ANDARIX Pharmaceuticals, a leader in the discovery and development of targeted peptide therapy for lung and neuroendocrine cancer announced today that P2045, the Company’s lead candidate for 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, governmental agencies, industry, and rare disease patient groups.
“P2045 is designed to identify and then treat those patients who may benefit the most from this targeted therapy in the SCLC patient population where therapeutic options are very limited” stated Chris Adams, Chief Executive Officer of Andarix. “We greatly value this designation and the support of the OOPD, and welcome other development partners in this important effort. We intend to actively move forward with development of the P2045 program in SLCL in order to bring more therapeutic options to this rare disease community.”
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 P2045 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. P2045 targeted radiotherapy represents a new treatment paradigm which is expected to yield significant clinical benefit for both small cell lung cancer (SCLC), and non-small cell (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% of lung cancers or approximately 25,000 patients in the US and 40,000 in Europe with a prevalence of 1:20,000. 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. The overall survival rate for small cell lung cancer is only about 6%.
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. Lung cancer is the leading cause of cancer mortality in the United States, with over 170,000 new diagnoses of non-small cell lung cancer (NSCLC) and over 150,000 deaths attributable to this disease annually. To learn more about Andarix, please visit http://www.andarix.com.
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