Agennix’s Oral Talactoferrin Substantially Improved Response Rates when Combined with First-Line Chemotherapy in Advanced Non-Small Cell Lung Cancer
Results from a Double-Blind, Randomized, Placebo-Controlled Phase II Trial Combining Talactoferrin Alfa or Placebo with a Standard Regimen of Carboplatin/Paclitaxel will be Presented at AACR
HOUSTON -April 19, 2005- Agennix Incorporated announced results from a double-blind, randomized, placebo-controlled, multi-center Phase II clinical trial evaluating oral talactoferrin alfa (talactoferrin), the Company’s proprietary recombinant human lactoferrin. Talactoferrin was combined with standard chemotherapy and compared to placebo plus standard chemotherapy in first-line treatment of advanced non-small cell lung cancer (NSCLC). The data will be presented today in a late breaking poster session at the 96th Annual Meeting of the American Association for Cancer Research (AACR) in Anaheim.
The addition of oral talactoferrin to carboplatin/paclitaxel (C/P) substantially enhanced the best overall response by CT scan using RECIST criteria, which was the trial’s primary endpoint. The confirmed response rate in all 110 randomized intent-to-treat (ITT) patients increased from 27% with placebo to 42% with talactoferrin, a 15% absolute increase and a 56% relative increase. The confirmed response rate in the 100 prospectively defined evaluable patients increased from 29% to 47% (p=0.05), an 18% absolute improvement and a 62% relative improvement. Talactoferrin also appeared to be safe and well tolerated.
"We are excited about our talactoferrin program in cancer," commented Agennix CEO Rick Barsky. "Such a substantial improvement in response rate without increased toxicity supports expeditious further development of talactoferrin in this indication."
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 commented: "This level of improvement in confirmed response rate in a double-blind, placebo-controlled trial in front-line NSCLC is clearly clinically significant. If repeated in a Phase III trial, then I believe talactoferrin will be a very important cancer drug."
About the Study
The goal of this randomized, double-blind, placebo-controlled Phase II study was to determine if talactoferrin improves the effectiveness of a standard first-line chemotherapy regimen (carboplatin/paclitaxel; C/P) in patients with advanced NSCLC. One hundred and ten (110) chemo-naive patients with advanced or metastatic NSCLC were enrolled at eleven cancer centers. The patients were randomized (1:1) to receive standard therapy (C/P) plus either talactoferrin or placebo. C/P was administered in 3-week cycles. Talactoferrin (or placebo) was administered orally, 1500 mg B.I.D., in 35-day cycles for up to three cycles or until radiological progression, starting the day following C/P dosing in chemo-cycles 1, 3 and 5. The primary endpoint was best overall response by CT scan using RECIST criteria. All 110 patients were evaluable for safety, and the 100 patients who had at least one CT scan after starting treatment were evaluable for response rate.
About Talactoferrin Alfa
Talactoferrin alfa is a novel immunostimulatory agent with demonstrated anti-cancer activity in animals and NSCLC patients in Phase I/II trials. In animal experiments, oral talactoferrin induced the proliferation of NK-T and CD-8+ cells and potentiated the anticancer activity of standard chemotherapy. Oral talactoferrin has been administered to over 400 people and appears safe and well tolerated.
About Non-Small Cell Lung Cancer
Lung cancer is responsible for nearly 30 percent of cancer deaths in the United States, according to the National Cancer Institute. More than 173,000 people in the United States will be diagnosed with lung cancer this year, and according to the World Health Organization there are more than 1.2 million cases of lung and bronchial cancer diagnosed each year worldwide, causing approximately 1.1 million deaths annually. Almost 80 percent of lung cancer is non-small cell (NSCLC). Current treatments for lung cancer include surgery, chemotherapy, radiation, and targeted molecular therapy, in spite of which there are over 160,000 deaths per year in the United States alone.
About Agennix
Agennix, a privately owned Houston-based biopharmaceutical company, is developing patented proteins and peptides including talactoferrin alfa (talactoferrin), an immunostimulatory protein. Talactoferrin appears to be safe and well tolerated after administration to over 500 people, and appears to be effective in treating cancer and diabetic foot ulcers. Agennix holds 76 patents on this molecule, including broad composition of matter coverage. The Company has seven Phase II human clinical trials currently underway in the treatment of cancer and diabetic foot ulcers, with company sponsored U.S. INDs in both areas.
More information about Agennix is available on the Company's web site at http://www.agennix.com.