Announced some phase I data on May 16 for results in injected and non injected lesions, taking off May 24 before a May 29 presentation, another competitor in melanoma space, OR validation of tumor site injection with systemic effects.
Since the SARS outbreak in 2003, under the unified arrangements of the Ministry of Science and Technology, Health and Family Planning Commission, the General Logistics Department of the Ministry of Health’s, after 10 years of research, a team led by the Institute of Pharmacology and Toxicology, Academy of Military Medical Sciences researcher Li Song has successfully developed diosmin phosphate oseltamivir capsules, granules and peramivir trihydrate and a series of other anti-flu drugs, some had won the national invention patent and global intellectual property.
With the outbreak of the H7N9 avian influenza, Li Song together with a team performed the H7N9 virus genome sequence analysis, found out that structure of H7N9 virus neuraminidase is stable and N9 homology is greater than 98% suggesting that neuraminidase inhibitors will be effective for the epidemic. Peramivir is a new potent neuraminidase inhibitor which is effective on influenzae type HXNX virus including the recent H7N9 avian influenza.
Li Song said that the research and development of peramivir injection lasted for eight years, and all clinical studies had been completeed in 2011. It passed the technical review of the drug trial centers in December 2012. With the final approval obtained, this H7N9 avian influenza drug is expected to be available in the market soon.
According to Cramer, its BMY
Cramer also said a focus of the conference will include immunotherapy, a treatment that helps the immune system fight cancer.
"This category of drugs could be worth more than $10 billion just in melanoma, lung cancer and kidney cancer alone," Cramer said. "The way to play it? Bristol-Myers. Right now, Bristol's leading cancer immunotherapy play is a drug called Nivolumab that's in phase 3 trials and being studied for melanoma, non small cell lung cancer and renal cell cancer. The consensus on Wall Street is that this could be a $1.8 billion drug, but the data we saw last week was very positive, and if it gets approved for multiple indications, it could be worth $5 or $6 billion in peak sales," Cramer said.
But then again, immunotherapy could mean Vical for a $1.8 billion drug or maybe $5 billion.
Section 382 generally limits the availability of NOLs for post-acquisition periods if there is a 5% shareholder ownership change in the target company. This provision is particularly important to both vulture investment funds and the target bankrupt companies the funds are acquiring. NOLs are often priced in the deal and the parties to the acquisition go to great lengths to make sure that the Section 382 rule is not triggered by the fund’s investment. If the rule is triggered, the utility of the NOLs is lost and the fund’s future cash flows are less than anticipated.
In PRESP-102473-11 the Office of Chief Counsel (Corporate) had to decide whether a group of investment funds should be considered as a single entity for purposes of the 5% shareholder rule of Section 382. This issue is very important because if the funds are considered as a single entity, potentially, the acquisition of stock in the target could evaporate all of the target’s NOLs. In this ruling the funds had varying amounts of overlapping beneficial ownership and were managed by a common group of individuals that acted through several entities and LLC. The bankrupt target was concerned that the investment funds could be viewed as a single acquirer, and thus, trigger Section 382. The target and the funds entered into an agreement whereby the funds could acquire additional shares in the target, provided each fund would own Y shares or less, and the ownership of each fund would be treated separately and not aggregated for Section 382 purposes. If the ownership were aggregated for Section 382 purposes, however, the agreement treated the acquisition by the funds in excess of Y as void ab initio.
The IRS reasoned that an entity for purposes of the 5% ownership rule includes a group of persons who have a formal or informal understanding among themselves to make a coordinated acquisition of stock.
"The response rate of adjudication as I said was completed in May. The adjudication – adjudicative response to data will be locked in July and we expect the top-line results to be released in the third quarter. And we’ll blind – un-blind those results simultaneously I would remind everybody the investigators, who are adjudicating they are not the investigators. The people who are adjudicating the data we are doing in a blinded fashion nobody has access to the data in the third-party database in a blinded fashion. It wouldn’t be unblended till it’s actually transferred to Vical secured source. So, lookout for the results. We are pleased by how we have conducted the trial and we are looking for time lining the results in the third quarter of this year."
Good discussion of Allovectin trial, notes they have a manufacturing facility, other people also using their technology platform, more trials to come. Overall encouraging discussion.
Expect $5-7 bucks in run up to results, then if successful, $15-25, depending on other programs progress, ie Astellas and herpes virus vaccine. Some analysts had a $20 value with 25% chance of success, but that percentage is looking conservative. Singer is right on.
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