HOUSTON, Oct. 5 /PRNewswire/ -- Agennix today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the Company’s Talactoferrin Alfa (talactoferrin or TLF) clinical development programs for first-line non-small cell lung cancer (NSCLC) and diabetic foot ulcers. Fast Track is a process designed to facilitate the development and expedite the review of drugs that treat serious diseases and address unmet medical needs.
Agennix submitted applications to the FDA for Fast Track designation based on positive randomized, placebo-controlled Phase II results with oral TLF solution in NSCLC and with topical TLF gel in diabetic foot ulcers.
“We are pleased that the FDA has recognized our lead product, Talactoferrin Alfa, as a potential therapy for patients with these two serious conditions that currently have limited treatment options,” said Dr. Frank Young, Chairman of Agennix, and former Commissioner of the FDA. “This Fast Track designation is an important classification as we advance this product into late-stage development.”
NSCLC
Oral talactoferrin was recently evaluated in first-line NSCLC in a 110-patient, randomized, double-blind, placebo-controlled, multi-center Phase II clinical trial. Results were presented at the American Society of Clinical Oncology (ASCO) 2006 Annual Meeting. Patients with advanced NSCLC (stage IIIb or IV) received standard first-line chemotherapy, carboplatin/paclitaxel, plus either oral TLF or placebo. The trial met its primary endpoint (best overall confirmed response by CT scan using RECIST criteria), with a substantial improvement in response rate. Substantial improvements in the TLF arm were also observed for secondary endpoints, including progression-free survival (PFS) and overall survival. TLF appeared to be safe and extremely well tolerated without a single drug-related Serious Adverse Event. TLF-treated patients had fewer total Adverse Events (AEs) and fewer significant (Grade 3/4) AEs than patients receiving chemotherapy alone. The efficacy and safety results generated by TLF in this trial compare favorably to randomized results generated by other drugs in first-line NSCLC.
“Based on the Phase II data, I believe that this drug can provide tremendous benefit to patients,” said Dr. Waun Ki Hong, head of the Division of Cancer Medicine at M.D. Anderson Cancer Center and member of Agennix’s Scientific Advisory Board. “Assuming similar results in Phase III, this should be made broadly available to patients as quickly as possible.”
The Company will seek a Special Protocol Assessment from the FDA for a large pivotal Phase III trial in NSCLC, and expects to initiate this trial in the first half of 2007.
Diabetic Foot Ulcers
Agennix also completed a randomized, placebo-controlled, NIH-sponsored, Phase II clinical trial evaluating topical TLF in patients with diabetic foot ulcers. The results were presented at the 2006 Symposium on Advanced Wound Care and Medical Research Forum on Wound Repair, and have been accepted for publication in the American Journal of Surgery. The trial met its prospectively defined primary endpoint of improvement in the incidence of 75 percent or greater healing at the end of 12-week dosing relative to placebo. Talactoferrin gel enhanced wound healing compared to a placebo gel with a relative improvement that was superior to published results with the currently approved therapy.
“The clinical data with talactoferrin is very promising,” commented Dr. Aristidis Veves, Research Director of the Joslin-Beth Israel Deaconess Foot Center, Associate Professor of Surgery at Harvard Medical School, and a principal investigator in the Phase II trial. “There is a tremendous and growing need for new drug therapies for diabetic foot ulcers, and talactoferrin appears to have the potential to be broadly used.”
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 NSCLC
In the United States, lung cancer is the second most frequent cancer in both men (next to prostate cancer) and women (next to breast cancer). It remains the major cause of cancer death, killing more people than breast cancer, prostate cancer and colorectal cancer combined, and accounting for almost 30% of all cancer-related deaths.
NSCLC accounts for approximately 80% of all new lung cancer cases, with approximately 150,000 patients in the United States and 300,000 patients in Europe diagnosed each year. Most patients with NSCLC have late-stage disease (Stage IIIb or IV), which is not surgically resectable, when they are diagnosed. The current U.S. standard of care for these patients is the combination of two off-patent chemotherapeutic agents: paclitaxel and carboplatin. Even with this first-line chemotherapy, and some available second and third-line drugs, the five-year survival for these patients is less than 3%.
About Diabetic Foot Ulcers
There are at least 17 million people with diabetes in the United States, and approximately 1 million new cases are diagnosed each year. Fifteen percent of all people with diabetes (2.6 million) are expected to develop foot ulcers during their lifetimes, which tend to be chronic in nature -- they do not heal or do so extremely slowly. Currently, there are approximately 750,000 patients with diabetic foot ulcers in the United States, 980,000 in Europe and 1.1 million in the rest of the world -- a total of 2.8 million patients. Diabetic foot ulcers are serious -- up to 25% of diabetic foot ulcers will eventually require an amputation.
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.
More information about Agennix is available on the Company’s web site at http://www.agennix.com.
Source: Agennix
