Injectable drug seen as potential treatment for flu, both seasonal and avian

first_imgOct 2, 2006 (CIDRAP News) – Recent tests suggest that an antiviral drug given by intravenous (IV) or intramuscular (IM) injection could eventually serve as another weapon against influenza, according to results presented at a conference last week.In animal studies, peramivir improved survival in mice and ferrets infected with H5N1 avian flu, according to a news release from BioCryst Pharmaceuticals Inc., Birmingham, Ala., which is developing the drug. The results were presented Sep 30 at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Francisco.In addition, in phase 1 clinical studies, IV and IM doses of peramivir produced high blood levels of the drug in human volunteers without causing any adverse events, according to Dr. Charles E. Bugg, PhD, chairman and chief executive of BioCryst.The clinical studies “showed you can achieve high blood levels in humans safely,” Bugg told CIDRAP News in an interview today. The combination of those results with the animal studies is promising, he said.Peramivir is a neuraminidase inhibitor, like the licensed antivirals oseltamivir (Tamiflu), and zanamivir (Relenza). Oseltamivir is an oral drug, while zanamivir is inhaled as a powder. Many countries have stockpiled oseltamivir on the assumption that it will help if the H5N1 virus sparks a pandemic.BioCryst started developing peramivir in 1998 in partnership with Johnson and Johnson, Bugg said. Early studies showed the drug inhibited flu viruses effectively, but when taken orally, its bioavailability was very low, which prompted Johnson and Johnson to pull out of the program.Because injectable peramivir looked promising in animals, the program was resurrected with help from the National Institutes of Health about a year ago, Bugg said. He explained that the company is developing an IV formulation intended for hospital patients and an IM formulation for outpatients.In the animal studies, four groups of mice were infected with an H5N1 virus and then were treated with either a single IM injection of peramvir, five daily IM injections, oral oseltamivir for 5 days, or an IM placebo injection daily for 5 days, according to the news release. The single-injection group had a 70% survival rate and the five-injection group a 80% survival rate, compared with 36% for the placebo group and 70% for the oseltamivir group.In the ferret experiment, one group received a daily IM injection for 5 days, while a second group received an IM placebo daily for 5 days. Eighty-six percent of the treated group survived, versus 43% of the placebo group, according to the news release.Bugg said treatment was started an hour after the animals were infected with the virus. He said additional studies will involve longer time lapses between exposure and the start of treatment.Results of the clinical studies were presented by flu expert Frederick Hayden, MD, of the University of Virginia. Three groups of volunteers received different IV doses of peramivir, and a fourth group received increasing IM doses once a day for 3 days, the company release said. “Preliminary safety results indicate that in the four studies, all doses were well-tolerated with no adverse laboratory events or ECG findings reported,” the statement said.”I think peramivir looks very promising,” said Hayden, as quoted in a Sep 29 Bloomberg News report. “It’s proven to have very good activity in single doses.”In an interview, Hayden told Bloomberg that injecting peramivir into the bloodstream or into muscle can produce blood levels 100 times higher than those seen with oral oseltamivir, now considered the most promising treatment for H5N1 infection.Last January the Food and Drug Administration (FDA) gave injectable peramivir fast-track status for regulatory approval, according to BioCryst. But Bugg said it would take at least several more years to gain FDA approval.”We’ll do a clinical trial this flu season, and then two more next season,” he said. “We’re looking at several more years.” He said the company will be meeting with the FDA soon to review the program and may have a better idea of the timeline after that.Bugg said plans also call for testing the drug in human H5N1 patients at sites in Thailand and Vietnam and also to make it available in Turkey, which had human cases early this year.”We’ll be trying to collect data from H5N1-infected patients in Southeast Asia in collaboration with the World Health Organization,” he said. “We’ll be on the front line to capture H5N1 if it occurs. But realistically we won’t have enough [patients] for a meaningful statistical analysis.”In a Sep 29 Reuters report, Bugg said peramivir is easier to make than Tamiflu. One Swiss manufacturer can make 1 metric ton of the drug in a month, enough to treat an estimated 8 million people, he said.See also:Oct 2 BioCryst release on peramivirhttp://investor.shareholder.com/biocryst/releasedetail.cfm?ReleaseID=213054last_img read more

US pushes arms sales surge to Taiwan, needling China: Sources

first_imgTaiwan’s military is well-trained and well-equipped with mostly US-made hardware, but China has a huge numerical superiority and is adding advanced equipment of its own.The weapons packages from Lockheed Martin Co, Boeing and General Atomics are moving their way through the export process, three people familiar with the status of the deals on Capitol Hill said, and a notification to Congress is expected within weeks.One industry source said President Donald Trump was slated to be briefed on the packages this week by Secretary of State Mike Pompeo. Some of the deals had been requested by Taiwan more than a year ago, but are only now being moved through the approval process. A State Department spokesman declined comment.A senior US official, citing Chinese assertiveness in the Taiwan Strait, said: “There is no equilibrium today. It is out of balance. And I think that is dangerous.”Trump’s White House has made an effort to export weapons to US allies trying to bolster their defenses, decrease dependence on US troops while boosting US companies and jobs.As he fights for re-election on Nov. 3, Trump and Republican supporters have ramped up their rhetoric against Beijing and sought to portray Democratic opponent Joe Biden as soft on China.Other factors include Taiwan’s bigger defense budget, and the fear in Taiwan that if Trump loses, Biden would be less willing to sell the US’s most advanced weapons to them.Taiwan’s interest in US weapons and equipment is not new. The island is bolstering its defenses in the face of what it sees as increasingly threatening moves by Beijing, such as regular Chinese air force and naval exercises near Taiwan.The senior US official said Taiwan’s increased defense spending was a good step, but it had to do more.”Taiwan, frankly, needs to do more in order to ensure that they indigenously have an ability to deter Chinese aggression,” the official said.DealsDrones that can see over the horizon for surveillance and targeting, coupled with advanced missiles and coastal defenses that include smart mines and anti-submarine capabilities to impede a sea invasion, have been discussed at the highest levels to make Taiwan more difficult to attack, like a “porcupine”, according to industry and congressional sources.A Lockheed Martin-made High Mobility Artillery Rocket System (HIMARS), essentially a truck-based rocket launcher, is among the weapons Taiwan wants, people familiar with the negotiations said. Taiwan also seeks to buy sophisticated anti-tank missiles.In early August, Reuters reported that Washington is negotiating the sale of at least four of its large sophisticated aerial drones to Taiwan for what could be about $600 million.Also under discussion are land-based Boeing-made Harpoon anti-ship missiles to serve as a coastal defense against cruise missiles.Other systems include “underwater sea mines and other capabilities to deter amphibious landing, or immediate attack,” Taiwan’s de facto ambassador to United States said in July.  At the same time Taiwan’s desire to buy weapons increased after President Tsai Ing-wen was re-elected in January and has made strengthening Taiwan’s defenses a top priority.Taiwan is China’s most sensitive territorial issue. Beijing says it is a Chinese province, and has denounced the Trump administration’s support for the island.Washington has been eager to create a military counterbalance to Chinese forces, building on an effort known within the Pentagon as “Fortress Taiwan”, as Beijing’s military makes increasingly aggressive moves in the region.Taiwan’s Defense Ministry said the reported package was a “media assumption,” and that it handled weapons purchase talks and assessments in a low-key, confidential way, so could not offer public comment until there was a formal US notification of any sales to Congress. The United States plans to sell as many as seven major weapons systems, including mines, cruise missiles and drones to Taiwan, four people familiar with the discussions said, as the Trump administration ramps up pressure on China.Pursuing seven sales at once is a rare departure from years of precedent in which US military sales to the island were spaced out and carefully calibrated to minimize tensions with Beijing.But the Trump administration has become more aggressive with China in 2020 and the sales would land as relations between Beijing and Washington are at their lowest point in decades over accusations of spying, a lingering trade war and disputes about the spread of the novel coronavirus.center_img Topics :last_img read more