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Agennix Receives Special Protocol Assessment Approval from FDA for the Pivotal Trial of Talactoferrin Alfa in First-Line Non-Small Cell Lung Cancer

Trial will also Support a Marketing Authorization Application in the

European Union

HOUSTON, Jan. 17 /PRNewswire/ -- Agennix Incorporated announced today that the U.S. Food and Drug Administration (FDA) has approved the design of a single, pivotal, Phase 3 trial evaluating its lead molecule, talactoferrin alfa, in combination with chemotherapy as first-line treatment in patients with non-small cell lung cancer (NSCLC) under the Special Protocol Assessment (SPA) process. Separately, Agennix received Scientific Advice from the European Medicines Agency (EMEA) indicating that this single trial will also support a Marketing Authorization Application (MAA) in the European Union. Agennix had previously received Fast Track designation from the FDA for this indication.

"The Special Protocol Assessment agreement with the FDA is an important step for advancing the investigation of talactoferrin in NSCLC," said Dr. Roman Perez-Soler, Director, Division of Medical Oncology, Albert Einstein College of Medicine, New York City. "The Phase 2 data from the two separate randomized, double-blind, placebo-controlled NSCLC trials are very promising. I look forward to participating in the Phase 3 talactoferrin trials for both NSCLC indications -- first-line in combination with chemotherapy, and talactoferrin monotherapy in patients who have failed two or more previous therapies."

In the randomized, double-blind, placebo-controlled Phase 2 NSCLC trials, talactoferrin (or placebo) was administered either in combination with chemotherapy in chemo-naive patients, or as monotherapy in patients who had failed previous chemotherapy. Both trials met their prospectively defined primary endpoints -- improvement in response rate (first-line combination trial) and improvement in survival (monotherapy trial), with supporting trends on secondary efficacy endpoints. Both trials also showed statistically significant reductions in total adverse events and in significant (grade 3 or higher) adverse events in the talactoferrin arms.

Agennix is preparing to initiate Phase 3 trials in both NSCLC indications (talactoferrin in combination with chemotherapy in previously untreated patients and talactoferrin monotherapy in patients who have failed two or more previous therapies).

"Talactoferrin has the potential to be an important advance in the treatment of NSCLC," 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. "The activity and safety profile seen in the talactoferrin trials to date are very exciting and provide hope for improved treatment of this disease. I look forward to confirmation of the Phase 2 results in the Phase 3 trials."

About the Phase 3, First-Line NSCLC Study

The Phase 3, multinational, randomized, double-blind, placebo-controlled study will enroll 1,100 previously untreated patients with Stage IIIB or IV NSCLC. The patients will be randomly assigned to receive up to six cycles of standard chemotherapy (carboplatin + paclitaxel) plus either oral talactoferrin or placebo. Following six cycles of chemotherapy, or discontinuation prior to six cycles for reasons other than progression, patients will receive talactoferrin or placebo as maintenance therapy until disease progression. Progression-free survival and overall survival will be the primary endpoints for accelerated approval and regular approval, respectively. Secondary endpoints include adverse event reductions, confirmed response rate, duration of response and safety.

About the SPA

The SPA approval represents a binding agreement (in the absence of new public health concerns unrecognized at the time of protocol assessment) between the Company and the FDA that the design and planned analyses of the study will adequately support a biologics license application (BLA). As part of the SPA process, the FDA reviewed and approved the trial protocol, statistical analysis plan, independent radiological review charter, data safety monitoring board charter, case report forms and site reference manual. Before approving the SPA, the FDA also evaluated product characterization data for batch-to-batch consistency for Phase 3 and commercial talactoferrin production.

About Talactoferrin Alfa

Talactoferrin, a novel dendritic cell activator (DCA), is a unique recombinant form of human lactoferrin, an important immunomodulatory protein.

In 1988, Dr. Bert O'Malley, chair of molecular and cellular biology at Baylor College of Medicine, Houston, Texas, discovered a way to produce this protein in the laboratory, thus paving the way for testing its potential to help fight serious diseases that cause enormous suffering worldwide. "Baylor views this as exciting news, not only for the important research being done at this medical school but also for the historic battle being conducted to find effective treatments for the most lethal forms of cancer," said Dr. Peter Traber, President of Baylor College of Medicine. "It is our sincere hope that the Phase 3 trials will be successful and this drug can be eventually used globally."

Lactoferrin, found in the highest concentration in milk, is expressed throughout the body in immune cells and on all body surfaces exposed to the external environment. Lactoferrin plays an important role in helping to establish the immune system, including the Gut Associated Lymphoid Tissue (GALT), in infants. Talactoferrin is produced in Aspergillus niger, a filamentous fungus, and is structurally identical to native human lactoferrin in all material respects, differing only in its glycosylation.

Talactoferrin is an orally administered protein that mediates its activity through the gut and the GALT -- the largest lymphoid organ in the body. It acts through a novel mechanism of dendritic cell recruitment and activation. Following oral administration, talactoferrin is transported by the M-cells into the small intestinal Peyer's Patches, where it recruits circulating immature dendritic cells bearing tumor antigens to the GALT and induces their maturation. DC maturation in the presence of tumor antigens and lymphoid effector cells induces a strong systemic innate and adaptive immune response mediated by anti-cancer Natural Killer (NK) cells, CD8+ lymphocytes and NK-T cells. This results in the activation of tumor-draining lymph nodes, cellular infiltration of distant tumors and tumor-cell death. Mounting the initial immune response in the GALT -- away from the primary tumor and using a physiologically important pathway -- minimizes the effect of the cancer's local immunosuppressive defenses.


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 diagnosed with NSCLC have late- stage disease (Stage IIIB or IV), which is not surgically resectable. The current U.S. standard of care for these patients is systemic chemotherapy. Even with the available therapy, the five-year survival rate for these patients is less than 3%.

About Agennix

Agennix is a private biotechnology company developing a first-in-class molecule with activity in several types of cancer and in other indications with unmet medical needs. This molecule, talactoferrin, is a targeted dendritic cell activator with a novel mechanism of action. Agennix is preparing to initiate Phase 3 trials in two NSCLC indications (talactoferrin in combination with chemotherapy in previously untreated patients and talactoferrin monotherapy in patients who have failed two or more previous therapies), a Phase 2b trial in renal cell cancer, and Phase 2 trials in other indications. Talactoferrin's potential advantages in NSCLC and in other tumor types include its promising anti-tumor activity, its well tolerated safety profile including a reduction of some chemotherapy toxicities, its oral route of administration, and its apparent usefulness in multiple tumor types both as a single agent and in combination with other drugs. Agennix retains all of the commercial and economic rights to talactoferrin for all indications worldwide, and has strong global intellectual property protection for talactoferrin.

More information about Agennix is available on the Company's web site at

SOURCE Agennix Incorporated
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