Ribi ImmunoChem Research Inc. today announced that it will begin testing its anti-tumor product Detox(TM) for treatment of venereal and genital warts (condyloma acuminata).
Company President Nils A. Ribi said, “This is an important example of the expanded potential use of our products, and provides us with the opportunity to greatly increase our revenues within the next two or three years. We are extremely pleased with the innovativeness of our scientific staff in developing products with broad market potential and in pursuing them with vigor.”
Results of preclinical studies carried out by company scientists show that certain of Ribi ImmunoChem’s biological response modifiers (BRMs), which include mixtures containing Detox, are effective in treating warts in animals. Detox, the first human anti-tumor product developed by the company, is now in U.S. Food and Drug Administration (FDA) Phase II human clinical trials for treatment of malignant melanoma and head and neck tumors.
The company plans to begin Phase II/III human clinical trials with Detox to treat venereal and genital warts within the next four to six months. The trials are expected to be carried out under the company’s Investigational New Drug (IND) application on file with the FDA. If successful in treating venereal and genital warts, the company then plans to initiate clinical trials on common warts (verruca vulgaris) in humans.
venereal and genital warts are believed to be the fastest-growing sexually transmitted disease in the United States, with the disease occurring about equally in men and women. Current estimates place the total number of patients affected in the United States at between 500,000 and 2 million. Statistics compiled by the Centers for Disease Control (CDC) indicate that up to 7 percent of women with chronic venereal and genital warts eventually develop cervical cancer.
“Therapy with Detox should have a significant effect on the incidence of venereal and genital warts,” said J.A. Rudbach, the company’s product development director. Current treatments such as surgery, cryosurgery, electrocautery and the use of certain drugs generally are not capable of eliminating the possibility of recurrence of the disease.
“The mode of action of Detox is such that its use, in addition to eliminating the primary growth, should also stimulate the patient’s own immune system to eliminate secondary growths and prevent recurrences,” Rudbach said.
Ribi ImmunoChem Research Inc., a biopharmaceutical company founded in 1981, is a leader in the development of general immune stimulators for human and veterinary use in an effort to fight malignant and infectious diseases.