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(Liposomal Ciprofloxacin)

Novel Anti-Bioterrorism Therapy for the Localized Treatment and Prevention of Inhalation Anthrax

The third of our liposomal ciprofloxacin programs is for the prevention and treatment of pulmonary anthrax infections. Anthrax spores are naturally occurring in soil throughout the world. Anthrax infections are most commonly acquired through skin contact with infected animals and animal products or, less frequently, by inhalation or ingestion of spores. With inhalation anthrax, once symptoms appear, fatality rates are high even with the initiation of antibiotic and supportive therapy. Further, a portion of the anthrax spores, once inhaled, may remain dormant in the lung for several months and germinate. Anthrax has been identified by the Centers for Disease Control as a likely potential agent of bioterrorism. In the fall of 2001, when anthrax-contaminated mail was deliberately sent through the United States Postal Service to government officials and members of the media, five people died and many more became sick. These attacks highlighted the concern that inhalation anthrax as a bioterror agent represents a real and current threat.

Ciprofloxacin has been approved by the FDA for use orally and via injection for the treatment of inhalation anthrax (post-exposure) since 2000. Our ARD-1100 research and development program has been funded by Defence Research and Development Canada, or DRDC, a division of the Canadian Department of National Defence. We believe that our product candidate may potentially be able to deliver a long-acting formulation of ciprofloxacin directly into the lung and could have fewer side effects and be more effective to prevent and treat inhalation anthrax than currently available therapies.

Development

We began our research into liposomal ciprofloxacin under a technology demonstration program funded by the DRDC as part of their interest in developing products to counter bioterrorism. The DRDC had already demonstrated the feasibility of inhaled liposomal ciprofloxacin for post-exposure prophylaxis of Francisella tularensis, a potential bioterrorism agent similar to anthrax. Mice were exposed to a lethal dose of F. tularensis and then 24 hours later were exposed via inhalation to a single dose of free ciprofloxacin, liposomal ciprofloxacin or saline. All the mice in the control group and the free ciprofloxacin group were dead within 11 days post-infection; in contrast, all the mice in the liposomal ciprofloxacin group were alive 14 days post-infection. The same results were obtained when the mice received the single inhaled treatment as late as 48 or 72 hours post-infection. The DRDC has funded our development efforts to date and additional development of this program is dependent on negotiating for and obtaining continued funding from DRDC or on identifying other collaborators or sources of funding. We plan to use our preclinical and clinical safety data from our CF program to supplement the data needed to have this product candidate considered for approval for use in treating inhalation anthrax and possibly other inhaled life-threatening bioterrorism infections.

We anticipate developing this drug for approval under FDA regulations relating to the approval of new drugs or biologics for potentially fatal diseases where human efficacy studies cannot be conducted ethically or practically. These regulations allow for a drug to be evaluated and approved by the FDA on the basis of demonstrated safety in humans combined with studies in animal models to show effectiveness. Our intention is to continue the development of this potential product for the treatment and prevention of anthrax only if we can obtain future funding for it from a partner, or secure a government contract for it.

Scientific Publications
Cipolla D. et al. Development of Liposomal Ciprofloxacin to Treat Lung Infections. Pharmaceutics. 2016. 8(1): 6. | Supplementary Material

Cipolla D. et al. Emerging Opportunities for Inhaled Antimicrobial Therapy. J Antimicro. 2015. 1(1): 104.

Norville IH. et al. Efficacy of liposome-encapsulated ciprofloxacin in a murine model of Q fever. Antimicrob Agents Chemother. 2014. 58: 5510-5518.

Hamblin KA. et al. The Potential of Liposome-Encapsulated Ciprofloxacin as a Tularemia Therapy. Front Cell Infect Microbiol. 2014. 4: 79

Hamblin KA. Et al. Liposome encapsulation of ciprofloxacin improves protection against highly virulent Francisella tularensis strain Schu S4. Antimicrob Agents Chemother. 2014. 58: 3053-3059.

Blanchard, J. Pulmonary Drug Delivery as a First Response to Bioterrorism. RDD X. Dalby R.N. et al. (eds). 2006. 73-82.

Educational Links
For more information on inhalation anthrax, refer to the following resources:
U.S. Centers for Disease Control
MedlinePlus

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