ONE PILL. MULTIPLE DRUGS.
Pharma companies should start thinking about which of their drugs are made for each other, because they may soon be able to deploy multiple therapies within one capsule. Researchers at the Georgia Institute of Technology have designed a multiple-compartment gel capsule that can simultaneously deliver different types of drugs. The hydrogel capsules measure less than one micron and are prepared using a “one-pot” method, meaning the drugs would all be contained within the capsule’s hollow shell. The shell, however, is not completely empty. Tethered to the interior of the shell are temperature-sensitive polymer chains that create spatially-segregated compartments, which diffuse from the core when the microcapsule is cooled. This allows the tethered chains to act as hydrophobic drug carriers for multiple distinct drugs.
“We have demonstrated that we can make a fairly complex multi-component delivery vehicle using a relatively straightforward and scalable synthesis,” L. Andrew Lyon, a professor in the School of Chemistry and Biochemistry at Georgia Tech, said in a statement. “Additional research will need to be conducted to determine how they would best be loaded, delivered and triggered to release the drugs.”
The co-delivery of drugs has several potential advantages including synergistic effects, suppressed drug resistance, and the ability to fine tune the relative dosage of various drugs. This method of drug delivery would work particularly well for diseases such as cancer where treatment methods often use combination chemotherapy.
Lyon and Xiaobo Hu, a former visiting scholar at Georgia Tech, created the microcapsules. While Hu was a graduate student at the Research Institute of Materials Science at the South China University of Technology (SCUT) he was co-advised by Lyon and Zhen Tong of the SCUT. Funding was provided for Hu by the China Scholarship Council. —Andrew Matthius
IMAGE IS IMPORTANT
Sure, self-image is important and all, but you can’t just discount how others perceive you—especially if you are a company trying to sell products. SDI’s Pharmaceutical Company Image 2011 study offers a comprehensive analysis of pharmaceutical company and industry image as perceived by key healthcare audiences. A total of 9,800 participants were surveyed in March and April 2011, including physicians from 27 specialties. Among those specialties are obstetricians/gynecologists and cardiologists. Four in ten OB/GYNs hold Pfizer in the highest esteem while Merck, last year’s leader, dropped to third. Warner Chilcott, which ranked fourth, called on OB/GYNs more than any other corporation during the past year. Teva Pharmaceuticals made the third most calls to OB/GYNs but didn’t rank in their top five, while Johnson & Johnson made the 17th most calls but ranked fifth overall. Pfizer also ranked first among cardiologists—who did not rank Forest Pharmaceuticals or Boehringer Ingelheim in their top five even though those two companies ranked second and fifth respectively in calls made to cardiologists. Forest, however, did rise in the ranks from 11th last year to eighth this year. Here is a look at the top five companies ranked by OB/GYNs and cardiologists. —A.M.
MAN-MADE ORGAN
The recipe for a man-made trachea, or windpipe, is quite simple. Start with a glass tube, use some spongy plastic to give it the right shape, spin it like a rotisserie chicken while dripping on some yummy stem cells, add a little bit of growth hormone for taste, let everything marinate for two days, then insert into the patient and listen to him breathe. Best of all— this new organ can be ready in less than two weeks.
Professor Paolo Macchiarini, of Karolinska University Hospital and Karolinska Institutet in Stockholm, Sweden, led the international team that created the first synthetic windpipe and transplanted it into a 36-year-old male suffering from late-stage tracheal cancer who had not responded to other treatment options including surgery, chemotherapy, and radiation, according to the NPR blog Shots. Macchiarini performed similar operations back in 2008 using tracheas from cadaver donors where he stripped those windpipes of all the donor’s cells and replaced them with the patient’s own stem cells. This time he had to start from scratch.
Professor Alexander Seifalian, from University College London, built a synthetic trachea scaffold matching the specifications of the patient’s current windpipe using a medical plastic called polyethylene glycol. This plastic is made of spongy polymers porous enough for stem cells to grow into it, according to the Los Angeles Times. At the same time, a team at Harvard Bioscience was working on a bioreactor in which the trachea could be incubated with the patient’s stem cells (and, yes, spin like a rotisserie chicken to ensure stem cells were equally distributed), according to Shots. After giving the cells two days to grow, Macchiarini inserted the trachea into the patient, stitched him back up, and waited anxiously to learn the results. “It’s working like a normal windpipe,” Macchiarini told Shots. “He’s able to cough. He’s able to expel his secretions. He’s breathing normally. He has the sensation he’s breathing.” The patient also does not have to take immunosuppressive drugs because there is no rejection of the transplant since his own cells were used. —A.M.
FDA UPDATE
An FDA panel unanimously agreed that Roche Holding’s Avastin should no longer be approved for the treatment of breast cancer. This decision followed a rare two-day hearing where several patient advocates tried to make the case for Avastin, but the panel ruled that the drug was not safe or clinically beneficial based on follow-up trials. The Centers for Medicare and Medicaid already released a statement saying that Medicare will continue to cover Avastin for breast cancer regardless of the FDA’s decision. FDA Commissioner Margaret Hamburg is expected to make a final decision later this year.
Sanofi has discontinued the Multaq Phase IIIb PALLAS trial for patients with permanent Atrial Fibrillation (AF). The decision follows recommendations from the study’s Operations Committee and the Data Monitoring Committee which observed a significant increase in cardiovascular events in the dronedarone arm. Multaq is already approved for the treatment of non-permanent AF.
The FDA has posted guidelines for the small number of medical mobile apps that they plan to oversee, including apps that are used as an accessory to an FDA-regulated medical device and apps that transform a mobile platform into a regulated medical device. The guidelines can be viewed at http://tinyurl.com/3rmzzan and the FDA is giving consumers 90 days to offer their input on this proposal. Comments can be submitted online at http://www.regulations.gov/.
The FDA has approved the following brands for the 2011-2012 vaccine season: Afluria, CSL Limited; Fluarix, GlaxoSmithKline Biologicals; FluLaval, ID Biomedical Corporation; FluMist, MedImmune Vaccines; Fluvirin, Novartis Vaccines and Diagnostics Limited; and Fluzone, Fluzone High- Dose and Fluzone Intradermal, Sanofi Pasteur.
Janssen Pharmaceuticals’ Xarelto (rivaroxaban tablets), a novel, once-daily, oral anticoagulant, was approved for the prevention of deep vein thrombosis which may lead to a pulmonary embolism in people undergoing knee or hip replacement surgery.
Medivir announced that its investigational protease inhibitor TMC435 has received “Fast Track” designation by the FDA for the treatment of chronic hepatitis C (CHC) genotype-1 infection based on TMC435’s potential to address unmet medical needs in the treatment of CHC infection. —A.M.
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–Not for use this issue—
The FDA
