Press release
SIGA Announces Start of TPOXX® Post-Exposure Prophylactic (“PEP”) Clinical Trials
NEW YORK, March 02, 2022 (GLOBE NEWSWIRE) -- SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage pharmaceutical company focused on the health
About this update from Siga Technologies Inc.
[{"type":"text","content":"NEW YORK, March 02, 2022 (GLOBE NEWSWIRE) -- SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage pharmaceutical company focused on the health security market, today announced that it has initiated the clinical program to support a U.S. Food and Drug Administration (FDA) label expansion for Post-Exposure Prophylaxis (“PEP”) for oral TPOXX®, approved in July 2018 for the treatment of smallpox. The first study is a comparison of the enrolled participants’ immune response with the Jynneos smallpox vaccines compared with the immune response with Jynneos while on TPOXX treatment. The study is designed to determine if TPOXX interferes with the development of an effective immune response to the vaccine. A second clinical study, also expected to commence in 2022, will look at developing an expanded safety dataset to support 28 day dosing of TPOXX for the post-exposure prophylaxis indication compared with the currently approved 14 days for treatment of smallpox indication. “The use of TPOXX for post-exposure prophylaxis has always been an important opportunity for TPOXX use in an outbreak of smallpox,” said Dr. Phil Gomez, CEO of SIGA. “This was highlighted by the US Government during our initial 2011 procurement, and discussed extensively at our FDA Advisory committee meeting in 2018 where TPOXX received a unanimous vote to recommend approval for treatment of smallpox. The COVID-19 pandemic has also shown vaccine hesitancy is a real issue for pandemic response, and the balance of vaccines and anti-viral drugs in stockpiles must be reevaluated in light of current experience.” SIGA has been collaborating with the U.S. Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) to develop the PEP indication, and this work is supported by an approximately $26 million R&D contract. “There have been long-standing concerns that smallpox could be used as a bioweapon,” said Col. Ryan Eckmeier, the Joint Project Manager for CBRN Medical. “This PEP indication could help protect a wider range of warfighters against that threat.” On July 13, 2018, the FDA approved oral TPOXX for the treatment of smallpox to mitigate the impact of a potential outbreak or bioterror attack. In December 2021, oral TPOXX was approved for the same indication by Health Canada. Tecovirimat (TPOX...