VENTURES AFRICA – The interest in and demand for experimental Ebola drugs and vaccines has intensified as the current epidemic spirals out of control in Guinea, Liberia, and Sierra Leone. The WHO approved the use of experimental treatments in early August of 2014. Altor BioScience, a pharmaceutical company based in the United States has told Ventures Africa that its drug ALT-836, which has been tested in humans, can significantly aid in the treatment of Ebola.
Credit: Leopoldo Martin R.
Ventures Africa spoke with Dr. Warren Marcus, a research and development scientist for Altor BioScience to get more information about ALT-836 and how this potentially game changing treatment can be used to combat the deadly Ebola virus.
Ventures Africa (VA): What is ALT-836?
Dr. Warren Marcus (WM): ALT-836 is a novel, high-affinity, chimeric anti-tissue factor monoclonal antibody that binds to human tissue factor (TF) or the TF-Factor VIIa (FVIIa)
complex preventing binding and activation of Factor X (FX) and Factor IX (FIX) to inhibit thrombin generation. But more generally, it blocks TF [tissue factor], which is a protein that is implicated in many different disease states. Research in a non-human primate model (rhesus macaques) [monkeys] demonstrated that blocking TF significantly increased the survival of those injected with a lethal dose of the Ebola virus. Therefore, we are confident that ALT-836 would likely do the same in humans.
VA: How is it administered?
WM: ALT-836 is administered via intravenous (IV) injection.
VA: Has it been tested in humans before and what were the results?
WM: Yes. ALT-836 has been used in phase 1 and 2 human clinical trials here in the United Stated in diseases that range from Coronary Artery Disease to Acute Lung Injury and Acute Respiratory Distress Syndrome to solid tumors (pancreatic cancer, non-small cell lung cancer, and soft tissue sarcoma). These are seemingly unrelated diseases, but the fact of the matter is that they are all characterized by an overexpression of TF. This goes to underscore my point before that TF is implicated in a plethora of diseases, and with evidence of it playing a major role in the pathogenicity of Ebola, we feel confident that ALT-836 would work in this indication as well.
To date, we have tested ALT-836 in 142 patients and the safety has been confirmed, along with strong evidence of efficacy. Because of all of this testing, we know the dose level and frequency that we should use, which gives us a distinct advantage over the other experimental drugs out there that have not been tested in humans.
VA: How readily available is the drug
WM: We have vials in-house that are available for shipment as soon as we have U.S. FDA clearance that we can do so and also work out the logistics of who to send the shipment to. To be clear though, unfortunately we do not have enough of a supply to treat everyone that has the virus – not even a majority of those that are infected.
VA: What are the obstacles for getting the drug deployed for use in affected West African Countries and how quickly can it be deployed?
WM: The only obstacle, as far as I can tell, is authority from the FDA. Once that is given, it would simply be a matter of shipping the vials in a temperature-controlled chamber (which we have) to the proper authorities in West Africa for distribution.
VA: Can you tell us a bit more about Altor BioScience?
WM: Altor BioScience Corporation is a small, private biopharmaceutical company located in the state of Florida in the U.S. Our goal is to develop treatments against cancer and infectious diseases. To that end, we have 3 lead products that have all reached the point of human clinical trials: ALT-801, ALT-803, and ALT-836. The majority of indications that we have ongoing clinical trials are cancer indications, but we will be looking to enter the infectious disease area within the next few years.
VA: What are the ethical issues that arise from using an untested drug?
WM: As I mentioned above, ALT-836 does not fall into the category of “untested drug” like the treatment options currently being discussed now. We have used our drug in well over 100 human patients and the safety profile is well-known. With that in mind, understanding the mechanism of action of the drug, and understanding the pathogenicity of Ebola, we feel confident that this drug would be safe, efficacious, and the morally correct way to move forward to treating those infected with the Ebola virus.
If ALT-836 can be made available to health workers and other extremely vulnerable populations in West African countries affected by Ebola it might change the course of the epidemic. At the last count, the Ebola outbreak has killed 1350 persons and infected a total of 2473 across the four west African countries of Guinea, Sierra Leone, Liberia, and Nigeria.