, before the company had to jettison efficacy data from a Phase II/III study of Diamyd in Latent Autoimmune Diabetes in Adults, following handling errors on the part of the CRO that invalidated the study. (See BioWorld International, June 20, 2007.).

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