VAMC and Agennix Successfully Complete Safety Phase of Lactoferrin Cancer Trial
HOUSTON, May 22, 2003 - The Department of Hematology/Oncology at the Veterans Affairs Medical Center, Houston (VAMC) and Agennix Inc., announced the completion of the safety portions of two Phase 1/2 cancer trials with oral recombinant human Lactoferrin (rhLF). The trials are taking place in the United States and in South America. Teresa G. Hayes, M.D., Ph.D., the Principal Investigator at the VAMC, is conducting the U.S. trial. The South American trial is being conducted at six centers in Argentina, Brazil and Chile.
Lactoferrin, a protein found naturally in milk and other exocrine secretions, plays an essential role in stimulating the body's immune system. The clinical trials are evaluating rhLF as a single agent for the treatment of solid tumor cancer patients, who had progressed on standard chemotherapy and whose tumors were not resectable. The trial design was based on results from over twenty-five different animal experiments showing that lactoferrin significantly inhibits tumor growth and metastases in a variety of solid tumors.
Thirty patients were enrolled in the safety phase of the trials, and administered one of four different doses of rhLF, ranging from 1.5 g/day to 9 g/day, for either 14 days (South America) or in cycles of 14 days with a 14 day gap (VAMC). Patients were observed for adverse events, and tumor size was measured radiologically at baseline and 8 weeks following start of therapy. Of the 30 patients enrolled, 29 completed dosing, with one patient withdrawing prior to completion due to progressive disease. The drug, which is administered orally, was well tolerated without a single drug related serious adverse event or a drug-related laboratory abnormality greater than Grade 2. Safety results are presented in an abstract submitted to the upcoming annual meeting of the American Society of Clinical Oncology.
To date, nineteen patients are evaluable for tumor response (those with a baseline and an 8-week post rhLF treatment CT scan). Of these, 53% (10 of 19 patients) had stable disease by RECIST criteria, three of whom showed some tumor shrinkage. Patients with tumor shrinkage had ovarian cancer, metastatic melanoma or gastric cancer.
In the ongoing efficacy phase of the trials, an additional 38 patients will be treated with the highest rhLF doses. Complete results are expected later in the year.
About VAMC:The Houston Veterans Administration Medical Center is the largest facility in the nationwide VA system. Patients from a large catchment area, including Texas, Louisiana and Mississippi, come to the Houston VA for cancer treatment. The modern facility, certified as a Cancer Center by the American College of Surgeons, is staffed with Board-Certified Hematologists and Oncologists. All modalities of cancer care are available at the VAMC, including chemotherapy, radiation therapy, and surgery.
About Agennix:
Agennix, a Houston-based biopharmaceutical company, is the world leader in the development of recombinant human lactoferrin (rhLF), a natural immuno-stimulatory and anti-inflammatory protein, and a variety of patented peptides. RhLF has been administered to over 300 people without a single drug-related serious adverse event, and has demonstrated pre-clinical efficacy in treating cancer and asthma, and accelerating wound healing. Phase II clinical trials are underway in all three areas. Agennix is the first and only company to manufacture commercial quantities of human lactoferrin and holds global patents on its technology, with 71 issued patents and more than 30 patents pending. More information about Agennix is available on the Company's web site at: www.agennix.com.