In the fall issue of Vital Signs, Marlies Sproll, Ph.D., the CSO of MorphoSys, discusses a new antibody in the pipeline for the treatment of Alzheimer’s. Developed by Roche with the support of MorphoSys’ HuCAL technology, this new antibody gantenerumab is currently in Phase 1 clinical trials:
“Alzheimer’s disease (AD) affects 5.3 million people and is the seventh leading cause of death and the most common type of dementia in the United States. Alzheimer’s is an incurable, progressive disease, and the treatments currently available only serve to alleviate its symptoms. Thus, AD represents the largest unmet need in neurology. Early diagnosis and therapeutic strategies that could delay the onset and progression of this debilitating disease would be considered a success…Pathological hallmarks of AD are the deposits of extracellular amyloid-beta (Aβ) plaques, intraneuronal tangles—composed of hyperphosphorylated tau—,and cerebral neuronal loss. Therefore, strategies to develop drug candidates with potential disease-modifying effects tend to focus on inhibiting Aβ production and aggregation or they aim to increase the Aβ clearance from the brain.”
“Preclinical tests have demonstrated the high specificity and affinity of this MorphoSys/Roche HuCAL antibody, gantenerumab, and its ability to dissolve accumulated Aβ plaques in vitro.”
Recent reported outbreaks of MRSA (high-school athletes in Iowa, a child in Washington and inhabitants of a Maine lobstering island) show that community-acquired antibiotic-resistant infections remain a significant issue for the American public.
According to Reuters, data released by the CDC last week suggest that , “Americans are more than six times as likely as Britons to contract the superbug in the community, although rates of hospital-acquired infections are about the same.” Estimates from 2005 suggest that MRSA caused 95,000 serious infections in the U.S. and caused 18,500 deaths.
Not only are efforts to curb infection in hospitals and in the community limited in their success, but the few drugs used to treat MRSA (e.g. vancomycin) are not always effective against different strains. Most antibiotics approved to treat MRSA are injectable (with the exception of oral Zyvox) meaning that serious community-acquired MRSA infections must be treated in the hospital. There are, however, new promising candidates in the pipeline.
One example is Cempra’s promising drug candidate for treating drug resistant infections, Taksta (sodium fusidate – has completed Phase 2 trials). Taksta has a history of safety and efficacy outside the U.S., but holds promise for treating MRSA in the American population due to its low risk for resistance. Because Americans have not been in contact with this particular anti-infective, local strains of MRSA and other gram-positive infections have not yet developed resistance against it.
Of course, ‘superbugs,’ as highly drug-resistant infections are called, are constantly evolving to challenge the drugs developed to eradicate them. As such, the anti-infective pipeline must remain strong and determined to innovate to treat the newest strains of infectious disease.
Today, an estimated 170 million people worldwide are chronically infected with the hepatitis C virus (HCV). Chronic HCV infection, the leading cause of liver transplantation, can result in fibrosis and cirrhosis of the liver, liver cancer as well as liver failure. Troublingly, the current standard of care, which includes a combination of injectable and oral antiviral treatments, leads to severe side-effects and only cures about 50 percent of patients treated for the most common strain of HCV. The other half of patients, which is comprised of patients who either cannot tolerate sustained therapy, untreated patients and those patients for whom the treatment does not work, form a lucrative target in today’s drug development landscape.
HCV’s standard of care is a combination of injected interferon-a (INF-a), on of the body’s natural immune responders, and ribavirin, an oral generic antiviral. Now, drug developers are approaching the problem of HCV from a couple of different angles.
The most advanced drugs in development (currently in Phase 3 trials) include Vertex’s telaprevir and Schering/Merck’s boceprevir. These oral antivirals aim to complement INF-a treatment and improve outcomes for today’s treated population. A recent survey of 100 physicians who treat ~20,000 HCV patients (carried out by Morgan Stanley) suggested that telaprevir is the favorite of the two. While there is hope that oral agents may ultimately replace injectables, studies have not yet supported this hypothesis.
Some companies with drugs in the earlier stages of development are hoping to replace the injectable form of INF-a with a more tolerable injectable that would similarly encourage the body to attack the virus. One example is Idera Pharmaceuticals whose intectable IMO-2125 (Phase 1) is a synthetic agonist of a receptor that activates one of the body’s innate immune responses, a process that includes the release of constitutive INF-a and other cytokines. Early positive results suggest that keeping the immune response and INF-a localized ‘in-house’ may improve tolerability for patients who cannot sustain the current standard of care. Instead of complementing today’s difficult regimen of INF-a injections, IMO-2125 may be a better drug to work with oral antiviral agents.
The April, 2010, approval of Dendreon’s Provenge for the treatment of prostate cancer was said to mark “the beginning of an era in which patients’ own immune systems become part of the standard therapeutic arsenal against cancer.” Provenge is a personalized immunotherapy designed to fight cancer by the creation of a bespoke vaccine that trains a patient’s body to fight the disease. Physician’s agree that the one size fits all approach to cancer treatment is no longer working, however the promise of personalized immunotherapy is not without its challenges.
The revelation of the cost and labor involved in the production of Provenge has recently caused controversy. Skilled lab technicians prepare the vaccine by hand using the patient’s own cells, and the dose must be administered within hours of preparation, otherwise it becomes inactive. As a result of the labor-intense process, the cost of a single treatment of Provenge is $93,000.
Because of the complicated nature of the preparation and the limited production volume possible, Provenge is one of the first drugs to be rationed in the last 15 years. At the University of Texas M.D. Anderson Cancer Center, only two patients (selected by lottery) out of a possible 150 can be dosed per month.
Of course, Provenge is the first approved drug of its kind. Scientists and physicians certainly see the potential for experimental cancer vaccines and believe that further innovation can lead to more automated and more affordable manufacturing.
An example of the new technology available for manufacturing personalized immunotherapy is called Arcelis. Developed by Argos Therapeutics, Arcelis is a more automated system that can produce five years worth of doses in only one run and enables the resulting vaccines to be frozen for years, not hours or days. The limited supervision required also decreases the cost of labor and subsequently the cost of treatment. The most advanced drug manufactured with Arcelis has completed Phase 2 trials in renal cell carcinoma.
Arcelis has the potential to make personalized immunotherapy like Provenge more accessible to patients, more attractive to insurers and promises makes the development of this type of therapy more realistic for a wide variety of diseases beyond cancer.
An interesting perspective from David J. Weatherall, one of this year’s Lasker Prize winners, in The New York Times:
Q. IN YOUR ACCEPTANCE SPEECH FOR THE LASKER PRIZE, YOU COMPLAINED THAT MANY OF THE INTERNATIONAL HEALTH ORGANIZATIONS IGNORE GENETIC DISEASES. WHY IS THAT?
A. They don’t think enough people are impacted, so they are more interested in solving communicable diseases. Well, they are making progress with those, but they recognize that once you do that the frequency of the genetic diseases increases. As you start to control infections, you lower childhood mortality and many children with genetic diseases who might have died in their first years are living long enough to present for treatment. They have to deal with that.
What happens when PepsiCo decides to use a group-blogging site that is home to some of the best-known science bloggers to host their promotional blog “Food Frontiers”?
They get get kicked off, according to the Fall 2010 issue of ScienceWriters.
The group-blogging site was ScienceBlogs, and the reason for PepsiCo’s dismissal was protest and discontent.
Initially, certain bloggers on the site were concerned with issues such as the risk for advertising bleeding into editorial content or a blog written exclusively by a commercial sponsor. Many did not appreciate the blurring of the line between journalism and self-promotion.
Some were not as concerned, and merely viewed the site as a hosting platform. As such, the integrity of “ScienceBlogs” would not necessarily implicate the integrity of those blogs hosted on the site.
Ultimately, some high-profile bloggers left the site, may of whom, the article notes, were journalists. Journalists are the group for whom the line between advertorial and editorial is most significant and most defined.
According to the author, “Readers of today’s pubs expect that editorial content can be distinguished from ads with ease.”
Branding PepsiCo’s blog “advertorial” by the ScienceBlogs staff was not sufficient for the disgruntled bloggers because it does not effectively convey to the general public that this was more likely an advertisement.
Rather, the eventual discontinuation of “Food Frontier’s” hosting on the site was the first step in appeasing those who felt compromised and opened the door for the more significant discussion of advertorial blogs: Is it easy to distinguish between the journalistic voice and the corporate agenda?
Chief Justice John G. Roberts sold around $15,000 in Pfizer stock on Aug. 31 this year so that he could hear two upcoming cases involving the drug maker. According to Duff Wilson’s post on The New York Times blog Prescriptions, the implications of this choice are slightly more compelling than initially meets the eye:
“Supreme Court rules generally require justices to recuse themselves from any case involving any party in which they have a financial interest. Justice Roberts’s action means that eight of the justices can participate in the Pfizer cases. It also raises the possibility of 4-4 tie votes.”
In one case, a tie vote would uphold an appellate court’s ruling on the case involving a Pennsylvania law suit brought by parents of a child who suffered seizures following treatment with a Wyeth (now Pfizer) vaccine.
In the other, the tie vote would go against the drug maker and uphold a lower court ruling that involved a pricing case from California.
What began as a conflict of financial interest has become a case where the Supreme Court’s inability to make a decision one way or another will do little but allow the last judiciary decisions to stand. It also means that Justice Roberts will not have to wager his personal investment portfolio on choices made by the Supreme Court without his input.
This may also be the kind of news that charges the investor relations professional with the task of explaining the various implications and possible scenarios of a single decision by a very powerful man to a diverse and extensive investment community audience. It will be interesting to follow this particular investment communications strategy going forward.
Many know of LinkedIn as a source for networking — the Facebook of the professional world. It allows the individual to connect with their peers by industry or academic connection, and today most job hunters use LinkedIn to distribute CVs and references.
LinkedIn is also a tool for the social media savvy individual or organization to monitor and drive conversations among their target audiences.
Thought leadership is an important part of any reputation management initiative, and by definition thought leadership implies the participation in the greater industry conversation. Through LinkedIn Groups, you have the ability to use a social media vehicle that is already mainstream among professionals to:
- Quickly discover the most popular discussions in your professional groups.
- Have an active part in determining the top discussions by liking and commenting.
- Follow the most influential people in your groups by checking the Top Influencers board or clicking their profile image to see all their group activity.
- See both member-generated discussions and news in one setting.
- Find interesting discussions by seeing who liked a discussion and how many people commented
Initially it is easy to peruse the available Groups and discussions and to track the current themes among your audience. Once you have determined your level of interest in participation, you can join discussions and then actually start your own.
As the face of your organization, your thought leadership lends credibility to the greater objectives of the company itself. Beyond the networking opportunities, LinkedIn allows you to link in to the industry conversation.