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Access to Tekmira’s Ebola Treatment Widened
Tekmira Pharmaceuticals Corporation announced that the FDA has authorized the company to provide TKM-Ebola for treatment under expanded access protocols to subjects with confirmed or suspected Ebola virus infections.
"Today we are reporting that, working closely with regulators in the United States and Canada, we have established a framework for TKM-Ebola use in multiple patients," said Dr. Mark J. Murray, Tekmira's President and CEO. “In the U.S., the FDA has granted expanded access use of TKM-Ebola under our investigational new drug application (IND) and Health Canada has established a similar framework, both of which allow the use of our investigational therapeutic in more patients."
"We have already responded to requests for the use of our investigational agent in several patients under emergency protocols, in an effort to help these patients, a goal we share with the FDA and Health Canada,” he added. “TKM-Ebola has been administered to a number of patients and the repeat infusions have been well tolerated. However, it must be kept in mind that any use of the product under expanded access does not constitute controlled clinical trials.
“These patients may be infected with a strain of Ebola virus which has emerged subsequent to the strain that our product is directed against, and physicians treating these patients may use more than one therapeutic intervention in an effort to achieve the best outcome," said Dr. Murray. "Our TKM-Ebola drug supplies are limited, but we will continue to help where we can, as we continue to focus on the other important objectives we have to advance therapies to meet the unmet needs of patients."
TKM-Ebola is an investigational therapeutic, being developed under an FDA approved IND, which is the subject of a partial clinical hold under which the FDA has allowed the potential use of TKM-Ebola in individuals with a confirmed or suspected Ebola virus infection.
Expanded access is the use of an investigational drug outside of a clinical trial to treat a patient, with a serious or immediately life-threatening disease or condition, who has no comparable or satisfactory alternative treatment options. FDA regulations allow access to investigational drugs for treatment purposes on a case-by-case basis for an individual patient, or for intermediate-size groups of patients with similar treatment needs who otherwise do not qualify to participate in a clinical trial.
TKM-Ebola, an anti-Ebola virus RNAi therapeutic, is being developed under a $140 million contract with the U.S. Department of Defense's Medical Countermeasure Systems BioDefense Therapeutics Joint Product Management Office.
Earlier preclinical studies published in the medical journal The Lancet demonstrated that when siRNA targeting the Ebola virus and delivered by Tekmira's technology were used to treat previously infected nonhuman primates, the result was 100% protection from an otherwise lethal dose of Zaire Ebola virus.
In March 2014, Tekmira was granted an FDA fast track designation for the development of TKM-Ebola.
Source: Tekmira; September 22, 2014.