March 30th, 2015

Harnessing the Power of the Poliovirus as a Cancer Cure

brain_tumorPolio, a highly infectious and crippling disease, was certainly one of the most feared viruses in the 20th century. Each year, thousands of children were left paralyzed. Polio has been successfully eliminated in the U.S. for decades due to a widespread vaccine program. So why would a group of researchers be interested in injecting the poliovirus directly into the brain of a patient?

Clinical trials are now ongoing and research is revisiting the poliovirus in new and hopeful ways, ironically to help battle deadly cancers. Glioblastoma multiforme is one of the most common and fatal brain cancers. Gliobastomas are aggressive tumors that occur in the brain or spinal cord leading to headaches, nausea, seizures, blurred vision and a host of other unpleasant effects. The tumors grow quickly and often leave patients with only months to live. Treatments for glioblastoma involve surgery to remove the tumor, followed by radiation treatment and chemotherapy. Unfortunately, the recurrence rate for glioblastomas is near 100%, with an average time to recurrence of six to seven months. Glioblastomas will double in size every two to three weeks if left untreated.

There is no FDA-approved cure, but it seem to be getting much closer each day, thanks in part to the poliovirus. At the Preston Robert Tisch Brain Tumor Center at Duke University Medical Center in Durham, NC, medical experts have been painstakingly working on a treatment for glioblastoma for over a decade and a half. Their result: a genetically modified poliovirus, known as PVS-RIPO.

How does it work? The poliovirus is genetically modified with a portion of a rhinovirus (which causes the common cold) inserted into the poliovirus. This prevents the poliovirus from replicating and causing polio disease. The PVS-RIPO kills cancer cells but not healthy cells because it requires certain elements found only in cancer cells to be effective. The poliovirus receptor is found on most tumor cells, and this is what allows the agent to seek out and destroy the cancer. PVS-RIPO also helps to elicit the patient’s own immune response against the cancer. The patient’s immune system recognizes the virus and initiates it’s own disease-fighting process, much the same way that a cold or cough virus is warded off.

The process of receiving the PVS-RIPO treatment is straightforward. Patients receive a 6.5 hour infusion of the PVS-RIPO treatment through a catheter inserted into the brain tumor using only a local anesthetic. No further treatment is required. Follow-up appointments, including MRI scans and neurological exams, track the treatment effectiveness, side effects, and tumor growth.

Research with PVS-RIPO is in the early stages, in Phase I trials, where clinicians are working to determine the appropriate dose in humans to kill the tumor and limit side effects. Early results have been successful in many patients and remarkably few toxic side effects, with the correct dose, have been detected.

For some patients, results have been astonishing. One young woman, a nursing student at the time, received the experimental injection in 2012. Now, three years later, no active glioblastoma cancer is present on her MRI scan. An older man, a physician has been in remission – one might call it cancer-free – for three years, too. A mom from Georgia is having success, and hopeful to see her son’s graduation. Other patients are doing well, too. But it seems these patients may have received the correct dose. It’s important for patients to understand that overall, 11 of 22 patients have died after treatment, and complications in some may have occurred due to higher doses tested in the dose-ranging trials. The treatment is not without risk, although early results are very promising.

Studies are now moving in Phase II and III trials to determine effectiveness and get on a track towards a hopeful FDA approval. Clinical development will include more adult studies in glioblastoma, research in children with glioblastoma, and studies in other cancer types, such as prostate, melanoma, pancreas, lung, breast cancer and metastasized brain cancers that have originated from other tumors.

If you have a primary brain or spinal cord tumor, and are interested in a consultation at the Preston Robert Tisch Brain Tumor Center, please visit their referral page. Also, you may contact the Preston Robert Tisch Brain Tumor Center at Duke at (919) 684-5301. Eligible patients must meet certain requirements to enroll.

Join the Drugs.com Brain Tumor Blog to stay up-to-date on the latest news and communicate with those who have similar concerns.

Sources:
Duke University Medical Center. The Preston Robert Tisch Brain Tumor Center. Research Programs. Clinical trials for adults. A Phase I Clinical Trial for Recurrent Glioblastoma Patients Opens for Accrual at the Preston Robert Tisch Brain Tumor Center. Accessed March 30, 2015 at http://www.cancer.duke.edu/btc/modules/Research3/index.php?id=41

Duke University Medical Center. The Preston Robert Tisch Brain Tumor Center. Research Programs. Clinical trials for adults. Dose-Finding and Safety Study of an Oncolytic Polio/Rhinovirus Recombinant Against Recurrent Glioblastoma Accessed March 30, 2015 at http://www.cancer.duke.edu/btc/modules/ClinicalTrials4/index.php?id=111

Killing Cancer. CBS 60 Minutes. Aired March 29, 2015. Accessed March 30, 2015 at http://www.cbsnews.com/news/polio-cancer-treatment-duke-university-60-minutes-scott-pelley/

Kroll D. What 60 Minutes Got Right and Wrong on Duke’s Polio Virus Trial Against Glioblastoma. Forbes. 3/30/2015. Access Match 30, 2015 at http://www.forbes.com/sites/davidkroll/2015/03/30/60-minutes-covers-dukes-polio-virus-clinical-trial-against-glioblastoma/

Last revised: March 31, 2015

January 6th, 2015

Biosimilars in 2015: What Can We Expect?

On Friday, March 6th, 2015 the FDA approved Sandoz’s Zarxio, the first official biosimilar that will be made available in the U.S.

Zarxio, a recombinant granulocyte colony-stimulating factor used to boost white blood cells after cancer treatments, is the long-awaited biosimilar for filgrastim (Amgen’s Neupogen).

The FDA noted in their briefs that Zarxio was “highly similar” to the brand biologic and had “no clinically meaningful differences between the proposed product and the reference product in terms of safety, purity, and potency”. The FDA stated that “robust” pharmacokinetic and pharmacodynamic comparative studies supported biosimilarity with the original filgrastim.

I’ll admit it, as a pharmacist the topic of biosimilars peaks my interest. Europe has been marketing biosimilars for years now, and the Food and Drug Administration (FDA) is developing long-awaited standards so that this process can be initiated in the U.S. And it looks like this week, the process is finally starting.

But there are many questions still to be answered:

  • What biologics are in-line to be the first approved biosimilars?
  • Where will health care providers find information about biologic interchange with biosimilars?
  • How much cheaper will a biosimilar be as compared to its brand counterpart?
  • Can pharmacists automatically make a switch between a biologic and a biosimilar without prescriber approval?

The current state of biosimilars, and their FDA standards, is still in process in the U.S. Take a look at our article to review the controversial issues, learn facts about biosimilars, and see upcoming biosimilars in the pipeline for approval down the road.

http://www.drugs.com/news/biosimilars-2015-can-we-expect-55159.html

Updated 3/11/2015

September 23rd, 2014

Drugs.com Adds Mayo Clinic Disease Reference

Drugs.com is pleased to announce it has licensed select content from Mayo Clinic to provide more timely and trustworthy medical condition and disease information.

The articles include detailed information about medical diseases such as allergies, back pain, depression, erectile dysfunction, and type 2 diabetes. Each article includes informative sections which may include an overview, symptoms, when to see a doctor, how to prepare for your appointment, disease causes, tests and diagnosis, disease risk factors and prevention strategies. We know you find this new addition to our website useful and reliable.

Mayo Clinic http://www.mayoclinic.org/ is a nonprofit worldwide leader in medical care, research and education for people from all walks of life. Their mission is to inspire hope and contribute to health and well-being by providing the best care to every patient through integrated clinical practice, education and research.

Visit the new Mayo Clinic disease information here: http://www.drugs.com/mcd/

July 14th, 2014

Fox News Features Drugs.com Medication Guide app

Thanks to Fox News for showcasing the Drugs.com Medication Guide app today. Very much appreciated.

Available in both the Apple App store and the Google Play store, this is a great app for ultra-quick research and/or keeping track of multiple meds.

Check out the video at the link below…

http://www.foxnews.com/health/2014/07/13/drugscom-app-provides-medical-information-on-go/

And check out the apps here…

http://www.drugs.com/apps/

April 3rd, 2014

Consumer Reports Gives the Thumbs Up to the Drugs.com Pill Identifier App

Consumer Reports just put out a review of seven pill identifier apps. Here’s a snippet…

“We reviewed seven apps that can help identify the pills you take, and liked two of them a lot: Drugs.com Pill Identifier and Epocrates Pill ID. The others—CVS/Pharmacy Pill Identifier, iPharmacy Pill Identifier, Pill Finder, Prescription Pill Identifier, and ID My Pill—didn’t fare as well.

The Drugs.com app, the user-friendlier of the two, also provided links to relevant news about each drug. ”

View the full report here…

http://www.consumerreports.org/cro/news/2014/04/best-pill-identifier-apps/index.htm

And you can download the app here…

https://itunes.apple.com/us/app/pill-identifier-lite-by-drugs/id398305495?mt=8

 

March 4th, 2014

Introducing the Drugs.com redesign

After a lot of effort from our NY brand agency and in-house designers, we have started to roll out a new look for Drugs.com. First step is a logo and menu change. At the same time we have a team working through updating all the mobile apps, Facebook, Google+, Twitter and Youtube channels. Wow, we’re spread far and wide nowadays.

It’s not just a new brand image. As part of the upgrade process, we will also be pushing out significant usability upgrades over the coming months. We are channeling most of our resources into improving the user experience (UX is the geek term) making everything better, faster, simple and clear. We hope you’ll like it.

February 10th, 2014

Q4 2013 Drug Sales Data Released: Tecfidera Growth On a Rapid Transit

Drugs.com has released the latest U.S. drug sales data. While the ranking of the top three drugs by sales — Abilify, Nexium and Humira — remains the same, Lilly’s Cymbalta drops from fourth to seventh and forfeits close to $319 million in sales due to generic availability. Nexium’s growth tapers too, possibly due to looming patent loss and an up-and-coming Rx-to-OTC switch. Crestor, AstraZeneca’s top cholesterol drug with market exclusivity until 2016, slides up one notch to number four, and GSK’s Advair Diskus returns to round out the top five. Tecfidera, predicted to be a blockbuster in Biogen Idec’s multiple sclerosis portfolio, continues to gain strength with a 20 percent climb in sales.

View the full data here…
http://www.drugs.com/stats/top100/sales

February 6th, 2014

Drugs.com and TrialReach to Give Patients Access to Drugs In Development

Drugs.com, the leading online clinical drug resource, and TrialReach are partnering to provide patients with information and access to treatments that are still under development. This partnership will bring TrialReach’s patient-centric content and tools directly to the 25+ million people who visit Drugs.com every month.

From a patient’s perspective, clinical trials offer more treatment options when the standard ones fail. They also give patients the opportunity to participate in medical research that may also help other patients in the future.

We hope to have integration complete during the current quarter.

More information here:

http://www.drugs.com/news/trialreach-give-patients-access-development-50308.html

December 30th, 2013

Looking Back at 2013

The end of the year is always a good time to reflect back on healthcare innovations, major drug approvals, and frankly, things that could have possibly gone a tad bit better. From advances in hepatitis C virus treatments, to over-the-counter availability of emergency contraception, the year had lots of positive healthcare hits.

But a few misses were thrown in too – let’s not forget about the doping scandal with Lance Armstrong on Oprah Winfrey’s network, and the government’s faulty Healthcare.gov website that left millions without a way to join Obamacare.

Most important, and most gratifying for many patients, are the new drug approvals made by the FDA in 2013. These new medications open healthcare options for patients that range from increased adherence due to easier dosing regimens, to extending survival time for patients with metastatic cancer, to a viral cure of a liver-robbing disease.

It’s easy for some people to argue that the U.S. healthcare system is flawed. It’s the negative stories that stand out — those are the ones that everyone remembers. But it’s important at the end of the year to remember the successes, too, and be hopeful for more healthcare advances, and fewer healthcare misses, in 2014.

For more details, watch the End of Year Round-Up Slideshow

November 7th, 2013

Q3 2013 Drug Sales Data Released: Top Five Drugs Each Post Over $1 Billion in Sales

The latest U.S. drug sales data has been released by Drugs.com. Rankings for the top five drugs by sales remain unchanged in the third quarter. Otsuka’s antipsychotic Abilify and AstraZeneca’s Nexium retain their number one and two spots, respectively. Nexium, the top proton pump inhibitor faces sizable over-the-counter competition, a looming Rx-to-OTC switch, and patent loss in 2014. AbbVie’s Humira, Eli Lilly’s Cymbalta, and AstraZeneca’s Crestor round out the remaining top five.

View the full data here…
http://www.drugs.com/stats/top100/sales