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Agennix's Oral Talactoferrin Improved Response Rates, Time to Progression and Duration of Response When Combined With First-Line Chemotherapy in Advanced Non-Small Cell Lung Cancer

[This is a private company, so don’t try to find the ticker symbol!]

http://biz.yahoo.com/prnews/050517/nytu078.html?.v=8

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Results from a Double-Blind, Randomized, Placebo-Controlled Phase II Trial Presented at ASCO

HOUSTON, May 17 /PRNewswire/ -- Agennix Incorporated announced results from a double-blind, randomized, placebo-controlled, multi-center Phase II clinical trial evaluating oral talactoferrin alfa (talactoferrin). 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). Data on the primary endpoint (best overall response by CT scan using RECIST criteria) was presented at the American Association for Cancer Research (AACR) annual meeting last month. The trial met its primary endpoint of detecting an improvement in response rate (p=0.05). Results from tumor related secondary endpoints were presented today at the 2005 Annual Meeting of the American Society of Clinical Oncology (ASCO) in Orlando.

The addition of oral talactoferrin to carboplatin/paclitaxel (C/P) enhanced the patients' response to chemotherapy on all the tumor related endpoints including response rate, progression free survival (PFS), time to response, and duration of response. Talactoferrin appeared to be safe and well tolerated with no drug-related significant adverse events.

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. The median PFS increase in the ITT and evaluable patients was 0.6 months (14% improvement) and 2.5 months (61% improvement), respectively. The PFS rate at 18-weeks (end of treatment period) increased by 13% (a 30% relative improvement) and 16% (a 36% relative improvement) in the ITT and evaluable patients, respectively. The median time to first response decreased by 1.3 months (a 50% improvement). The median duration of response has not yet been reached, but currently shows a 1.3 month (30%) increase relative to placebo.

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 data suggests that adding talactoferrin, an immune stimulating agent, to standard chemotherapy substantially improves clinical results in non-small cell lung cancer. It is especially encouraging that patients are also showing an improvement in all of the tumor related secondary endpoints. I look forward to seeing results in a Phase III trial with a larger number of patients that can help to confirm talactoferrin's importance in this patient population."

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 (C: AUC 5 mg/mL/min; P: 175 mg/m(2)). 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 were included in the ITT population. The 100 patients who had at least one CT scan after starting treatment were included in the prospectively defined evaluable population.

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 anti-cancer activity of standard chemotherapy. Talactoferrin has been administered to over 500 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. 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 protein and peptide drug candidates 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.
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