Individuals infected with the Ebola virus might be able to get access to TKM-Ebola, a drug that’s been held up in Phase I clinical trials by the FDA.
Shares of Tekmira Pharmaceuticals, the company behind the drug, were halted at around 4:00 p.m. ET.
Here’s what management is said in its 4:45 p.m. ET press release: “[Tekmira] today announced that the U.S. Food & Drug Administration (FDA) has verbally confirmed they have modified the full clinical hold placed on the TKM-Ebola Investigational New Drug Application (IND) to a partial clinical hold. This action enables the potential use of TKM-Ebola in individuals infected with Ebola virus.”
“We are pleased that the FDA has considered the risk-reward of TKM-Ebola for infected patients,” said Tekmira CEO Mark Murray. “We have been closely watching the Ebola virus outbreak and its consequences, and we are willing to assist with any responsible use of TKM-Ebola. The foresight shown by the FDA removes one potential roadblock to doing so.”
The $US300 million biotech firm has received lots of attention as the deadly virus ravages people in West Africa.
“Earlier this month, the [U.S. Food and Drug Administration] put a hold on a Tekmira Pharmaceuticals Corp clinical trial of TKM-Ebola, one of the few Ebola treatments advanced enough to be tested in people,” reported Reuters’ Julie Steenhuysen.
Steenhuysen spoke with a University of Texas doctor who said that it “works great in monkeys in the lab.”
The stock has been trading in a wide range in recent weeks, swinging between $US5.08 and $US31.48 in the past year.
Shares closed at $US14.23, up 6.5% for the day.
Here’s the full press release:
August 7, 2014
FDA Modifies Tekmira’s TKM-Ebola Clinical Hold to Partial Hold
Enabling Use of Tekmira’s Investigational Therapeutic in Ebola-Infected Patients
VANCOUVER, British Columbia, Aug. 7, 2014 (GLOBE NEWSWIRE) — Tekmira Pharmaceuticals Corporation (Nasdaq:TKMR) (TSX:TKM), a leading developer of RNA interference (RNAi) therapeutics, today announced that the U.S. Food & Drug Administration (FDA) has verbally confirmed they have modified the full clinical hold placed on the TKM-Ebola Investigational New Drug Application (IND) to a partial clinical hold. This action enables the potential use of TKM-Ebola in individuals infected with Ebola virus.
“We are pleased that the FDA has considered the risk-reward of TKM-Ebola for infected patients. We have been closely watching the Ebola virus outbreak and its consequences, and we are willing to assist with any responsible use of TKM-Ebola. The foresight shown by the FDA removes one potential roadblock to doing so,” said Dr. Mark Murray, CEO and President, Tekmira Pharmaceuticals. “This current outbreak underscores the critical need for effective therapeutic agents to treat the Ebola virus. We recognise the heightened urgency of this situation, and are carefully evaluating options for use of our investigational drug within accepted clinical and regulatory protocols.”
TKM-Ebola is being developed by Tekmira Pharmaceuticals and the U.S. Department of Defence’s Medical Countermeasure Systems BioDefense Therapeutics (MCS-BDTX) Joint Product Management Office.
The Company remains on clinical hold as it relates to the multi-ascending dose portion of the Phase I clinical study in healthy volunteers with TKM-Ebola. “We are focused on an expedient resolution of this so that we can advance our TKM-Ebola to evaluate the multiple ascending dose regimen,” said Dr. Mark Murray, CEO and President, Tekmira Pharmaceuticals.
About the TKM-Ebola Phase I Clinical Trial
The TKM-Ebola Phase I clinical trial is a randomised, single-blind, placebo-controlled study and involves single ascending doses and multiple ascending doses of TKM-Ebola. The study is assessing the safety, tolerability and pharmacokinetics of administering TKM-Ebola to healthy adult volunteers without administering any steroid pre-medications.
About TKM-Ebola, an Anti-Ebola Virus RNAi Therapeutic
TKM-Ebola, an anti-Ebola virus RNAi therapeutic, is being developed under a $US140 million contract with the U.S. Department of Defence’s Medical Countermeasure Systems BioDefense Therapeutics (MCS-BDTX) Joint Product Management Office. Earlier preclinical studies were published in the medical journal The Lancet and demonstrated that when siRNA targeting the Ebola virus and delivered by Tekmira’s LNP technology were used to treat previously infected non-human primates, the result was 100 per cent protection from an otherwise lethal dose of Zaire Ebola virus (Geisbert et al., The Lancet, Vol 375, May 29, 2010). In March 2014, Tekmira was granted a Fast Track designation from the U.S. Food and Drug Administration for the development of TKM-Ebola.
About Joint Project Manager Medical Countermeasure Systems (JPM-MCS)
This work is being conducted under contract with the U.S. Department of Defence Joint Project Manager Medical Countermeasure Systems (JPM-MCS). JPM-MCS, a component of the Joint Program Executive Office for Chemical and Biological Defence, aims to provide U.S. military forces and the nation with safe, effective, and innovative medical solutions to counter chemical, biological, radiological, and nuclear threats. JPM-MCS facilitates the advanced development and acquisition of medical countermeasures and systems to enhance biodefense response capability. For more information, visit www.jpeocbd.osd.mil.
Tekmira Pharmaceuticals Corporation is a biopharmaceutical company focused on advancing novel RNAi therapeutics and providing its leading lipid nanoparticle (LNP) delivery technology to pharmaceutical partners. Tekmira has been working in the field of nucleic acid delivery for over a decade and has broad intellectual property covering LNPs. Further information about Tekmira can be found at www.tekmira.com. Tekmira is based in Vancouver, B.C. Canada.
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