Nanotherapeutics, Inc., today announced that it has been awarded a $30.9 Million, 5-year contract from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to develop an inhaled version of the injectable antiviral drug, cidofovir, for non-invasive, post-exposure prophylaxis and treatment of the Category A bioterrorism agent smallpox (Variola major). Since transmission of smallpox occurs through inhalation of airborne variola virus, usually droplets expressed from the oral, nasal, or pharyngeal mucosa of an infected person, non-invasive anti-viral treatment alternatives with proven agents (cidofovir) are needed. Development of inhaled cidofovir will also provide an alternative for those who have contraindications to the currently approved smallpox vaccination such as severe exfoliative skin diseases, immunosuppression from many sources, and pregnancy. Inhaled cidofovir could decrease the proportion of the population that would remain susceptible to smallpox due to their inability to be vaccinated, and has been shown in multiple studies to be highly efficacious against various pox models compared to injectable administration, which results in lower pulmonary levels, possible nephrotoxicity, and requires a health-care worker to implement treatment.
Nanotherapeutics has assembled a highly-esteemed consortium of experts and organizations to support the preclinical development program including Tulane National Primate Research Center, Respirics, Next Breath, and Lovelace Respiratory Research Institute. David L. Gardner, Ph.D., an expert with over 30 years experience in inhalation and delivery technologies, will lead the program at Nanotherapeutics as the new Director of Inhalation Product Development. Cidofovir will be provided under an agreement with Gilead Sciences, Inc. This project has been funded in whole or in part with Federal funds from the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) under Contract No. HHSN272200900015C.
Nanotherapeutics, Inc. is a privately held specialty biopharmaceutical company. Its product pipeline includes, an FDA-approved injectable biologic product (OrigenTM DBM, marketing partner Orthofix), an FDA filed product (NanoFUSETM bone graft), and two products in clinical trials (NanoDOXTM and NanoBUPTM). The company also has in-house GMP manufacturing to support additional products. Nanotherapeutics was previously awarded a $20 million contract in 2007 to develop an inhaled version of gentamicin for the post-exposure prophylaxis and treatment of tularemia and plague, both Category A bioterrorism agents. The 10-year old company employs several platform technologies to manipulate and enhance the properties of drugs, has an experienced management and development team, and a pipeline of clinical and pre-clinical pharmaceutical and biologic products.