Advanced Life Sciences Announces US Army Collaboration to Research and Develop Restanza for the Treatment of Malaria
CHICAGO, Nov. 2, 2010 /PRNewswire/ — Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board: ADLS), a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, today announced that it has entered into a Cooperative Research and Development Agreement (“CRADA”) with The Walter Reed Army Institute of Research. The purpose of this CRADA is to allow The Walter Reed Army Institute of Research to perform advanced animal efficacy testing of Restanza(TM) (cethromycin), the Company’s novel oral antibiotic, against various Plasmodium species that cause malaria. This CRADA is built on the positive in vitro and in vivo efficacy results that Restanza demonstrated in initial studies with Walter Reed.
“Developing new treatments for malaria is a high-priority for the US military because of malaria’s global prevalence, debilitating nature, potential lethality, and tendency to become resistant to current drugs,” stated Michael T. Flavin, Ph.D., chief executive officer of Advanced Life Sciences. “We share the US Army’s mission to protecting our troops in the field with novel therapies that can combat infectious diseases such as malaria. Advanced Life Sciences remains committed to developing Restanza as a new drug to protect public health and we are very pleased to expand our collaboration with the Walter Reed Army Institute of Research toward this goal.”
In May 2010, the Company announced that preliminary in vitro and in vivo studies had been conducted to access the efficacy of Restanza against the species of Plasmodium that cause malaria. In the in vitro study comparing Restanza to azithromycin, Restanza showed two to ten-fold greater efficacy against Plasmodium falciparum with the IC50 and IC90 levels, respectively, ranging from 0.2 to 2.7 and 0.6 to 6.2 ug/mL, regardless of chloroquine susceptibility. Most notably, in the in vivo study, Restanza showed 100% efficacy in treating mice infected with Plasmodium berghei and was approximately three-fold more potent than azithromycin at half of the same dose.
Malaria is a parasitic disease that is characterized by high fevers, shaking chills, flu-like symptoms, and anemia, and requires hospitalization. Malaria is typically caused by a parasite that is transmitted from one human to another by the bite of infected mosquitoes. Malaria can also be transmitted from a mother to her unborn baby and by blood transfusions. In humans, the parasites (sporozoites) travel to the liver where they mature and release another form, the merosoites, which enter the bloodstream and infect red blood cells. The parasites multiply inside the red blood cells, which then rupture within 48 to 72 hours, infecting more red blood cells. The first symptoms usually occur 10 days to four weeks after infection, though they can appear as early as eight days or as long as a year after infection.
Malaria is a serious health problem in much of the tropics and subtropics and represents a major disease hazard for travelers to these regions and other warm climates. The widespread prevalence of malaria in Africa poses a severe social and economic threat. The Centers for Disease Control and Prevention (CDC) estimates that there are 300-500 million cases of malaria each year, resulting in more than one million deaths, many among very young children. Conventional treatment includes chloroquine, quinidine or quinine. In some areas of the world, the parasites have developed resistance to antibiotic treatments (doxycycline, tetracycline or clindamycin, atovaquone plus proguanil, mefloquine or artesunate, or the combination of pyrimethamine and sulfaxcozine). This has led to difficulty in controlling both the rate of infection and spread of this disease, creating an urgent need for new, effective drug treatments as well as preventive measures.
Restanza is a novel, once-a-day, oral antibiotic that is in late stage development for the treatment of adults with mild-to-moderate community-acquired pneumonia (“CABP”) and biodefense pathogens. It has shown higher in vitro potency and a broader range of activity than macrolides against Gram-positive bacteria associated with respiratory tract infections and appears to be effective against penicillin-, macrolide- and fluoroquinolone-resistant bacteria. Restanza’s demonstrated potency and ability to overcome bacterial resistance may be due to its mechanism of action resulting in specificity for its bacterial target. In addition to its utility in CABP, Restanza is also being investigated for the prophylactic treatment of inhalation anthrax post-exposure and other high priority biodefense pathogens, including plague and tularemia. The FDA has designated Restanza as an orphan drug for the prophylactic treatment of inhalation anthrax post exposure, as well as for use in treating plague and tularemia, but the drug is not yet approved for these or any other indications.
About Advanced Life Sciences
Advanced Life Sciences is a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, cancer and respiratory diseases. The Company’s lead candidate, Restanza, is a novel once-a-day oral antibiotic in late-stage development for the treatment of respiratory tract infections including CABP and biodefense pathogens including anthrax, plague and tularemia. For more information, please visit us on the web at www.advancedlifesciences.com or follow us on twitter at http://twitter.com/advancedlifesci.
Any statements contained in this press release that relate to future plans, events or performance are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements represent our management’s judgment regarding future events. The Company does not undertake any obligations to update any forward-looking statements whether as a result of new information, future events or otherwise. Our actual results could differ materially from those discussed herein due to several factors including the success and timing of our clinical trials and our ability to obtain and maintain regulatory approval and labeling of our product candidates; our plans to develop and commercialize our product candidates; the loss of key scientific or management personnel; the size and growth of potential markets for our product candidates and our ability to serve those markets; regulatory developments in the U.S. and foreign countries; the rate and degree of market acceptance of any future products; the accuracy of our estimates regarding expenses, future revenues and capital requirements; our ability to obtain financing on terms acceptable to us; our ability to obtain and maintain intellectual property protection for our product candidates; the successful development of our sales and marketing capabilities; the success of competing drugs that become available; and the performance of third party collaborators and manufacturers. These and additional risks and uncertainties are detailed in the Company’s filings with the Securities and Exchange Commission.
SOURCE Advanced Life Sciences Holdings, Inc.