publication date: Jul. 24, 2015
Drugs and Targets: Anisina Receives Orphan Designation in Neuroblastoma
FDA granted an Orphan Drug Designation to Anisina (ATM-3507) for neuroblastoma. Anisina is developed by Novogen Ltd.
The designation was based on data from preclinical studies which were done as part of the Children’s Oncology Drug Alliance involving Australian charity, The Kids’ Cancer Project, The University of New South Wales, The Nationwide Children’s Hospital of Columbus, Ohio, and Novogen.
The key findings from these studies showed that Anisina significantly improved the effectiveness of the standard of care microtubule targeting compound, vincristine, in an animal model of neuroblastoma. The data from these studies were recently announced and presented at Eighth Annual Cancer Molecular Therapeutics Research Association meeting in Boston.
Novogen is now conducting pre-clinical studies to further validate the combinatorial effect of Anisina with a range of microtubule-targeting compounds in animal models of adult cancer. Once the company has completed its pre-clinical toxicology program for Anisina, the drug is expected to enter the clinic for adults in mid-2016 with clinical trials in childhood cancer in Australia and the U.S. to follow in early 2017.
Amgen submitted a supplemental New Drug Application to the FDA for Kyprolis (carfilzomib) for Injection to seek an expanded indication for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy.
The sNDA is based on data from the global ENDEAVOR trial. ENDEAVOR is the first of two head-to-head phase III trials of Kyprolis versus Velcade (bortezomib).
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