Tekmira Pharmaceutical just announced second quarter earnings that missed expectations.
Tekmira said that it is, “carefully evaluating options for use of our investigational drug within accepted clinical and regulatory protocols.”
Shares of the company, which is working to make a drug to treat Ebola, which has currently claimed the lives of more than 1,000 in Africa, had been halted ahead of the announcement.
According to the Nasdaq, shares of Tekmira are scheduled to resume trading at 5:00 pm ET.
Regarding its Ebola treatment, Tekmira said in its earnings press release that:
- The single ascending dose portion of the TKM-Ebola Phase I clinical trial has been successfully completed in healthy human volunteers. As per the protocol maximum tolerated dose (MTD) was established to be 0.3 mg/kg for healthy subjects without steroid premedication.
- In July, we received notice from the U.S. Food & Drug Administration (FDA) that our TKM-Ebola program was on clinical hold. Subsequently, the company received written notice from the FDA modifying the clinical hold to a “partial clinical hold,” allowing for the potential use of TKM-Ebola in individuals who have a confirmed or suspected Ebola infection. The company remains on clinical hold as it relates to the multiple-ascending dose portion of the Phase I clinical study in healthy volunteers with TKM-Ebola. The company expects this matter to be resolved by Q4 2014.
- Our therapeutic, TKM-Ebola, is currently an unapproved agent and the regulatory framework to support its use in Africa has not yet been established. Given the severity of the situation, we are carefully evaluating options for use of our investigational drug within accepted clinical and regulatory protocols. This includes discussions with government agencies and NGO’s, including the WHO, in various countries on the potential use of TKM-Ebola to treat Ebola virus infected individuals. There can be no assurance that an appropriate framework for the use of this product will be found. We will continue to provide updates as necessary when clinical and regulatory pathways become confirmed.
In the second quarter, the company lost $US0.28 per share compared to analyst expectations for $US0.26 on revenue of $US1.8 million against expectations for $US3.69 million.
Tekmira shares were halted last Thursday ahead of an announcement that the FDA has loosened a hold on the company’s Ebola treatment.
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