Over the weekend, Spain announced that it imported a few doses of Mapp Biopharmaceutical’s ZMapp to treat a priest who was brought from Liberia to Madrid. The priest is the third human to receive the unapproved treatment, which is a cocktail of three monoclonal antibodies that is manufactured using tobacco plants by Kentucky Bioprocessing.
US FDA spokeswoman Stephanie Yao told BioPharma-Reporter.com the agency wasn’t involved in the shipment of the treatment to Africa, though FDA “has procedures in place to permit, in appropriate circumstances, emergency use in individual patients under an emergency IND [investigational new drug]. In other cases, exports of investigational drugs may be permitted without an IND as long as they meet the export requirements under the law,” she said.
Developing Treatments
ZMapp seems to be the unapproved antibody cocktail of choice so far, however, several other companies are ramping up the development of their Ebola treatments as the WHO convened a special committee meeting on Monday to discuss whether it’s ethical to use an unapproved treatment with unknown side effects.
None of the developmental treatments are likely to be ready until 2015, although the US FDA recently modified a hold placed on a Phase I clinical trial for Tekmira Pharmaceuticals’ anti-Ebola virus RNAi therapeutic, known as TKM-Ebola. The modified hold allows the company to potentially use the treatment on individuals infected with the virus, though the company has yet to use its treatment on any patients.
TKM-Ebola is being developed under a $140m contract with the US Department of Defense's Medical Countermeasure Systems BioDefense Therapeutics Joint Product Management Office and early preclinical studies demonstrated 100% protection in non-human primates from an otherwise lethal dose of the virus.
Sarepta Therapeutics has also been working on an RNAi therapeutic to treat Ebola since 2010 with the Department of Defense. The company claims it has up to two dozen courses of treatment, though it also hasn’t received any requests to use the medication, according to the Boston Globe.
GlaxoSmithKline, meanwhile, is developing an Ebola vaccine, which it hopes to be ready next year, and is slated to undergo Phase I testing soon, the company said.
But regardless of how many treatments are in companies’ pipelines, and even if African countries begin requesting unapproved treatments, there does not seem to be any company that can ramp up production and manufacturing quickly enough to meet the demands of the epidemic. However, Texas A&M has a facility that could help in ramping up production.
Gerald Parker, VP for public health preparedness and response at Texas A&M Health Science Center and principal investigator of the Texas A&M Center for Innovation in Advanced Development and Manufacturing, told us: "The Texas A&M Center for Innovation in Advanced Development and Manufacturing is one such center that would have the capability to scale up development and manufacturing efforts on vaccines and some therapeutics for the Ebola virus. The CIADM would need to coordinate and collaborate with any potential company, university, and/or researcher with an Ebola vaccine candidate to determine the technology readiness level of their vaccine candidate and specific needs for accelerated advanced development. The CIADM does have the capability to provide development and manufacturing core services for diverse vaccine platform technologies using flexible and adaptable manufacturing capabilities. The types of vaccines include live virus vaccines, inactivated viral vaccines, virus like particle vaccines and recombinant vaccines."