New study confirms worst fears about Merck’s HIV vaccine

Posted under Biologics, Blog, Companies, Diagnostics, Funding, HIV, HIV/AIDS, Medical Devices, Medical Supply, Merck, NIH, Pharmaceuticals, R&D, Startups, Universities, Videos by John Carroll

Five years ago Merck ($MRK) investigators stunned everyone working in the AIDS research field with the news that they were abruptly halting a study of a prospective HIV vaccine after the data began to make clear that it wasn't only failing to guard against the virus, but appeared to increase the risk of becoming infected. Now researchers have followed up to confirm that the worst case scenario was true.

The sudden about-face on the vaccine forced investigators as well as the NIH to do some serious rethinking about the R&D work being done on HIV vaccines. Not knowing exactly what went wrong, another big trial was scrapped on a similar vaccine. And as The New York Times reports today, further work has been carried out in slow motion, delivering at best mixed results.

The new study tracked the health of 1,836 men enrolled in the Merck trial for a further two years. Almost 10% later became infected, with uncircumcised men and men with high levels of antibodies for the Type 5 adenovirus most at risk. As the vaccine was constructed using a weakened adenovirus 5, scientists speculate that may have boosted the presence of CD4 cells in the blood, creating the kind of "target-rich" environment that HIV thrives on.

But that's conjecture. Investigators still aren't certain what went wrong, only concluding that the result had to be biologic. As a cautionary tale, the Merck trial will continue to serve as a reality check for everyone in the field.

- here's the story from The New York Times

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Genentech drug picked for pioneering $100M Alzheimer’s trial

Posted under Alzheimer's, bapineuzumab, beta amyloid, Blog, Companies, crezenumab, Diagnostics, Funding, Genentech, Medical Devices, Medical Supply, NIH, Pharmaceuticals, Pipeline, semagacestat, solanezumab, Startups, Universities, Videos by john

The NIH has agreed to help bankroll a pioneering $100 million study of Genentech's experimental Alzheimer's therapy crenezumab. Investigators will test the drug in a region of Colombia where a particular genetic mutation is known to trigger the early onset of Alzheimer's, with an eye to determining if they can stop the memory-wasting ailment before it starts.

The NIH has agreed to pay for $16 million of the study, with private donors putting up $15 million more and Genentech adding the rest--about $65 million--to bankroll the effort. The announcement is part of an ambitious effort announced Tuesday to find an effective treatment for the disease by 2025 in the hopes of thwarting a steadily growing epidemic of Alzheimer's as the baby boomer generation turns gray and old.

The news is a coup for Genentech, which had one of 25 therapies considered for the public/private study. Like a number of other therapies in the pipeline, crenezumab targets the toxic protein beta amyloid, which accumulates in the brain of Alzheimer's victims. But while amyloid remains a prime suspect in the disease, investigators have yet to determine whether eliminating or reducing the levels of toxic material is a safe and effective approach to treating the illness.

Earlier attempts to target beta amyloid have met with failure, if not outright disaster, as was the case with Eli Lilly's ($LLY) semagacestat. But in a common strategy, investigators have been testing the treatments in patients with advanced cases. In this instance, the drug will be studied in patients who have yet to see the disease develop to the point where it has already wreaked havoc on the brain. Investigators also believe that crenezumab may be less likely to cause tiny brain hemorrhages which can afflict patients. The drug is currently in mid-stage testing after completing positive early-stage groundwork.

"This will be the first test of an anti-amyloid treatment in a preclinical stage, where it has the best chance to have the most profound benefit," Dr. Eric Reiman, executive director of Banner Alzheimer's Institute, told reporters today. Banner is leading the study.

Two other drugs, bapineuzumab and solanezumab, are in late-stage studies that wrap this summer. Analysts have generally been skeptical of the outcomes, noting the deep uncertainties that surround the disease and past failures.

The news is also a boon to AC Immune, a Swiss company which partnered with Genentech on the program back in 2006.

- get the story from Reuters
- here's the article from The New York Times

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NIH, U.S. agencies pay for nearly half of global health R&D

Posted under Blog, Companies, Diagnostics, FDA, Funding, Global Health Technologies, HIV, Medical Devices, Medical Supply, NIH, Pharmaceuticals, R&D, Startups, Universities, Videos by rmcbride

Uncle Sam has been a champion of backing research of global health concerns that plague populations well outside of U.S. borders, according to a study by Global Health Technologies. In fact, U.S. agencies led by the National Institutes of Health have footed 45% of the bill covering research of diseases such as HIV and other scourges to global health, spending $12.7 billion over the past decade. Yet much of that funding went into basic research, and the study calls for greater focus on backing work to translate findings into treatments. Article

Pharma giants offer up drug candidates for $20M NIH collaboration

Posted under AstraZeneca, Blog, Companies, Diagnostics, Eli Lilly, Francis Collins, Funding, Medical Devices, Medical Supply, NCATS, neuroscience, NIH, Pfizer, Pharmaceuticals, R&D, Startups, translational medicine, Universities, Videos by john

NIH director Francis S. Collins has made no secret of just how eager he is for the new translational medicine initiative now underway to rev up work on therapies bound for clinical review. Today he's taking a big step down that road, outlining a new partnership between the National Center for Advancing Translational Sciences (NCATS) and Eli Lilly ($LLY), Pfizer ($PFE) and AstraZeneca ($AZN) that will provide investigators access to failed drugs to see if they can be repurposed for new uses. And the government has a $20 million cache of cash to fund the work.

The idea is simple: The drug companies will offer up their data and investigators will have a chance to explore new uses, with a set of deal templates in place to help speed the process on 20 programs. In drug research, it's not at all unusual to see a drug intended for one disease work in another. Reata, for example, found that out with their lead therapy, now partnered with Abbott Laboratories ($ABT). And if shelved therapies can be repurposed, researchers will already have safety data in hand to accelerate development efforts.

"Clearly, we need to speed the pace at which we are turning discoveries into better health outcomes," said NIH Director Collins. "NIH looks forward to working with our partners in industry and academia to tackle an urgent need that is beyond the scope of any one organization or sector." 

The big three pharma companies at the heart of this deal are likely to be joined by other big players. The NIH says others may join after the pilot gets started. And the approach could help revive work on neuroscience drugs, where some of the industry's biggest players have either stepped back or dropped out altogether.

- here's the press release

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