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Kazia Therapeutics' brain cancer drug gets US FDA orphan drug tag


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Kazia Therapeutics' brain cancer drug gets US FDA orphan drug tag

Sydney's Kazia Therapeutics Ltd. said the U.S. Food and Drug Administration granted orphan drug designation for its investigational drug GDC-0084 for treating a type of brain cancer.

GDC-0084 is intended for patients with glioblastoma multiforme, the most common and aggressive form of primary brain cancer. The disease affects 130,000 people worldwide each year, with a median survival of 12 to 15 months for patients given the best available care.

The FDA grants orphan drug designation for drugs that show promise for treating rare diseases, or those that affect under 200,000 people yearly in the U.S. The designation can provide drug developers with up to seven years of exclusivity on the market, as well as opportunities for additional funding.

Kazia Therapeutics, formerly known as Novogen Ltd., licensed GDC-0084 from Roche Holding AG's Genentech Inc. in October 2016.

Kazia plans to start an international phase 2 study of the therapy in late March or early April.

Meanwhile, Kazia is also studying another drug, Cantrixil, in a phase 1 trial for patients with ovarian cancer. Initial results are expected in the first half of 2018.

In April 2017, Kazia terminated the development of its preclinical stage cancer drug Anisina to focus on GDC-0084 and Cantrixil.