SEATTLE--(BUSINESS WIRE)--Jan. 13, 2003--Corixa Corporation (Nasdaq: CRXA - News), a developer of immunotherapeutics, and the Infectious Disease Research Institute (IDRI), today announced that they have initiated a Phase I clinical trial to test the safety and tolerability of an investigational vaccine to treat or protect against various forms of human leishmaniasis.
The investigational vaccine, identified as Leish-111f, consists of a fusion of three Leishmania proteins in combination with Corixa's proprietary MPL-SE adjuvant. The Phase I double-blind, randomized study is designed to evaluate the safety of Leish-111f plus adjuvant, administered subcutaneously to healthy adult volunteers, at three dose levels as compared to adjuvant-alone and placebo-alone groups. The study will evaluate the safety of escalating doses of the vaccine, as well as its effects on the immune response. This Phase I trial is being conducted in the United States under an FDA Investigational New Drug Application (IND).
"The initiation of the Phase I trial under a U.S. IND is an important milestone in developing a vaccine for a neglected disease that kills up to an estimated 500,000 people, mostly children, every year," stated Steven Reed, executive vice president and chief scientific officer of Corixa.
The development of this potential vaccine was achieved through a combination of public and private funding. Funding to IDRI was provided by a $15 million grant from the Bill and Melinda Gates Foundation and grants from the National Institutes of Health (NIH). Additional funding to Corixa was obtained from an $850,000 NIH grant.
Leish-111f and MPL-SE
Leish-111f is a trifusion recombinant protein consisting of three Leishmania protein antigens: TSA, LmSTI1 and LeIF. Corixa's monophosphoryl lipid A (MPL(TM)) is a derivative of the lipopolysaccharide of Salmonella minnesota, used as an adjuvant in vaccine formulations in several ongoing human clinical trials including those for malaria, hepatitis B, HIV and HSV. When administered in conjunction with vaccines for these diseases, Corixa's MPL adjuvant triggers an elevated immune response, enhancing the body's recognition and response to the vaccine. MPL-SE is a formulation of MPL with squalene oil, excipients, and sterile water-for-injection to produce a stable emulsion.
About Leishmaniasis
The World Health Organization has identified leishmaniasis as a major public health problem in many countries of Africa, Asia and Latin America, with an estimated 12 million people affected and 1.5 to 2 million new cases of the disease appearing each year mostly in children. Leishmaniasis is a skin and visceral disease caused by the parasite Leishmania, which is carried by sand flies. Available treatments for leishmaniasis are expensive or have serious associated toxicities and may lead to the development of drug-resistant parasites. Although not endemic to the United States, development of a vaccine against leishmaniasis may become useful for U.S. military stationed overseas as well as travelers. ...
Was the highlighted comment really necessary?? |
