Healthcare Industry News: NSCLC
News Release - June 4, 2007
Survival Benefit Demonstrated in Placebo-Controlled Trial in Patients with Refractory Non-Small Cell Lung Cancer Treated with Agennix's Oral TalactoferrinData from the Randomized, Double-Blind, Placebo-Controlled Phase II Trial Presented at ASCO
HOUSTON, June 4 (HSMN NewsFeed) -- Agennix Incorporated today announced results from a fourth positive Phase II trial with its lead molecule talactoferrin alfa, an immunomodulatory protein with a novel mechanism of action. This trial, which compared oral talactoferrin monotherapy to placebo in patients with refractory non-small cell lung cancer (NSCLC), met its primary endpoint of a statistically significant improvement in overall survival. Secondary efficacy endpoints also showed improvement consistent with the primary endpoint results. Oral talactoferrin was well tolerated in this patient population with fewer adverse events observed in the talactoferrin arm. These data were presented Saturday, June 2, at the 2007 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.
Oral talactoferrin significantly improved overall survival in this study. In the 100-patient intent-to-treat (ITT) population, median overall survival was 62% higher in the talactoferrin group than in the placebo group - 6.0 months versus 3.7 months, respectively (hazard ratio=0.69; p=0.0476). In the 81-patient prospectively-defined evaluable population, the median overall survival was 73% higher in the talactoferrin group than in the placebo group - 7.6 months versus 4.4 months, respectively (hazard ratio=0.60; p=0.0213). The six-month survival rate in the ITT population was also significantly better in the talactoferrin group (49%) than the placebo group (28%), p=0.0276. In addition, overall survival improvement trends were consistent across subsets of patients grouped by prognostic factors, including disease stage, performance status, and line of therapy.
In addition to improving overall survival, oral talactoferrin was well tolerated by refractory NSCLC patients. Adverse events (AEs) were generally mild, and no drug-related serious AEs were reported. In addition, there were 28% fewer AEs and 51% fewer Grade 3/4/5 AEs in the talactoferrin group relative to the placebo group (p=0.0015 and p=0.0005, respectively).
This was the second successful placebo-controlled trial with oral talactoferrin in NSCLC. The first was in combination with first-line chemotherapy. Preparations for Phase III trials with talactoferrin are underway in both NSCLC indications: (i) first-line in combination with chemotherapy, and (ii) single-agent treatment of patients with refractory disease.
About the Study
In this Phase II single-agent study, 100 patients with stage IIIB/IV NSCLC, whose cancer had progressed after first- or second-line chemotherapy, were enrolled at 10 leading oncology centers in India and randomized to receive standard supportive care plus either placebo (n=53) or talactoferrin 1.5 g orally twice a day (n=47). Patients did not receive any other anti- cancer therapy while on the trial. Treatment was administered in 14-week cycles (12 weeks on, two weeks off) for up to three cycles or until disease progression. The primary endpoint was overall survival. All 100 patients were included in the ITT population. The 81 patients who had at least one CT scan after initiating treatment were prospectively defined as the evaluable population.
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 talactoferrin binds to keratinocytes and fibroblasts and increases the local production of cytokines and chemokines critical to wound healing.
Both oral and topical formulations of talactoferrin appear to be well tolerated. Over 600 patients have been dosed with talactoferrin, including patients who had exposure to talactoferrin lasting over two years, without any drug-related serious AEs.
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%.
Agennix is a private biotechnology company developing a first-in-class molecule for the treatment of cancer and for wound healing. This molecule, talactoferrin, is an immunomodulatory recombinant 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 95 issued patents and 47 pending patents broadly protecting talactoferrin composition of matter, use, and manufacturing methods.
More information about Agennix is available on the Company's web site at http://www.agennix.com.
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