Agennix today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the Company’s oral formulation of Talactoferrin Alfa (talactoferrin or TLF) for the treatment of renal cell carcinoma (RCC). Oral TLF is currently in Phase II clinical development for RCC. Results from a multi-center Phase 2 RCC trial that included six leading U.S. cancer centers were presented at the 2006 Annual meeting of the American Society of Clinical Oncology (ASCO).
“The Phase 2 results with talactoferrin in RCC are promising,” said Dr. Eric Jonasch, an Oncologist in Genitourinary Medical Oncology at the M.D. Anderson Cancer Center, and a principal investigator in the trial. “I look forward to participating in future studies that may lead to the availability of TLF for RCC patients.”
“Metastatic RCC is a devastating disease with limited treatment options,” said Dr. Teresa G. Hayes, a Medical Oncologist at the Baylor College of Medicine and the Michael DeBakey VA Medical Center, and an investigator in several talactoferrin trials. “Several of my patients have done extremely well for a very long time on treatment with oral single-agent talactoferrin. The medication is easy to take and has few side effects. I hope it will be available to prescribe to patients very soon.”
Agennix also recently received FDA Fast Track designation for the Company’s clinical development programs for oral TLF solution in first-line non-small cell lung cancer and topical TLF gel in diabetic foot ulcers.
About Orphan Drug Designation
The U.S. Orphan Drug Act provides incentives for companies developing and marketing therapies for rare diseases, defined as those affecting fewer than 200,000 Americans. The Act grants orphan drug companies with market exclusivity for a particular indication for a period of seven years following FDA approval. Orphan drug designation also facilitates the drug development process by providing companies with protocol assistance, clinical trial support, tax credits, grant funding for research, and waiver of the Prescription Drug User Fee Act (PDUFA) filing fee.
About Talactoferrin Alfa
Talactoferrin Alfa is a unique recombinant form of human lactoferrin, an immunomodulatory protein. Talactoferrin acts by binding to specific receptors found on target cells and inducing the production of key immunomodulatory cytokines and chemokines. Orally administered talactoferrin binds to enterocytes lining the upper gastrointestinal tract, initiating an immunostimulatory cascade in the gut associated lymphoid tissue. This results in the activation of both innate and adaptive immunity including recruitment and activation of dendritic cells, NK-T cells and CD8+ lymphocytes. This is followed by systemic immunostimulation, the activation of tumor-draining lymph nodes, and infiltration of distant tumors by immune cells, which results in killing of the cancer cells. Topically administered TLF binds to keratinocytes and fibroblasts and increases the local production of cytokines and chemokines critical to wound healing.
About Renal Cell Carcinoma
Renal cell carcinoma (RCC) is the most common type of kidney cancer, accounting for approximately 90 percent of kidney tumors. According to the American Cancer Society, there are approximately 39,000 new cases of kidney cancer diagnosed each year in the United States. Kidney cancer is very uncommon under age 45, and its incidence is highest between the ages of 55 and 84. For non-metastatic RCC, the current standard of care is surgical removal of the kidney (nephrectomy), followed by observation. If the cancer spreads beyond the kidneys, treatment may include chemotherapy, cytokine therapy, targeted therapy, and/or radiation.
About Agennix
Agennix is a private biotechnology company developing a first-in-class molecule with potent immunological activity for the treatment of cancer and wound healing. The Company’s lead molecule, talactoferrin, is an immunomodulatory protein with a novel mechanism of action. The Company is developing an oral liquid formulation of talactoferrin for cancer indications and a topical gel formulation for the treatment of diabetic foot ulcers. Agennix has more than 90 issued patents and more than 50 pending patents broadly protecting talactoferrin.