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.