News out for CVM:
New H1N1 Treatment Could See Fast Approval From FDA
Tuesday September 22, 2009 12:25:55 EDT
Sep 22, 2009 (BAYSTREET NEWSWIRE via COMTEX News Network) --
According to a published report in Tuesday's New York Times, the World Health Organization has warned that they are facing possibly severe shortages of H1N1 vaccine. The organization and some health experts have been calling for the use of adjuvants to stretch the vaccine supply, but debate as to the potency and safety of these measures is still the focus of discussions.
It is widely reported that many Americans are afraid to take H1N1 vaccinations- which may require up to two shots for younger people. That has hospital officials accross the country worried since already emergency rooms and hospitals have been taxed all summer with overflowing demand for their services by patients suffering form H1N1 flu symptoms. The medical establishment has seen many more cases than usual during the summer months in North America and as winter prepares to hit the continent, many cities are hiring experts to help them deal with emergency plans for the pandemic.
Still, if the H1N1 pandemic behaves in a manner similar to the 1957 outbreak of H2N2 influenza then "closing schools, stopping large gatherings and other such measures are unlikely to do much," a team of public health experts told Reuters.
"Efforts to mitigate it were futile," Brooke Courtney, a researcher with the Center for Biosecurity at the University of Pittsburgh Medical Center told the wire service. "In 1957 it was decided pretty early on that efforts to quarantine or isolate people would not be effective," Courtney said.
Despite warnings from public health researchers, the Obama administration is moving full-speed ahead. And with some vaccine delivery target dates already missed, CDC spokeswoman Christine Pearson told the media, "It's important to public health to move forward with the regulations. We need to update our quarantine regulations, and this final rule is an important step."
One company has been quietly working on a treatment that may help the hundreds of thousands who will find themselves in intensive care units across the country- an actual treatment for those already inficeted with the H1N1 virus.
Scientists at Cel-Sci Corporation, a publicly traded company based in Vienna, VA, have come up with a novel approach that causes an immune response form the body unlike any of the ones previously developed by pharmaceutical companies and vaccine makers. The treatment received the attention of government officials in the U.S. and the FDA gave the group an unusually swift approval to conduct clinical trials of its drug candidate. The company has begun testing its effect on white blood cells of patients who are hospitalized. Given the fact that there are no other treatments for H1N1 and that this is an unmet medical need, experts in biotechnology believe that the company could also be set for a faster approval as well.
The company developed the heteroconjugate technology referred to as LEAPS (Ligand Epitope Antigen Presentation System), which is intended to selectively stimulate the human immune system to more effectively fight bacterial, viral and parasitic infections as well as autoimmune, allergies, transplantation rejection and cancer, when it cannot do so on its own.
Details about the workings of the drug have been hard to find, but medical experts say that the fact that the treatment has caught the attention of the FDA and CDC, speaks volumes about it's efficacy.
Already after extensive discussions with the FDA, Cel-Sci said that as it is already making preparations for a next-stage trial and putting together a requested follow-up regulatory filings with extensive additional data for the FDA.
The company said that it anticipates the full cooperation and support of the agency moving forward.
"Cel-Sci recognizes the importance of not only developing, but extensively testing an intervention that has the potential to treat pandemic flu," Cel-Sci CEO Geert Kersten told the Washington Business Journal, "Cel-Sci expects to work closely with the FDA and experts in the field in developing the necessary data and appropriate protocols to ensure that we rigorously meet the FDA regulatory requirements."
AI
