Avicena compound gets orphan drug designation for Huntington's disease

By Elaine Rigoli

Tampa, Fla., March 22 - The Avicena Group, Inc. said the Food and Drug Administration has granted orphan drug designation to HD-02, the company's proprietary drug candidate for the treatment of Huntington's disease, a progressive neurodegenerative disease caused by a defective gene.

Orphan drug designation typically results in expedited FDA marketing review times as compared to other drugs.

The company recently announced the publication of positive phase 1/2 data for HD-02 in the journal Neurology.

The findings showed that the drug was safe and well-tolerated by patients at a dose of eight grams/day, while resulting in elevated serum and brain levels of creatine, according to a news release.

Additional findings demonstrated that HD-02 reduced serum 8-hydroxy-2'-deoxyguanosine (serum 8OH2'dG) levels, which are markedly elevated in Huntington's disease patients, the release said.

Some researchers believe that this decrease in serum 8OH2'dG may suggest reduced oxidative injury in patients with Huntington's disease.

The study's investigators intend to use the findings from this trial to design late-stage studies of HD-02 aimed at examining the drugs' ability to slow or halt the progression of Huntington's disease.

Based in Palo Alto, Calif., Avicena is a biotechnology company that seeks to develop and commercialize therapeutic products that regulate the critical energy processes that occur within human cells.

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