NEW YORK --(BUSINESS WIRE)-- SIGA Technologies, Inc a company specializing in the development of pharmaceutical agents to combat bio-warfare pathogens, announced today that it has begun enrolling the second and final cohort of healthy subjects for the Phase III clinical study for its lead drug candidate, TPOXX (tecovirimat), for the treatment of orthopoxvirus. This Phase III study, which is wholly funded the by the Biomedical Advanced Research and Development Authority (BARDA) will be conducted at eleven approved investigative sites with a total of approximately 360 subjects.
The initial Phase III lead cohort of 40 subjects in this trial has already completed participation without any reports of serious adverse events.
Screening of subjects for the second Phase III cohort initiated on April 11, 2016 , and the first subject was enrolled and dosed on April 18, 2016 . Since tecovirimat is being developed under the FDA "Animal Rule," there are no efficacy endpoints in this clinical trial. This study will generate safety and pharmacokinetic data in support of the prescribing information that will be part of the New Drug Application (NDA) filing.
PR released on digitaljournalDOTcom
Feb 24, 2016 14:00 UTC
FDA Concurs on Clinical Dose for SIGA’s Tecovirimat Antiviral
NEW YORK--(Business Wire)--SIGA Technologies, Inc. (SIGA), a company specializing in the commercialization of solutions for serious unmet medical needs and bio-defense, today announced the receipt of FDA concurrence on a dose for continuing the pivotal clinical human safety study for tecovirimat (also known as TPOXX and ST-246), an antiviral pharmaceutical to treat orthopoxvirus-related diseases, including smallpox. Smallpox has been determined to be a material threat to US security and is classified by CDC as a Class A pathogen.
The concurrence on dosage by the FDA provides SIGA with the guidance it needs to complete its Phase 3 expanded safety trial in human subjects for the oral formulation of tecovirimat.
“We are pleased to receive FDA concurrence on dosage for our clinical safety studies and look forward to the future development and distribution of this critical antiviral,” said Dr. Eric Rose, SIGA’s Chief Executive Officer.
Monkeypox outbreak: Dozens of cases reported in Bas-Uele District, DRC
Posted by Robert Herriman on February 10, 2016
Health officials in Bas-Uele District, Orientale Province of northern Democratic Republic of the Congo (DRC) are reporting a monkeypox outbreak, which has affected more than 50 and killed two, according to a Radio Okapi report today (computer translated).
Dr Innocent Akonda said that 51 cases were reported during the first week of February, with cases reported in the Bombongolo health area, Aboso and other health areas. With the new cases, the health zone recorded 195 cases including 8 deaths, said Akonda.
The battle against the outbreak is especially problematic due to lack of qualified medical personnel, equipment, collection kits and lack of sanitation. “We only have one qualified nurse in Bombongolo. When he moves, it is the waiters who care for the sick. Healers also monopolize the sick to offer them miracles-healings, “added Dr Innocent Akonda.
Monkeypox is a relatively rare virus found primarily in central and western Africa. The disease is caused by Monkeypox virus. It is closely related to the smallpox virus (variola), the virus used in the smallpox vaccine (vaccinia), and the cowpox virus.
Infection with monkeypox is not as serious as its cousin, smallpox; however, human deaths have been attributed to monkeypox.
This was a rabbit-pox study. Try to find the results of their nonhuman primate testing... I'll give you a hint, Chimerix did their best to bury these results, probably with the monkeys.
bobby. If you go to oxitec's website you can see everything you are questioning regarding the study they want to have in the keys. Here are excerpts from the news section of their site:
"Oxitec in Florida features on Channel 4 News"
"Oxitec’s pioneering science has once again attracted coverage from a major news service.
Channel 4 News produced a thoughtful piece on Oxitec’s science and our work in the Florida Keys. View the story and video here."
"WHO @WHO 52m52 minutes ago
WHO Director-General Dr Margaret Chan: #ZikaVirus & #microcephaly situation is a Public Health Emergency of Intl Concern #alert"
"WHO @WHO 42m42 minutes ago
Dr Heymann emphasized vector control, surveillance, R&D for vaccines & other goods needed to control #Zika if link w/#microcephaly is proven"
"WHO @WHO 48m48 minutes ago
Dr Chan: [A coord intl response is also needed] to intensify the control of mosquito, to expedite the dvlpmnt of diagnostic tests, vax #Zika"
"WHO @WHO 49m49 minutes ago
Dr Chan: [At present, the most important #Zika protective measures are] the prevention of mosq bites in at-risk indivs, esp pregnant women"
now from the BBC:
"Zika-linked condition: WHO declares global emergency
By Michelle Roberts
Health editor, BBC News online
A cluster of microcephaly linked to the Zika virus in Latin America poses a global public health emergency requiring a united response, says the World Health Organization.
Experts are worried that the virus is spreading far and fast, with devastating consequences.
The infection has been linked to thousands of babies being born with underdeveloped brains.
The WHO alert puts Zika in the same category of concern as Ebola.
It means research and aid will be fast-tracked to tackle the infection.
WHO director general, Margaret Chan called Zika an "extraordinary event" that needed a coordinated response.
"I am now declaring that the recent cluster of microcephaly and other neurological abnormalities reported in Latin America following a similar cluster in French Polynesia in 2014 constitutes a public health emergency of international concern."
She said the priorities were to protect pregnant women and their babies from harm and to control the mosquitoes that are spreading the virus.
She advised pregnant women:
to consider delaying travel to areas affected by Zika
seek advice from their physician if they are living in areas affected by Zika, as well as protect themselves against mosquito bites by wearing repellent
Dr Chan justified declaring an emergency even amid uncertainties about the disease, saying now was not the time to wait.
The WHO faced heavy criticism for waiting too long to declare the Ebola outbreak a public emergency.
XON has already made the front page of the New York Times on the Zika outbreak. After the WHO makes their declaration, I expect much more coverage on that declaration, and the technologies positioned to address it.
Per the Jerusalem Post:
"Geneva - Independent experts to the World Health Organization began deliberating on Monday whether to declare a global emergency over the Zika virus, which has been linked to thousands of birth defects in Brazil.
The designation would fast-track international action and research priorities, following criticism of a hesitant response so far.
The United Nations agency said last week the Zika virus was "spreading explosively" and could infect as many as 4 million people in the Americas.
The WHO was criticized for reacting too slowly to the Ebola epidemic in West Africa which killed more than 10,000 people, and has promised to do better in future global health crises.
The 12 committee members, who are experts in epidemiology, public health and infectious diseases from the Americas, Europe, Asia and Africa, discussed the issue in a telephone conference. A news briefing will be held on Tuesday afternoon at the earliest, the WHO said."
Based on previous statements that Zika is "spreading explosively" and their history of underestimating Ebola, odds are the WHO will declare a global emergency over Zika. Such declarations require action. As there are no vaccines or antivirals available to treat the Virus, promising candidates like INO's vaccine will most likely be granted fast track status as well as grant funding through HHS/BARDA.
Outside of accelerating therapeutic/vaccine development, actions available to governments and organizations like the WHO, include those aimed at targeting the vectors by attacking breeding grounds and mosquitoes through conventional approaches like fogging, and emerging techniques like XON's GMM's and Wolbachia bacterium based approaches like those backed by the Gates Foundation.