The FDA granted investigational new drug approval to the Mayo Clinic for two new cancer vaccines that are among the first aimed at preventing recurrence in breast and ovarian cancer patients. Most cancer vaccines that have been developed fight tumors, but the approach taken by researchers at the Mayo Clinic is to immunize patients after therapy (when they are healthy) in order to prevent relapse. The FDA approval clears the way for Phase 1 clinical trials to begin early next year with 20-25 patients who have been treated for ovarian or breast cancer.
One of the vaccines being tested, however, may ultimately be used as a preventive measure for all women. The vaccine contains fragments of a protein that is abundantly found in breast and ovarian cancer cells, which means the vaccine could be helpful to a vast majority of patients rather than just sub-populations with distinct types of cancer. The second vaccine is designed specifically for breast cancer patients and would be administered after they receive conventional chemotherapy. This vaccine targets the Her2/neu molecule, which promotes the growth of cancer cells. Both vaccines are designed to mobilize the body’s immune system in order to detect and destroy diseased cells.
“I’m quite optimistic that if we can combine early detection, effective conventional therapies and vaccination, we can reduce recurrence and long-term morbidity associated with breast and ovarian cancer,” Mayo Clinic immunologist Keith Knutson, Ph.D., who developed the vaccines with his colleagues, said in a statement.
The Mayo Clinic is not alone in their search for successful cancer vaccines. In fact, there are over 1,150 trials for cancer vaccines listed on ClinicalTrials.gov ranging from Phase 1 to Phase IV trials for a variety of cancers including lung, pancreatic, skin, and prostate.
Robots are quickly becoming a surgeon’s best friend. Surgical robots, such as Intuitive Surgical’s da Vinci Robot, allow for more precise dissections and suturing as well as less blood loss for the patients who also get the extra benefits of fewer scars, less post-operative pain and chance of infection, and a quicker hospital stay and recovery time. These human-controlled slicing and dicing machines also help surgeons make cuts not previously thought to be possible (or just known to be really, really difficult). On August 22, Vincent Obias, MD, Director of the Division of Colon and Rectal Surgery, performed the nation’s first (and perhaps even world’s first) single-incision robotic laparoscopic surgery on the left colon using the da Vinci Robot at The George Washington University Hospital.
“The left colon is technically more challenging for single-incision surgeries. Vital blood vessels and structures are situated close to the colon, requiring a high level of precision,” Dr. Obias explained in a statement. “The robot’s three-dimensional view simulates normal vision. I can see around structures more easily and avoid damaging the ureter, spleen, and major blood vessels. Also, the robot offers more stability, dexterity and triangulation—it’s like having three rock-steady hands rotating 360 degrees to allow optimal manipulation of the tissue.”
Conventional laparoscopic surgery has less stability, triangulation, and dexterity and the procedure typically requires four incisions and a four-day hospital stay. Robotic surgery helps simplify things a bit.
“With just one cut, a foot-long section of the patient’s infected colon was removed through the belly button. Thirty-six hours after surgery, the patient was ready to go home,” Dr. Obias said. —A.M.
EASY BREATHING DETECTION
Wireless networks designed to literally see through walls in order to detect burglars or assess a hostage situation are now being tested for a new purpose—measuring breathing. University of Utah engineers conducted a study to determine how well a network of 20 wireless transceivers placed around a hospital bed could reliably detect breathing. In the study, posted on the online scientific preprint website ArXiv, the wireless network could measure breathing within 0.4 to 0.2 breaths per minute (most breathing monitors round to the nearest breath per minute), however the current wireless system could not measure breathing while a person moved.
In 2009, two of the engineers, senior author of the study and assistant professor of electrical engineering Neal Patwari and then-graduate student Joey Wilson, demonstrated how a couple dozen wireless transceivers could be used to see right through walls. They formed Xandem Technology, a University of Utah spinoff company, to commercialize the wireless networks for use as motion detectors, to help police locate hostages, and even alert vacationing parents if their teenagers are partying during their absence. Now Patwari hopes to develop monitors to help noninvasively measure breathing.
“We can use this to increase the safety of people who are under sedation after surgery by knowing if they stop breathing,” Patwari said in a statement. “We also envision a product that parents put around their baby’s crib to alert them if the baby stops breathing. It might be useful for babies at risk of SIDS.”
This new method would not require the patient or baby to be hooked up to any wires or tubes, which can make sleeping—and the overall hospital experience—uncomfortable. This type of monitor could also be helpful for adults with sleep apnea, according to Patwari who is already planning further research to determine the best way to measure breathing with this wireless method. —A.M.
The only over-the-counter asthma inhaler sold in the United States will no longer be available after December 31 as part of a phase-out of epinephrine inhalers containing chlorofluorocarbons (CFCs). Epinephrine CFC inhalers, marketed as Primatene Mist by Armstrong Pharmaceuticals, are being phased out because they use CFCs, which decrease the earth’s ozone layer.
Matrix Laboratories Limited, a subsidiary of Mylan, received tentative approval from the FDA through the President’s Emergency Plan for AIDS Relief (PEPFAR) for Lamivudine / Tenofovir Disoproxil Fumarate Tablets, co-packaged with Nevirapine Tablets. This is the first generic ARV drug product in a co-pack form and can be used alone or in combination with other ARVs for the treatment of HIV/AIDS. The product will be eligible for purchase outside the U.S. in certain developing countries.
The Oncologic Drugs Advisory Committee
(ODAC) to the FDA voted 10-2 to recommend the accelerated approval of ApoPharma’s Ferriprox (deferiprone), an oral iron chelator, for the treatment of patients with transfusional iron overload when current chelation therapy is inadequate.
Pfizer’s Xalkori (crizotinib) was approved to treat certain patients with late-stage (locally advanced or metastatic), non-small cell lung cancers (NSCLC) who express the abnormal anaplastic lymphoma kinase (ALK) gene. Xalkori is being approved with a companion diagnostic test, Abbott Molecular’s Vysis ALK Break Apart FISH Probe Kit, which will help determine if a patient has the abnormal ALK gene.
Alexion Pharmaceuticals announced that Soliris (eculizumab) was approved for the treatment of all pediatric and adult patients with atypical hemolytic uremic syndrome (aHUS), an ultra-rare, life-threatening, genetic disease that progressively damages vital organs, leading to stroke, heart attack, kidney failure and death.
An FDA advisory panel voted to recommend the approval of Xarelto, from Johnson & Johnson and Bayer AG, for the treatment of the heart rhythm disorder atrial fibrillation (AF). The FDA is expected to make a final decision by early November. —A.M.