Novogen Limited (ASX:NRT) announced it has received notification from the US FDA that its chemotherapy candidate drug, ANISINA, has been granted Orphan Drug Designation for neuroblastoma.
Orphan Drug Designation is designed to encourage the development of experimental drugs for clinical indications that do not have a high incidence.
It can provide a number of benefits to the developer, including eligibility for US government grants to defray clinical trial costs, tax incentives for clinical research, waiver of US prescription drug filing fees, and enhanced marketing rights.
ANISINA was granted Orphan Drug Designation for neuroblastoma under the US Orphan Drug Act following a review by the FDA of a package of pre-clinical data submitted by Novogen.
The data is from preclinical studies which were done as part of the Children's Oncology Drug Alliance (CODA) involving Australian charity, The Kids' Cancer Project, The University of New South Wales, The Nationwide Children's Hospital in the US, and Novogen.
According to the company, 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 (CMTRA) meeting in Boston, USA.
Novogen Interim Chairperson, Ian Phillips said, "Obtaining the FDA approved Orphan drug designation for ANISINA is an important strategic achievement for us. It demonstrates the company's commitment to bringing a drug to market which we hope will improve the outcome for children with neuroblastoma. These incentives provided by the FDA have the potential to offset those significant costs associated with the clinical development of ANISINA."
