WASHINGTON - Although the details of AVI BioPharma Inc.'s most recent animal data for its RNA-based influenza therapeutic candidate AVI-7100 (formerly AVI-7367) have yet to be revealed, the U.S. Defense Threat Reduction Agency (DTRA) was confident enough to award the company a new contract worth up to $18 million to advance development of the drug through to early human safety testing, said CEO Dave Boyle.
News of the award had little effect on the company's shares (NASDAQ:AVII), which lost just 2 cents Monday, to close at $1.37.
AVI-7100 is being developed as a medical countermeasure against the pandemic H1N1 influenza virus, or swine flu, in cooperation with the Department of Defense's Transformational Medical Technologies (TMT) program.
Bothell, Wash.-based AVI recently got a $4 million boost to its earlier contract with DTRA to support, in cooperation with TMT, expanded preclinical evaluation of AVI-7100 against H1N1, H5N1 (avian flu) and drug-resistant H1N1 and H3N2 seasonal flu strains.
But the new contract will fund studies enabling an investigational new drug application, testing of an intranasal delivery formulation and a Phase I trial to obtain human safety data to support potential use of AVI-7100 under an emergency use authorization, Boyle told BioWorld Today.
Results from AVI's earlier single ferret study of AVI-7100 showed a statistically significantly greater reduction in viral titer and clinical scores in infected ferrets than was seen with the scrambled sequence control, the saline control or the positive control with Genentech Inc.'s Tamiflu (oseltamivir), the company reported.
AVI expects to reveal the results from the follow-up study in the next couple of months, Boyle said.
He noted that AVI initially began work on AVI-7100 as part of a test of the firm's ability to rapidly respond to a viral threat, such as the H1N1 pandemic, which quickly circulated around the globe last year and continues to be a threat, according to the World Health Organization (WHO).
The Centers for Disease Control and Prevention last month reported that from Aug. 30, 2009, to April 3, 2010, there were up to 403,000 H1N1 flu-associated hospitalizations in the U.S. and up to 18,300 deaths.
WHO said last week that it likely would be a year after the pandemic ends before the total global death count is known from the 2008-09 and 2009-10 flu seasons from the H1N1 pandemic strain. WHO reported that there have been 18,000 laboratory-confirmed deaths worldwide, but said that number is expected to sharply increase once all data have been examined.
The "interesting thing" about AVI-7100, Boyle said, is "that it may have very broad application to numerous flu strains. We believe that the target we are going after here is well-conserved across the different flu strains," he said.
Boyle insisted that AVI's PMOplus chemistry, which is based on phosphorodiamidate morpholino oligomers (PMOs), "is well-suited to overcome the issues of viral resistance," which he noted has become a problem with several drugs, most notably Tamiflu. PMOs are synthetic molecules based on a fundamental redesign of the natural nucleic acid structure and as such bind to the complementary sequences of mRNA by standard nucleic acid based-pairing.
"Generally, you are seeing a trend that our platform chemistries and our expertise in the antiviral and antibacterial areas are very, very strong," Boyle said. "They are well-appreciated by the Department of Defense, and obviously, we hope to apply that same platform to commercial applications as well."
Boyle noted that the company has two responses in with the DoD for requests for proposals for contracts to develop therapeutics against the Ebola and Marburg virus infections.
While the company has not disclosed the potential worth of those awards, the contracts are for development through to FDA licensure, he said.
"So you can imagine those are not small contracts with anticipating the normal costs of drug development," Boyle said.