OneWorld Health VL Project Team

Ahvie Herskowitz, M.D.
Philippe Desjeux, Ph.D., M.D.
Raj Shankar Ghosh
Vineeta Gulati
Megan Wysong Harris, MPH
Barbara Hickingbottom, MD, JD
Tasleem Kachra, MPH, MBA
Heather Kelly, MPA
Esther Kwan, MA
Helen Matzger, MPH
Michael McGuffey
Bao Nguyen
Rhonda Sarnoff, DrPH
Karen Schlein

Program Consultants

Paromomycin is an aminoglycoside antibiotic with anti-parasitic activity. Injectable paromomycin has been tested by OneWorld Health as a treatment for visceral leishmaniasis (VL), also known as kala-azar, occurring on the Indian subcontinent.

OneWorld Health completed a phase 3 clinical trial of 667 patients in November 2004, the largest trial ever performed for this disease, in collaboration with the Special Programme for Research and Training in Tropical Diseases of the World Health Organization (WHO/TDR). Beginning in June 2003, the phase 3 trial enrolled patients in Bihar, India, with visceral leishmaniasis that was confirmed by the presence of the parasite in the spleen or bone marrow. They were randomized in a ratio of 3 to 1 to receive either paromomycin or the current standard therapy in India, amphotericin B. The safety profile of paromomycin is being compared to that of amphotericin B, and the final clinical cure rates at six months after treatment will be determined for both drugs.

The trial was conducted at four centers of excellence in Bihar: the Kala-azar Medical Research Centre and the Kalaazar Research Centre in Muzzafarpur and the Kalaazar Research Centre and the Rajendra Memorial Research Institute in Patna.

OneWorld Health submitted an application for regulatory approval in India for injectable paromomycin in Q2 2006. From the large-scale clinical trials, OneWorld Health believes paromomycin is both safe and effective.

OneWorld Health is working with a division of the International Dispensary Association (IDA), a not-for-profit drug supply agency based in the Netherlands, to arrange for manufacture injectable paromomycin in India. Through an Indian manufacturer, Gland Pharma Ltd., in Hyderabad, OneWorld Health and IDA expect to supply the needs of the worldwide paromomycin market.

Background of Paromomycin

Paromomycin sulfate is best known for its use as a broad-spectrum aminoglycoside antibiotic. First isolated from culturable filtrates of Streptomyces krestomuceticus by Farmitalia Carlo Erba, it was initially named “aminosidine.” Injectable aminosidine (Gabbromicina) was marketed worldwide in 1959. At the same time, Parke-Davis developed and marketed the drug “paromomycin” (Humatin) as an oral product worldwide. In 1961, paromomycin was shown to be the same as aminosidine.

The spectrum of activity of paromomycin encompasses most Gram-negative and many Gram-positive bacteria, some protozoa and many cestodes. It is poorly absorbed from the gut, so that oral dosing is restricted to the clearing of susceptible bacteria, protozoa and worms from the intestinal lumen. Administered parenterally, it distributes into extravascular fluid space and is effective for treating infections located in most but not all parts of the body.