Novogen gets FDA approval for Anisina orphan drug status
- Anisina is being developed to treat neuroblastoma, with a focus on children, as well as adults.
- Novogen is a U.S.-Australian biopharma company.
- The FDA granted orphan drug status to Novogen for Anisina based on the strength of preclinical data from studies conducted at the Children's Oncology Drug Alliance, The Kids' Cancer Project in Sydney, the University of New South Wales in Syndey and the Nationwide Children's Hospital in Columbus, Ohio.
So far, it's just preclinical studies, but the feedback has been positive. In preclinical studies, Anisina significantly improved the effectiveness of vincristine, a microtubule-targeting compound, which is the standard of care in patients with neuroblastoma. Novogen has looked at Anisina as monotherapy and also as combination therapy with vincristine in animal models, and both have been effective.
The company is also looking at Anisina in various combinations with other microtubule-targeting compounds. Clinical studies with human adult patients are expected to start in mid-2016, and by early 2017, Novogen expects to start studying Anisina in children in both the U.S. and in Australia.
- Pharmaceutical Business Review Novogen gets FDA orphan drug status for Anisina to treat neuroblastoma