Nanotherapeutics, Inc., has
announced that it has been awarded a $20 Million 4-year contract from
the National Institute of Allergy and Infectious Diseases (NIAID), part
of the National Institutes of Health (NIH), and the Biomedical Advanced
Research and Development Authority (BARDA) to develop an inhaled
version of the injectable drug, gentamicin, a broad-spectrum antibiotic
that is used as a first-line therapy for pneumonic plague and
tularemia, Category A bioterrorism agents. Both diseases are highly
infectious and could pose a serious danger if used as an aerosolized
biological weapon.
Using its novel particle formulation, the company has
developed NanoGENT™, an inhaled dry-powder formulation of
gentamicin, to provide early treatment for exposure to biological
warfare agents, as well as TB and other respiratory infections. In the
event of an accidental or deliberate exposure to these agents,
noninvasive drug delivery systems, such as improved inhaled and nasal
delivery would be especially beneficial for administering wide-spread
immediate post-exposure prophylaxis and treatment using disposable
multi-dose inhalers with adequate shelf-life stability.
James D. Talton, Ph.D., President and C.E.O. of
Nanotherapeutics and co-founder of the company said, “We are
very pleased to receive this contract to fund this product development
program. The continued support from the NIAID and BARDA of
Nanotherapeutics’ proprietary drug delivery systems is a
terrific endorsement of our technologies and manufacturing
capabilities. The continued development of NanoGENT™ with our
partners Respirics, Next Breath, Lovelace Respiratory Research
Institute, and i3Research is a strategically important milestone for
the company as it demonstrates the utility of our technology to meet a
significant medical need. We are confident we will be able to develop a
novel improved formulation that can rapidly and effectively provide
therapeutic results into a viable product.”
Gentamicin, the front-line therapy for plague and tularemia,
is a generic drug approved by the FDA for injection. For many years it
has been used in a saline nebulized version to treat Pseudomonas
respiratory infections, particularly in patients with cystic fibrosis.
Nanotherapeutics and its collaborators will continue the clinical
development of NanoGENT™ and expect to bring it to human
clinical trials to evaluate the safety and pharmacokinetics in the
fourth year of its NIAID/BARDA contract.
In 2005, Nanotherapeutics received funding from National
Institute on Drug Abuse (NIDA) to develop an oral medication to treat
opiate addiction. The company also received funding from the NIAID, as
part of the NIH research program on Medical Countermeasures against
Radiological and Nuclear Threats, to test the oral delivery of DTPA, an
injectable treatment, and from Project Bioshield for preliminary
testing of NanoGENT™. Nanotherapeutics has one approved
injectable product and several products in advanced development,
manufactured in-house under cGMP. This project has been funded in whole
or in part with Federal funds from the National Institute of Allergy
and Infectious Disease, National Institutes of Health (NIAID) and the
Biomedical Advanced Research and Development Authority (BARDA),
Department of Health and Human Services (DHHS), under Contract No.
HHSN27220070030C"
15th October 2007