SIGA Technologies, Inc. (NASDAQ: SIGA) shares are trading higher after the company announced that its lead smallpox drug, ST-246, has passed another milestone by demonstrating 100% protection against death in cynomolgus monkeys showing signs of infection with monkeypox virus as part of a primate trial. The study was conducted at the U.S. Army Medical Research Institute of Infectious Diseases.
The study included a wide range of doses, all of which successfully prevented death, including a dose that was one one-hundredth of the dose given in prior primate trials. The amount of virus introduced into each animal is usually fatal absent ST-246 (all of the control subjects died), and all of the animals had developed fever and skin lesions prior to the administration of SIGA’s drug.
In the study, once-daily, oral administration of ST-246 beginning 72 hours after infection protected cynomolgus monkeys from death following intravenous dosing with a lethal dose of monkeypox virus. ST-246 reduced lesion formation, reduced viral load and prevented death in all animals with no obvious toxicity. Furthermore, the test included a range of dosages (100 mg/kg to 3 mg/kg) of ST-246, and all were effective.
SIGA previously announced that ST-246 has been shown to be safe to administer to humans as a once-a-day pill. ST-246 has also demonstrated 100% disease protection in several mouse models of infection, which results SIGA will use, along with additional tests yet to be completed, to fulfill the U.S. Food and Drug Administration’s "Animal Efficacy Rule." In December 2005, the FDA granted "fast-track" status to ST-246.
Shares of SIGA are up 16% in after-hours trading at $4.20, still within its $1.40 to $6.04 trading range over the last 52-weeks. The company had a $121 million market cap as of the close, and it had $9.277 million cash on hand as of June 30, 2007. It is always worth noting that "primate" tests and animal studies do not assure that humans will react the same, although the "completely prevents" aspect is quite promising. Small pox is also one of the areas that the government will be funding for one of our nightmare terror or biological scenarios, because this is mostly deemed as eradicated as far as the public is concerned.
Jon C. Ogg
September 26, 2007
Jon Ogg produces the 24/7 Wall St., LLC Special Situation Investing Newsletter; he does not own securities in the companies he covers.