Washington Editor

Patients participating in a Phase III study of Impavido, a proposed treatment for the severe skin disease cutaneous Leishmaniasis, had a higher cure rate than patients in the placebo group.

Impavido (miltefosine) is made by Frankfurt, Germany-based Zentaris AG, a subsidiary of AEterna Laboratories Inc., of Quebec City, Quebec. The product recently was approved in India as the first oral treatment for the life-threatening visceral form of Leishmaniasis. Impavido is pending approval in Bangladesh.

Study results released by AEterna Tuesday involved the cutaneous form of the disease, prominent in certain South American countries. Data showed that the average cure rate after treatment with Impavido was 70 percent (without medication, the cure rate is 20 percent to 30 percent due to the body's natural immune system). Zentaris intends to include those data in a regulatory package scheduled to be filed soon in Colombia and Guatemala.

Jurgen Engel, Zentaris' managing director and AEterna's vice president, global research and development and chief operating officer, told BioWorld Today Leishmaniasis is a tropical disease that affects people in places such as India, Bangladesh, Nepal, Pakistan, Africa, South America and Central America. The illness would not likely impact people living in the U.S., so the company does not intend to file for regulatory approval there.

AEterna said more people suffer from the cutaneous form of the disease, which can become chronic and severely disfiguring.

"There are treatments available where you have to inject highly toxic compounds with a lot of side effects, and those treatments require hospitalization," Engel said. "We are the first to develop an oral treatment without the necessity of hospitalization and with the reduction of treatment cost."

An oral product is desired in many of those developing countries because patients treated with toxic, intravenous drugs often contract other infections such as HIV, AEeterna said. Since Impavido has been on the market in India for such a short time, AEterna officials would not project the amount of money the product likely will generate.

In terms of pricing, Engel said public use (the government pays for it) treatment in India costs about $5,200.

The 133-patient Phase III trial of Impavido was a randomized, double-blind, placebo-controlled study conducted in Colombia and Guatemala. Eighty-nine patients were in the treatment group compared with 44 in the placebo group.

According to the company, cure from the disease was assessed at six months after the end of treatment; all skin lesions had to be healed and no new skin lesions were allowed to appear. Patients with newly diagnosed cutaneous Leishmaniasis responded to treatment equally as well as patients who were not cured by prior therapy.

In other business, AEterna's lead cancer product, Neovastat, an angiogenesis inhibitor with multiple mechanisms of action, is being studied in a Phase III kidney trial and a Phase III non-small-cell lung cancer trial. Data should be available from the kidney trial by the end of 2003 and from the NSCLC trial in 2006.

Cetrotide, the company's drug marketed for in vitro fertilization, also is being studied in endometriosis, uterus myoma and enlarged prostate (BPH).

AEterna's stock (NASDAQ:AELA) fell 6 cents to close at $5.