Yahoo is on the road in the heartland. See MM's tweets. Roll out the barrel, we'll have a barrel of funds.
As Ardea describes it, in their Phase III trial
Allopurinol is the standard of care for the treatment of gout. Nevertheless, most patients treated with allopurinol do not achieve the recommended sUA target of
Naval Medical Research and Development News, Vol. V, Issue 4, April 2013
Capt. John W. Sanders invited NMRC science directors to informally discuss their research with Rear Admiral Brian P. Monahan, the attending physician for the U.S. Congress and U.S. Supreme Court. See first item mentioned
"Infectious diseases researchers are involved with vaccine trials against dengue, Campylobacter, Shigella,
E. coli and malaria."
Oh the facebook girls are social
And they “like” you every day
And those google guys
With their glassy eyes
Take all your privacy away
But the Yahoo girls
Are the real pearls
With the site where you want to stay
I wish they all could be Stanford girls
I wish they all could be Stanford girls
I wish they all could be Stanford girls
Cause they make Yahoo pay.
NIH/DHHS actively seeking adjuvants-complete RFP May 10, 2013
Added: Apr 25, 2013 4:22 pm
The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. Through this solicitation, the NIAID Division of Allergy, Immunology and Transplantation plans to support the early stage discovery and initial characterization of novel adjuvant candidates. Thus, research solicited under this acquisition will contribute to the pipeline of new adjuvant leads that either (a) exploit the natural capacity of the innate immune system to initiate and sustain effective T and B cell responses and to induce long term immune memory or (b) act directly on lymphocytes to enhance their response to pathogen-derived antigens.
May 10 FBO pre-solicitation
The Department of Health and Human Services (HHS) intends to issue a Request for Proposal (RFP) for the acquisition of ancillary materials (needles, syringes, and combination units, isopropyl alcohol prep pads) from medical/surgical device manufacturers to meet the vaccine administration needs of the American public during a pandemic influenza event. To ensure coverage, manufacturers are expected to acquire, maintain and rotate inventories of integrated needle and syringe units of various types for pandemic preparedness. The management of these materials will be coordinated and integrated by HHS/ASPR/BARDA to provide long-term solutions that address and satisfy the vaccine administration requirements during pandemic influenza events and account for recent technology advances in vaccine manufacturing where the ability to produce influenza vaccines may outstrip the capability of medical/surgical manufacturers to maintain pace with sufficient needle/syringe units.
and see for example, CDC May 10 update
CDC is working on developing candidate vaccine viruses (CVVs) from two different H7N9 isolates (Shanghai/2 and Anhui/1). A CVV is a flu virus that CDC (or one of the other WHO Collaborating Centers) selects and prepares for use by vaccine manufacturers to make a flu vaccine. These CVVs could be used to manufacture vaccine if one is needed. Candidate vaccine viruses are typically chosen based on their similarity to flu viruses spreading and causing illness in people as well as their ability to grow easily in chicken eggs, which is the primary method of manufacturing influenza vaccine. Without a high-yield candidate vaccine virus, it can be very difficult to manufacture vaccine to protect against a new influenza virus.
Once a vaccine manufacturer receives a candidate vaccine virus, manufacturers then create what is known as a "seed strain." The seed strain is adapted by each manufacturer to make the virus grow better using their technology and production systems. Once the seed strain is prepared, the vaccine manufacturer uses it to grow large quantities of virus for producing flu vaccine.
On May 1, 2013, CDC offered to begin shipping potential candidate vaccine viruses to qualified laboratories with biosafety-level 3 facilities that wanted to begin working on creating their own seed virus early. These are candidate vaccine viruses that still require some in vitro and in vivo studies to be completed to meet full regulatory and biosafety requirements. Other WHO partners have potential candidate vaccine viruses as well. Neither the World Health Organization or the U.S. Food and Drug Administration have made any recommendation about which H7N9 potential candidate vaccine virus is recommended for use in the manufacture of H7N9 vaccine.
It’s important to note that influenza vaccine production is complex and can be unpredictable and has many critical and time-sensitive steps; delay at any point during these steps can result in delays in the availability of influenza vaccine. However, it usually takes about six months to produce large quantities of influenza vaccine.
Because HAE is a repeated syndrome, trials of a treatment may bring quick results. This view is reinforced by the earnings call transcript below that indicate results may be updated this summer and then a move to high attack rate patients.
Moving onto our HAE program. We began dosing healthy volunteers in the single-ascending dose portion of our Phase I trial of BCX4161 in late March and the trial is proceeding according to plan. 4161 is the first oral kallikrein inhibitor to advance in the human studies specifically as a potential treatment for this orphan disease.
The primary goals of our Phase I program are to demonstrate oral bioavailability and safety in humans. We need to show consistent PK with adequate exposure levels that suppress plasma kallikrein. Following satisfactory progress in the SAD portion of the trial, we plan to move to the multiple ascending dose phase, complete the trial and report outcomes soon thereafter. You can expect us to update you regarding the results this summer. If successful, we will start a trial later in 2013 in HAE patients who have high attack rates. We're working with top experts in the field on this study with the main objective of estimating the treatment effect of 4161.
Pathway to NDA for peramivir, further development once formal announcement from govt after in process contract review. hAE results this summer, phase 2 if successful. Have enough cash for another year at this point. Good enough for me, more peramivir news to come this year.
Someone posted there would need to be phase 1/2 trials with Vaxfectin with another substance to ensure there were no adverse events AEs. duh. Remember this Navy dengue trial with 3 different levels no-Vx, med and more Vx is on going with human subjects right now and nearing completion, so the phase 1 trial issue is complete, just waiting for results
FOR IMMEDIATE RELEASE
Monday, July 13, 2009 Contact: HHS Press Office
HHS Purchases Additional H1N1 Vaccine Ingredients
HHS Secretary Kathleen Sebelius announced today that the department will commit $884 million to purchase additional supplies of two key ingredients for potential H1N1 vaccine to further prepare the nation for a potential resurgence of the 2009 H1N1 virus.
“We recognize that preparedness is shared responsibility between federal, tribal, state, local governments, private organizations and individuals. We are doing our part to be as prepared as possible for the impact that this infectious disease could have on our country,” Secretary Sebelius said. “Vaccines may serve an important role in that preparedness. The action we are taking today will provide flexibility in a future immunization program, if a program is recommended.”
The funds will be used to place additional orders for bulk H1N1 antigen and adjuvant on existing contracts with Sanofi Pasteur, MedImmune, GlaxoSmithKline and Novartis. The vaccine ingredients will become a part of the pandemic stockpile, for use if a vaccination campaign is necessary.
Lord Carlisle of Liberal Democrats supports Communications Data Bill of Home Secretary giving security forces access to website visits and social media of all internet users - Daily Telegraph
See tweet of
Therese Hansen 1h
I really should wait to share this, because it isn't ready, but this is a sneak peek into what we are making next
Patent Issued for Adjuvant Compositions and Methods for Enhancing Immune Responses to Polynucleotide-Based Vaccines
The patent's assignee for patent number 8415317 is Vical Incorporated (San Diego, CA).
News editors obtained the following quote from the background information supplied by the inventors: "Field of the Invention
"The present invention relates generally to adjuvants, immunogenic compositions, and methods useful for polynucleotide-based vaccination. The present invention provides compositions and methods useful for enhancing immune response, especially the humoral immune response of vertebrates to polynucleotide-based vaccines.
H7N9 Update; CDC Pandemic Preparedness Activities Progress
April 26, 2013 – The number of human infections with avian influenza A (H7N9) in China has risen to 109; with 23 deaths.* There are still no reports of H7N9 in the United States. While there is no evidence of sustained human-to-human spread of this virus, CDC is taking routine pandemic preparedness measures to prepare for that possibility.
Testing for Antiviral Susceptibility
It’s important to note that influenza viruses can be, or can become, resistant to influenza antiviral drugs, and if this happens, these medications may not be fully effective. As new H7N9 virus isolates are received, CDC will conduct testing to determine their susceptibility to existing antiviral drugs. Now, CDC recommends oseltamivir/Tamiflu® and zanamivir/Relenza® for treatment of patients with suspected or confirmed H7N9.
All work with live H7N9 virus is being done in Biosafety Level-3 (BSL-3) enhanced containment. A BSL-3 facility with specific enhancements includes primary (biological safety cabinets, bio-isolator chambers, personal protective equipment) and secondary (facility construction, HEPA filtration treatment of exhaust air barriers to protect laboratory workers and the public from accidental exposure.
Good thing about HAE is it recurs over and over, so if a therapy works, results will show upnquickly.
BCX4161 is a slow-tight-binding inhibitor that forms stable enzyme/ inhibitor complexes with plasma kallikrein in 2 steps
BCX4161 inhibits plasma kallikrein at drug concentrations 2 orders of magnitude lower than those required to impact known off-target effects
Sent from my iPad
BCX4161 median EC50 for plasma kallikrein is 5.9 nM in a sample of 51 normal volunteers
BCX4161 is a potent and specific inhibitor of plasma kallikrein with potential to be the first targeted oral prophylaxis treatment for HAE
The main goals of the Phase 1 clinical trial are to assess safety, characterize plasma drug levels, and estimate the extent of kallikrein inhibition achieved after oral dosing of BCX4161. This clinical trial is being conducted at Quotient Clinical in the United Kingdom utilizing an integrated Translational PharmaceuticsTM platform and the results are expected to be announced in 2013
Preparedness measure....what else would be a preparedness measure that a prudent public health agency would want to have on hand? Bueller? Bueller? Hemmer? Hemmer?
Emergency Use Authorization (EUA):
On April 22, 2013, the FDA issued an Emergency Use Authorization (EUA) for the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel-Influenza A/H7 (Eurasian Lineage) Assay. More information is available from the FDA website. Note that issuance of this EUA does NOT indicate that an actual public health emergency exists in the United States. Distribution of diagnostic test kits domestically is a preparedness measure.