LONDON--(BUSINESS WIRE)--Gilead Sciences, Inc. (NASDAQ:GILD) today confirmed that the company fulfilled a request for compassionate access to GS-5734, a novel nucleotide analogue in development for the potential treatment of Ebola Virus Disease (EVD). The request was received last week and drug was shipped later the same day. The compound is currently being provided to a female patient in the United Kingdom, as described earlier today by officials from the Royal Free Hospital in London.
“It is very encouraging to hear that the patient in question is doing better and is no longer in critical condition. Our thoughts and wishes for continued recovery are with her, with her family and the excellent medical team at Royal Free Hospital,” commented Norbert Bischofberger, PhD, Gilead’s Executive Vice President, Research and Development and Chief Scientific Officer. “We recognize the urgent need for treatments to address Ebola and we are working with collaborators to advance development of GS-5734 as quickly as possible.”
GS-5734 was discovered as part of Gilead’s program to screen compounds in its libraries for activity against a range of potential emerging viruses, including Ebola. In collaboration with the Centers for Disease Control and Prevention (CDC) and the United States Army Medical Research Institute of Infectious Diseases (USAMRIID), the company identified GS-5734 in vitro activity against the Ebola virus.
In animal studies conducted at USAMRIID, treatment initiated on day 3 post-infection with Ebola virus resulted in 100 percent survival of monkeys. Data from these studies were recently presented at the annual Interscience Conference of Antimicrobial Agents and Chemotherapy / International Congress of Chemotherapy and Infection (ICAAC/ICC) meeting and at ID Week. Gilead recently initiated a Phase 1 clinical trial in healthy human volunteers to determine the safety, tolerability and pharmacokinetics of GS-5734.
Ebola represents a global public health crisis, and Gilead is working with USAMRIID and a number of private and public health entities to determine next steps on how to advance evaluation of GS-5734. In the event that the compound proves to be safe and effective in humans, Gilead plans to work to enable access as broadly and quickly as possible. In the interim, the company will review any requests for compassionate access on a case by case basis.
GS-5734 is an investigational compound that has not been proven safe and effective for EVD; additionally, its clinical effect in this particular patient case cannot be determined.
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases. Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California.
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2015, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
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