Finding a cure for any disease is a long process, but when it comes to a life-threatening disease like Ebola, drugmakers such as GlaxoSmithKline (GSK 1.06%) don't have the luxury of time.
The need to develop a cure to prevent or halt the spread of this potentially deadly disease has never been greater given the current outbreak in Africa and the need to treat patients across several continents. According to the World Health Organization, more than 5,600 people have died during the Ebola outbreak this year. Fortunately, help may be on the way -- GlaxoSmithKline's attempt to create an Ebola vaccine appears to have taken a big step forward this past month.
First, a bit of background
Ebola is undeniably a difficult-to-treat disease with a poor prognosis, but it's also a rare disease that has mostly affected developing regions.
Ebola is spread through through contact with an infected person's bodily fluids, either person-to-person or through contaminated items. Since there aren't any drugs approved to treat Ebola patients, most patient care is focused on treating the symptoms of the disease. In addition to that treatment, health officials undertake preventative measures to limit the chance of the disease spreading, including monitoring people who may have had contact with infected patients.
Unfortunately, palliative care and monitoring only goes so far toward containing the disease. Early symptoms of the disease resemble the flu and patients remain highly contagious for up to 21 days following the start of their symptoms. That makes it difficult to accurately diagnose patients and creates challenges to finding and sequestering people who may have been exposed to the virus, especially in highly populated cities. As a result, creating a vaccine that can either be used as a cure or to inoculate people against the Ebola virus remains the single biggest focus for healthcare participants working on stopping the disease.
Source: GlaxoSmithKline
Promising start
GlaxoSmithKline is working with the National Institutes of Health on its early stage Ebola vaccine, which has shown promise in pre-clinical trials and has now shown encouraging signs of being safe to use in humans.
Thanks to funding from the Wellcome Trust, Medical Research Council, and the U.K. government, GlaxoSmithKline is currently conducting a phase 1 trial of the vaccine in volunteers in the U.S. and United Kingdom. GlaxoSmithKline is also in the process of creating up to 10,000 doses of the vaccine for emergency use, such as for healthcare workers.
GlaxoSmithKline's vaccine contains genetic material from two Ebola strains, including the strain responsible for the current outbreak in West Africa. That genetic material does not include the virus, so it can't cause the disease in patients receiving it.
The phase 1 trial, which enrolled just 20 volunteers, began on September 2nd and will last 48 weeks. According to GlaxoSmithKline, early results are encouraging. All 20 participants received either a low or high dose of the vaccine and all 20 developed anti-Ebola antibodies within the first four weeks. Those on the higher dose developed more antibodies than those on the lower dose.
Ongoing effort
GlaxoSmithKline is one of a slate of companies working on Ebola vaccines. Other promising treatments in development include ZMapp from the privately held Mapp Pharmaceuticals and TKM-Ebola, which is under development by Tekmira Pharmaceuticals. ZMapp was used to treat Americans Dr. Kent Brantly and Nancy Writebol after they contracted Ebola helping patients in Africa, and in September, the U.S. and EU regulators approved the emergency use of Tekmira's drug. Another vaccine may also be coming from Merck (NYSE: MRK), which acquired global rights to NewLink's Ebola vaccine last week in exchange for $30 million up front, $20 million in milestone payments, and royalties on any eventual sales. Early stage trials of NewLink's vaccine in humans are already under way, and if those go well, late stage trials could begin in 2015. That may suggest that GlaxoSmithKline and Merck will be among the first to vie for full FDA approval of an Ebola vaccine.
