Andarix Receives Orphan Drug Designation from the FDA for Small Cell Lung Cancer
Novel Targeted and Personalized Medicine Approach to Lung Cancer
ANDARIX Pharmaceuticals, a leader in the discovery and development of targeted peptide therapy for lung and neuroendocrine cancers announced today that Tozaride, the Company’s targeted peptide therapy, has been granted Orphan Drug Designation by the U.S. Food & Drug Administration (FDA) for the treatment of small cell lung cancer (SCLC).
Orphan drug designation is granted by the FDA Office of Orphan Products Development (OOPD) to novel drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S. The designation provides the drug developer with a seven-year period of U.S. marketing exclusivity, as well as tax credits for clinical research costs, the ability to apply for annual grant funding, clinical research trial design assistance and waiver of Prescription Drug User Fee Act (PDUFA) filing fees. The OOPD also works on rare disease issues with the medical and research communities, professional organizations, academia, industry, and rare disease patient groups.
“Tozaride is designed to treat SCLC patients identified by its companion diagnostic as most likely to benefit from this targeted therapy. This novel approach holds great promise for this patient population where therapeutic options are very limited and personalized approaches are needed” stated Chris Adams, Chief Executive Officer of Andarix. “We intend to push forward with development of the Tozaride program in SCLC in order to bring more therapeutic options to this rare disease.”
Tozaride, Re188-P2045, is a novel, best-in-class therapy for lung and other cancers based on a radio-labeled somatostatin peptide analogue. Early clinical studies of Tozaride demonstrated that it is well tolerated and may produce prolonged stable disease and improved overall survival in advanced lung cancer patients whose disease has continued to progress after failing other therapies. Targeted radiotherapy with Tozaride in patients identified with its companion diagnostic represents a new treatment paradigm which is expected to yield significant clinical benefit for both small cell lung cancer (SCLC), and non-small cell lung cancer (NSCLC) patients, and which will provide another treatment option for patients who are not eligible for, or who have not responded to current therapies.
About Small Cell Lung Cancer
Small cell lung cancer SCLC accounts for 15-20% of lung cancers or approximately 30,000 patients in the US and 40,000 in Europe. Unlike the more common non-small cell lung cancers (NSCLC), small cell lung cancer grows rapidly, and therefore can often, initially respond well to chemotherapy. However, it becomes more resistant to treatment as the disease progresses and has an overall survival rate of only 6%. Development of
novel therapies for SCLC is crucial as there have been no new approved agents for >3rd line or refractory patients in over 20 years.
About Andarix Pharmaceuticals
Andarix Pharmaceuticals is at the forefront of personalized therapies for cancer, developing both the imaging agents that can identify appropriate patients, as well as the targeted therapies for these patients. The company’s products have progressed through early clinical development. The Andarix technology is based on a proprietary somatostatin peptide conjugate applicable to lung, neuroendocrine, and other cancers. Extensive research has demonstrated that somatostatin receptors are highly up-regulated on several solid tumors, particularly lung cancers. To learn more about Andarix, please visit www.andarix.com.