Immtech Completes Malaria Prevention Trial
Immtech Pharmaceuticals has completed its first malaria prevention (or "malaria challenge") trial of pafuramidine, Immtech's oral drug candidate.
The exploratory study was designed to determine whether the Company should focus on commercializing a blood-stage or a liver-stage malaria prevention drug. The information obtained from this study is needed by Immtech in order to design the appropriate subsequent trials for pafuramidine's registration to target malaria prevention, and by the Independent Ethics Committees and the regulatory agencies in order to review and approve subsequent studies for this indication.
Malaria prevention potentially represents a significant market opportunity for Immtech. Datamonitor estimates the market potential for a product with pafuramidine's expected profile to exceed US $1.0 billion globally.
Eric L. Sorkin, Immtech's Chairman & Chief Executive Officer stated, "The completion of this study gives us a clear direction in our plans to commercialize pafuramidine as a malaria prevention drug. The market for malaria prevention represents an enormous market opportunity which Immtech intends to pursue vigorously."
The malaria parasite initially travels to the liver where it grows for about 7 days before spreading to the blood. Malaria prevention drugs can work by preventing the infection in the liver or in the blood stream. A liver stage regimen would continue for 7 days after travel and a blood stage regimen would continue for 30 days after travel. The results of this study indicate that the Company should commercialize a prevention drug to target the blood stage form of malaria.
In this study a single dose of 100mg of pafuramidine was administered once only to prevent malaria infection in the liver, which represents the earliest stage of infection. Healthy volunteers were recruited for the trial because they are representative of travelers to malaria-endemic areas. The 100 mg dosing was determined based on results of blood levels of the active drug form of pafuramidine recorded in previous human and animal model studies. The low dosages and rigorous study design were used to help distinguish the effect of pafuramidine on liver stage infection versus the effect demonstrated on blood stage infection.
Carol Olson, MD, PhD, Immtech's Sr. Vice President and Chief Medical Officer, stated, "A prior study of pafuramidine given as 100 mg for 5 days in uncomplicated malaria showed a 96% cure rate 28 days after treatment. Based on those results, we believe that continued treatment of travelers with pafuramidine for 30 days after travel will be protective against blood stage malaria. The malaria challenge study was designed specifically to evaluate the effect of pafuramidine on the liver stage, and to have no effect on the blood stage of malaria infection. With the results of this study we can now advance our malaria prevention program with the goal of preventing blood stage infection, which would represent a major advance in global health. We will work with our advisors to design the appropriate trials that will be acceptable to the US Food and Drug Administration as well as to regulatory agencies in other countries."
Participants in the randomized placebo controlled trial were treated with placebo (sugar pill), a dose of pafuramidine that was expected not to be effective (administered eight days before subjects were exposed to malaria), and a dose of pafuramidine that was considered to be potentially effective (administered one day prior to exposure).