HOUSTON, May 19 /PRNewswire/ -- Agennix announced today that talactoferrin alfa (talactoferrin) has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the first-line treatment of renal cell carcinoma (RCC) in combination with sunitinib (Sutent(R) - Pfizer).
The Fast Track program is designed to expedite the review of investigational drugs for the treatment of patients with serious or life-threatening diseases where there is an unmet medical need. Fast Track designations allow a company to file a New Drug Application (NDA) or Biologics License Application (BLA) on a rolling basis and permit the FDA to review the filing as it is received, rather than waiting for the complete submission prior to commencing the review process. Additionally, NDAs and BLAs for fast track development programs are eligible for priority review which may result in an abbreviated review time of six months.
Additional Clinical Updates
Agennix also announced that two pivotal Phase III trials in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) are underway at a number of leading U.S. clinical sites. FORTIS-M is a randomized, placebo-controlled, 720-patient trial of talactoferrin monotherapy in patients with Stage IIIB/IV NSCLC. Patients who have failed two or more prior systemic anti-cancer therapies will be randomly assigned (2:1) to receive either oral talactoferrin or placebo in additional to standard supportive care. The trial is designed to detect an improvement in overall survival in patients receiving talactoferrin, and results are expected in 2011.
FORTIS-C is a randomized, placebo-controlled trial evaluating 1100 chemo-naive NSCLC patients. Newly diagnosed patients with Stage IIIB/IV NSCLC will be randomly assigned (1:1) to receive standard first-line chemotherapy with carboplatin and paclitaxel plus either oral talactoferrin or placebo. Agennix has received Fast Track designation from the FDA for both NSCLC indications as well as favorable Scientific Advice from the EMEA. Agennix has also received approval of a Special Protocol Assessment from the FDA for the FORTIS-C trial. The designs of these two Phase III trials are based on previous successful randomized, placebo-controlled, Phase II trials which both met their primary endpoint with supporting results on the secondary endpoints.
"We are pleased with the continued development progress with talactoferrin including our most recent Fast Track designation and the initiation of our Phase III NSCLC trials," said Rick Barsky, Chief Executive Officer, Agennix Incorporated. "This progress, along with the recent success and renewed interest in immunotherapies, will help us reach our goal of making talactoferrin available to patients for the treatment of these devastating diseases."
Talactoferrin is a novel targeted dendritic cell recruiter and activator (DCRA) being studied for the treatment of several life-threatening diseases including RCC and NSCLC. Talactoferrin mediates its anti-cancer activity by targeting dendritic cells which play an important role in activating innate and adaptive immunity. After being transported into the gut associated lymphoid tissue (GALT), the largest immune organ in the body, orally administered talactoferrin induces the recruitment of immature dendritic cells to the GALT and promotes their maturation. This unique aspect of its function results in recruitment of dendritic cells that have captured tumor antigens while in the peripheral circulation. Following maturation, these dendritic cells activate Natural Killer (NK) and Natural Killer T-cells (NK-T) of the innate immune pathway and CD8+ lymphocytes of the adaptive immune pathway. Initiating the immune response in the GALT, and away from the tumor, reduces the effect of anti-immune factors produced by the tumor.
Talactoferrin Fast Track Designations
Agennix has received Fast Track designation for talactoferrin for the first-line treatment of RCC in combination with sunitinib. Agennix's RCC submission included the results from a Phase I trial, and a multi-center, single arm Phase II trial of talactoferrin in 44 patients with clear cell RCC who had failed standard therapy. Patients receiving oral talactoferrin in this Phase II trial had a median progression-free survival of 6.4 months, median overall survival of 21.1 months, and a one-year survival rate of 77%. Talactoferrin appeared to be well tolerated, which was consistent with other talactoferrin studies. The results from the Phase II trial were published in Cancer in 2008.
Talactoferrin was previously awarded Fast Track designations in NSCLC both for first line treatment and for patients who have failed two or more prior systemic anti-cancer therapies. These NSCLC Fast Track designations were based upon the clinical activity and tolerability data from two randomized placebo-controlled Phase II trials. Both Phase II trials met their primary endpoint with supporting results on the secondary endpoints.
About Renal Cell Carcinoma (RCC)
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 49,000 new cases of kidney cancer diagnosed each year in the United States. Kidney cancer is 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. Currently, sunitinib is the most prescribed targeted therapy for first-line treatment of RCC.
Agennix is a private biopharmaceutical company developing a first-in-class molecule with immunological activity for the treatment of cancer and other unmet medical needs. Agennix'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. Agennix has recently initiated Phase III trials in two non-small cell lung cancer indications (talactoferrin monotherapy in patients who have failed two or more previous therapies, and talactoferrin in combination with chemotherapy in previously untreated patients), and is planning a Phase IIb trial in patients with renal cell cancer, and Phase II trials in other cancer indications.
The company has recently agreed to merge its business with GPC Biotech, a publicly traded biopharmaceutical company focused on developing anti-cancer drugs. The merger is subject to the approval of the shareholders' meeting of GPC Biotech and to further closing conditions, and is expected to be completed by the end of 2009.
Forward Looking Statements
This press release contains forward-looking statements, which express the current beliefs and expectations of the management of Agennix. Such statements are based on current expectations and are subject to risks and uncertainties, many of which are beyond our control, that could cause future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Actual results could differ materially depending on a number of factors, and we caution investors not to place undue reliance on the forward-looking statements contained in this press release. There can be no guarantee that the merger with GPC Biotech will be completed. Forward-looking statements speak only as of the date on which they are made and Agennix undertakes no obligation to update these foward-looking statements even if new information becomes available in the future.
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