ILEX Oncology Announces Phase III Trial for Skin Cancer Prevention
ILEX Oncology Inc. has announced a Phase III trial to evaluate the efficacy of its anticancer agent alpha-difluoromethylornithine (DFMO) in preventing non-melanoma skin cancer. The trial, led by Dr. Paul P. Carbone, will test DFMO against a placebo in a double-blind, controlled, randomized study of 340 patients with a history of basal cell or squamous cell cancer. The study aims to determine whether DFMO can inhibit the recurrence of cancer and potentially treat the underlying cause rather than the effect.
Key Takeaways:
- The Phase III trial will enroll 340 patients with a history of basal cell or squamous cell cancer to test the efficacy of DFMO in preventing non-melanoma skin cancer.
- The trial will be a double-blind, controlled, randomized study, with patients receiving either DFMO or a placebo in low doses for an average of four years.
- DFMO has shown promising results in previous studies as a preventative agent for various cancers in animals.
- The trial is sponsored by the National Cancer Institute (NCI) and will assess DFMO's ability to interfere with the underlying process of cancer development and progression.
- Over 900,000 new cases of basal cell or squamous cell cancers are diagnosed each year in the United States, with individuals with a history of these cancers having a 50% chance of developing new skin cancers within five years.
- ILEX Oncology is also conducting Phase II trials to assess DFMO's efficacy as a chemoprevention agent in recurrent colon polyps, Barrett's esophagus, and other precancerous conditions.
- ILEX Oncology Inc. is a drug development company focused exclusively on the development and marketing approval of drugs for the treatment and prevention of cancer.
Statistics:
- Over 900,000 new cases of basal cell or squamous cell cancers are diagnosed each year in the United States.
- Individuals with a history of basal or squamous cell cancer have a 50% chance of developing new skin cancers within five years.
- The trial will test DFMO against a placebo in a double-blind, controlled, randomized study of 340 patients.
- The study aims to assess DFMO's efficacy in preventing non-melanoma skin cancer over a period of four years.
Sources:
- ILEX Oncology Inc.
- National Cancer Institute (NCI)