Clinical Trials: Ebola Hemorrhagic Fever

1. LeafBio, Inc.

2. Tekmira Pharmaceuticals Corporation

3. Chimerix, Inc.

4. GlaxoSmithKline

5. BioCryst Pharmaceuticals

6. Toyama Chemical Co. Ltd.

7. Sarepta Therapeutics, Inc.

8. NewLink Genetics

9. Hemispherx Biopharma, Inc.

10. NanoViricides Inc.

11. Fab'entech

12. Inovio Pharmaceuticals

13. Profectus Biosciences

14. Crucell

15. Bavarian Nordic

16. Sihuan Pharmaceutical

17. Immunovaccine Inc.

18. Protein Sciences Corporation

October 20, 2014(Updated: October 29, 12:35PM PT)By Mark Terry and Riley McDermid , BioSpace.com Breaking News StaffEveryone is undoubtedly aware of the Ebola crisis in West Africa that started in Guinea in December of 2013 and has since spread to Liberia, Sierra Leone, Nigeria and Senegal. Most recently, cases have been treated in the U.S., Norway, Germany, England and Spain.Though there are currently no effective treatments for Ebola and no vaccine, there have been several experimental treatments, such as's ZMapp and's TKM-Ebola, being used on humans under crisis conditions.Here's BioSpace's guide to who's working on therapeutics or vaccines for Ebola and how those pipelines are progressing.Companies that are not included in the list below but are also developing Ebola treatments are encouraged to contact BioSpace . We want to ensure the list contains the most updated information to help aid ongoing research for an approved cure.(Updated: October 29, 12:35PM PT)Headquartered in San Diego, California, LeafBio is the commercial arm of Mapp Biopharmaceuticals , which was founded in 2003 to develop compounds for the prevention and treatment of infectious diseases. The company’s Ebola drug,, is a combination of antibodies identified in January 2014 that showed efficacy in a monkey model of Ebola conducted by the(PHAC). ZMapp was given to seven people infected with Ebola, including two American aid workers. There was only enough of the drug to treat seven patients, and two of them died.In news announced in late October, U.S. health officials have asked three advanced laboratories to submit plans for the ramped-up production of ZMapp. Once proposals are submitted on Nov. 10, the(BARDA) will select which facilities work best for producing the most ZMapp the quickest. Tekmira Pharmaceuticals is headquartered in Burnaby, British Columbia and focuses on RNA interference (RNAi) therapeutics. In 2010, the company published several studies that showed the company’s LNP technology was effective in protecting non-human primates from Ebola.Funding was in part by the U.S.'s (DoD)(JPM-TMT) Office.They then inked a $140-million contract with the DoD to continue their RNAi therapeutic for the treatment of Ebola infection. The FDA gave the company Fast Track designation in March 2014 for TKM-Ebola, the anti-Ebola viral RNAi therapeutic. The work is being conducted under contract with the U.S. DoD's BioDefense Therapeutics (BD Tx) was authorized by the U.S. FDA on September 22 to be given as an experimental drug in an "expanded access" program to people with confirmed or suspected Ebola virus infections. Chimerix , located in Durham, North Carolina, focuses on antiviral medications. Specifically a clinical-stage nucleotide analog lipid-conjugate,. It is notable that the first U.S. Ebola patient,, who died on October 8 from Ebola atin Dallas, was treated with brincidofovir after the FDA approved its use on an emergency basis.Brincidofovir has shown positive effects in broad-spectrum in vitro activity against all five families of DNA viruses that affect humans, including cytomegalovirus (CMV), adenovirus (AdV), BK virus and herpes simplex viruses.Most recently, Chimerix was cleared to start Phase 2 Ebola clincial trials on October 16 . The FDA authorized a Phase 2 protocol for Brincidofovir to begin immediately. Brincidofovir tablets are available for immediate use in clinical trials.On August 28, 2014, GlaxoSmithKline announced it would begin human testing of an investigational vaccine to prevent Ebola virus disease. The Phase 1 clinical trial, called, will be led by principal investigator, D.O., chief of the NIAID's (VRC) clinical trials program, and will be conducted among 20 healthy adults ages 18 to 50 years.The vaccine was co-developed with the NIAID. The vaccine candidate was designed by, chief of the Biodefense Research Section in NIAID's VRC, collaborating with researchers at the VRC and USAMRIID, as well as, a Swiss-Italian biotech company acquired by GSK in 2013.Headquartered in Research Triangle Park, North Carolina, on September 18, 2014 BioCryst Pharmaceuticals announced that the NIAID had exercised options up to $2.0 million to increase funding to the development contract for the compound. The drug is under development for the treatment of hemorrhagic fever viruses, which includes Ebola virus and Marburg virus. This is an extension of a five-year contract that began in September 2013.A unit of Toyama Chemical has a potential Ebola treatment called. The drug, () was originally designed for the treatment of avian flu. The company’s U.S. partner is MediVector . Bloomberg reported in early August that MediVector, located in Boston, was in talks with the FDA to submit an application for use in humans for Ebola. The primary advantage is that the drug has been extensively tested as an antiviral in humans for influenza. It is currently in a final-stage trial for influenza in the U.S.Headquartered in Cambridge, Massachusetts., Sarepta Therapeutics develops RNA-based therapeutics. The company has, a modified RNA molecule that is directed against one of the three Ebola virus genes that are also targeted by's. The drug, however, uses a different mechanism to block the production of the viral proteins.It has shown to be effective in non-human primates against the Ebola virus and the company has been conducting Phase 1 safety trials with AVI-7537 alone and with another Ebola-directed PMOplus molecule, which in combination is called. In August 2014, the company’s president and CEO, indicated they had trial-ready doses of the drug ready to be deployed and shipped if needed.is a co-signee on the two patents with Sarepta.Established in 1999 and based in Ames, Iowa, NewLink Genetics focuses on vaccines and therapeutics that stimulate the immune system. On September 4, 2014, the FDA gave the company permission to begin a Phase 1 clinical trial with their Ebola vaccine candidate,).Initially developed by PHAC, and under an exclusive license with, the vaccine has shown promise in both pre- and post-exposure vaccination of non-human primates exposed to lethal doses of the Ebola virus. The company is working with the DoD's(DTRA) and the(WRAIR).In more recent news, the Government of Canada announced that it will ship 800 vials of the experimental Ebola vaccine to the(WHO) in Geneva, beginning with its first shipment on Monday, October 20, 2014.Headquartered in Philadelphia, Hemispherx Biopharma focuses on treating and preventing chronic viral and immune-based disorders. The company's flagship products includeand an experimental immunotherapeutic dubbed. On September 29, 2014, the company announced widening its research collaborations to develop therapeutic cocktails against Ebola virus.Ampligen and Alferon are presently in the lab testing phase in eight labs in the U.S., Western Europe, and Canada. It is in the discussion phase in West Africa with various government officials.Located in West Haven, Connecticut, NanoViricides develops nanotechnology-based biomimetic anti-viral medications (which the company calls nanoviricides). The company has a number of products in its pipeline focused on influenza (FluCide), viral eye diseases (EKC-Cide- I), HIV/AIDS (HivCide-I) and Rabies (RabiCide-I). In addition, it has Accurate-Drug-In-Field (ADIF) Technology for Bio-Defense programs. On October 1, 2014, the company announced that it had started synthesizing its second-generation drug candidates for the treatment of Ebola.Founded in 2009 in Lyon, France, Fab'entech focuses on the development and commercialization of passive immunotherapeutic compounds based on specific polyclonal immunoglobulins in emerging infectious diseases. It has ongoing work for Ebola, SARS, MERS-CoV, Lassa, Machupo, Junin and West Nile Virus with a project called EMER-IT. The(EMA) announced on September 30, 2014 that it was evaluating several untested drugs for Ebola for trials, including Fab'entech's Ebola product,. Fab'entech is conducting clinical trial feasibility for its Ebola candidate.In May 2013, Inovio Pharmaceuticals announced a successful preclinical study of its DNA vaccine,, against Ebola and Marburg viruses. In September 2014, Inovio announced it was moving the vaccine into a Phase 1 clinical trial with, a DNA vaccine manufacturer in which Inovio holds a minority interest. The companies plan to collaborate on co-developing the vaccine through the Phase 1 trial, which is expected to start in the first half of 2015. Located in Plymouth Meeting, Pennsylvania, Inovio focuses on a synthetic immune therapy technology platform (a new form of vaccines). Profectus Biosciences is developing vaccines for pre- and post-exposure protection against the hemorrhagic disease caused by Ebola and Marburg viruses. Multiple studies conducted by a team from the NIAID, CDC, FDA, and DoD have shown that a single dose of the Profectusvectored Ebola and Marburg vaccines provides 100 percent protection of non-human primates against challenge with 1,000 times the lethal dose of both Ebola and Marburg viruses.Profectus announced on October 22 that it received an $8.6 million HHS contract to accelerate Ebola Vaccine into human clinical studies. The company also received a three-year $8.5M grant from theto fund studies directed at early steps of the ongoing development of a vaccine to provide pre- and post-exposure protection against exposure with all major strains of Ebola and Marburg viruses.A subsidiary of'sunit, Crucell is currently developing a multivalent filovirus vaccine against Ebola and Marburg in collaboration with NIAID's VRC. Crucell's Ebola vaccine entered Phase I clinical trials in Q3 2006. Two groups of 16 volunteers were enrolled and vaccinated. The study showed safety and immunogenicity at the doses evaluated.In October 2008, Crucell secured an NIH/NIAID award to advance the development of Ebola and Marburg vaccines, with the ultimate aim of developing a multivalent filovirus vaccine. Thus far, Crucell’s research has been shown to completely protect monkeys against the virus with a single dose of the vaccine.In September 2014, Johnson & Johnson announced that it will be working with the NIH to fast-track the development of a new combination vaccine regimen. It is composed of two vaccine components, which are based on MVA-BN technology fromand AdVac technology from. The initiation of a clinical trial in humans may take place as early as 2015. Bavarian Nordic is concurrently in preclinical testing on a multivalent vaccine that protects against the two major strains of Ebola (Zaire and Sudan) as well as Marburg. The company is also in discussions with the NIAID to accelerate the development of this multivalent vaccine into a clinical Phase 1 study in the next 12 months.A recent study, conducted under NIAID’s vaccine preclinical services program, demonstrated proof of concept for a prime-boost regimen of two vaccines based on Bavarian Nordic's MVA-BN technology and's AdVac technology respectively. Results from the study show complete protection against the highly virulent Ebola Zaire species with the initiation of a trial in humans, anticipated in 2015.Originally funded by the Chinese military, Sihuan Pharmaceutical has partnered with the Chinese Research(AMMS) to help push an emergency antiviral military drug calledthrough the approval process in China. Sihuan is China's third largest prescription drugmaker and was spun off from the military as a standalone unit in 2001.Last week, Sihuan announced it was preparing for clinical trials in Africa and could test the drug on African Ebola patients. The company supplied several thousand doses of its Ebola drug JK-05 to the region. Although proven effective in preclinical trials, JK-05 has not been used on humans. Immunovaccine 's vaccinewas developed in collaboration with the NIH/NIAID. NIH/NIAID provided the antigen and Immunovaccine formulated it in its DepoVax technology. Immunovaccine's DepoVax technology tested well in an Ebola virus challenge study performed by the NIH/NIAID late this summer (August). In the study using cynomolgus monkeys, which were particularly sensitive to the Ebola virus, all vaccinated subjects survived exposure to the lethal dose. All unvaccinated control animals succumbed to the disease. Based on this efficacy, Immunovaccine is working with the NIH/NIAID to ramp up studies of DPX-Ebola for 2015. New data are expected to support advancing DPX-Ebola into human studies.Based in Meriden, Conn., Protein Sciences Corporation is working on an Ebola vaccine using recombinant technology made using the same BEVS platform that is used to manufacture the licensed influenza vaccine Flublok. Protein Sciences plans to deliver samples to the National Institutes of Health for testing in December. If the vaccine proves itself in tests, the National Institutes of Health would fund further development and production.