Feature Channels: Pharmaceuticals

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Eighty-three percent of cancer doctors report that they’ve faced oncology drug shortages, and of those, nearly all say that their patients’ treatment has been impacted, according to a study from researchers at the Abramson Cancer Center and the Perelman School of Medicine at the University of Pennsylvania that will be presented today at the 2013 annual meeting of the American Society of Clinical Oncology (Abstract #CRA6510). The results showed that shortages – which have hit especially hard among drugs to treat pediatric, gastrointestinal and blood cancers – have left physicians surveyed unable to prescribe standard chemotherapies for a range of cancers.

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Adding bevacizumab (Avastin) to standard chemotherapy and radiation treatment does not improve survival for patients newly diagnosed with glioblastoma, a very aggressive form of brain cancer, researchers have found. The results of the large, multicenter study are being presented today at the American Society of Clinical Oncology (ASCO) annual meeting.

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A Radiation Therapy Oncology Group trial found that adding bevacizumab to initial treatment for glioblastoma did not improve patient overall survival or progression-free survival,. Results were reported June 2 at the plenary session of the American Society of Clinical Oncology 2013 Annual Meeting.

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Gene panel may help personalize therapy for aggressive brain tumors.

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Many glioblastoma patients treated with bevacizumab (Avastin®) have significant deterioration in neurocognitive function, symptoms and quality of life.

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On Wednesday, 5/29/13, the Wall Street Journal published an article titled “Africa’s Malaria Battle: Fake Drug Pipeline Undercuts Progress.” The piece outlines a counterfeit pharmaceutical problem that is top of mind at Saint Mary’s College where chemistry researchers have developed Paper Analytical Devices (PADs) that can screen whether an antimalarial drug is real.

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Charles H. Hennekens, M.D., Dr.P.H. and colleagues from around the world, under the direction of the Clinical Trial Service and Epidemiology Studies Unit at the University of Oxford, conducted a world-wide meta-analyses using individual participant data from 280 trials of NSAIDs vs. placebo and 474 trials of NSAID vs. another NSAID, which involved a total of 353,809 participants and a total of 233,798 person-years. These results address risks and benefits of drugs used for relief of inflammatory arthritis including cardiovascular disease and other relevant outcomes such as gastrointestinal effects.

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New guidelines to ensure the safe and effective use of blood thinners have been developed and endorsed by the Anticoagulation Forum.

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A drug commonly used to treat depression and anxiety may improve a stress-related heart condition in people with stable coronary heart disease, according to researchers at Duke Medicine.

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Among patients with stable coronary heart disease and mental stress-induced myocardial ischemia (MSIMI), 6 weeks of treatment with the antidepressant escitalopram, compared with placebo, resulted in a lower rate of MSIMI, according to a study in the May 22/29 issue of JAMA.

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A novel approach to obstructing the runaway inflammatory response implicated in some types of asthma has shown promise in a Phase IIa clinical trial, according to U. S. researchers.

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A new study of both computer-created and natural proteins suggests that the number of unique pockets – sites where small molecule pharmaceutical compounds can bind to proteins – is surprisingly small, meaning drug side effects may be impossible to avoid.

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Honokiol is a powerful polyphenol compound extracted from Magnolia officinalis bark. Extensive pre-clinical research shows that honokiol (pronounced ha-no-kee-ohl) supports cellular health and provides gentle relaxation, as well as being a potent antioxidant. In addition, a study published in the European Journal of Pharmacology has found that the botanical extract protects muscles from the normal inflammation caused by intense exercise. This study broadens honokiol’s acknowledged benefits in supporting and maintaining overall health and wellness.

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Expensive, state-of-the-art medical devices and surgeries often are thwarted by the body's natural response to attack something in the tissue that appears foreign. Now, University of Washington engineers have demonstrated in mice a way to prevent this sort of response. Their findings were published online this week in the journal Nature Biotechnology.

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A commentary and review provides clinicians with the optimal utilization of aspirin to treat and prevent heart attacks, and advice on aspirin in the prevention of colorectal and other cancers.

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Nanopharmaceuticals are beginning to demonstrate their capacity to place the drugs directly in the tumor, where they will do the most good, rather than let them roam freely in the body.

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A Wayne State University researcher has successfully tested a technique that can lead to more effective use of nanoparticles as a drug delivery system.

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New VA, U-M research finds no increased risk of abnormal heart rhythms, death despite FDA warning against high-dose citalopram dosages.

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Papers presented in pair of leading neurosurgical journals reveal interesting new findings on dabigatran etexilate (Pradaxa®) and intracranial hemorrhage.

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JACKSONVILLE, Fla. — Researchers at Mayo Clinic’s campus in Florida have discovered a protein that is overly active in every human sample of kidney cancer they examined. They also found that an experimental drug designed to block the protein’s activity significantly reduced tumor growth in animals when used alone. Combining it with another drug already used to treat the cancer improved the effectiveness of both.

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Selective serotonin reuptake inhibitors (SSRIs) – among the most widely prescribed antidepressant medications – are associated with increased risk of bleeding, transfusion, hospital readmission and death when taken around the time of surgery, according to an analysis led by researchers at UC San Francisco and Baystate Medical Center in Springfield, Mass.

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Absorption Pharmaceuticals announced today that the U.S. Patent and Trademark Office has indicated that it will grant a patent related to the use of its topical medication, Promescent, for premature ejaculation (PE). The patent protects novel lidocaine-only eutectic formulation which enables maximum absorption of the anesthetic through the skin's outer layer and provides men with improved ejaculatory control while maintaining great sensory feeling.

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ASHP is encouraged by provisions in draft legislation released today by the Senate HELP Committee to address regulatory gaps in the oversight of compounding outsourcers. The draft bill creates a boundary between traditional pharmacy compounding and defines a new entity, “compounding manufacturer.”

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Liver fibrosis results from an excessive accumulation of tough, fibrous scar tissue and occurs in most types of chronic liver diseases. In industrialized countries, the main causes of liver injury leading to fibrosis include chronic hepatitis virus infection, excess alcohol consumption and, increasingly, nonalcoholic steatohepatitis (NASH).

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Immudex has entered into a strategic agreement with the US Cancer Immunotherapy Consortium (CIC) of the Cancer Research Institute, and the European Association for Cancer Immunotherapy (CIMT), under which Immudex will provide MHC-peptide multimer and Elispot proficiency panel services worldwide.

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Researchers have long known that cancerous tumors grow collections of abnormal blood cells, the fuel that feeds this disease and keeps it growing. Now, new evidence in an animal model suggests that blood vessels in the fat tissue of obese individuals could provide the same purpose—and could provide the key to a new way for people to lose weight.

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Although the drug zoledronic acid slows bone loss in osteoporosis patients, it also boosts levels of a biomarker that stops bone formation, according to a recent study accepted for publication in The Endocrine Society’s Journal of Clinical Endocrinology & Metabolism (JCEM).

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Scientists have overcome a major impediment to the development of effective stem cell therapies by studying mice that lack CD47, a protein found on the surface of both healthy and cancer cells. Researchers at the National Cancer Institute discovered that cells obtained from the lungs of CD47-deficient mice, but not from ordinary mice that have the CD47 gene, multiplied in a culture dish and spontaneously converted into stem cells.

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Projected to start in the second half of 2013, researchers at Stony Brook University plan to begin phase IIa placebo-controlled clinical trials using a drug treatment method developed here to treat cellulite. The treatment method is licensed to BioSpecifics Technologies Corp. (“BSTC”), sublicensed to Auxilium Pharmaceuticals, Inc., (“Auxilium”), and uses clostridial collagenase histolyticum (“CCH”), an injectable form of the enzyme collagenase.

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A new procedure that thickens and thins fluid at the micron level could save consumers and manufacturers money, particularly for soap products that depend on certain molecules to effectively deal with grease and dirt. Researchers at the University of Washington published their findings online April 9 in the Proceedings of the National Academy of Sciences.

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• Ibrutinib disrupts the CLL-driving B-cell receptor signaling pathway. • Phase II trial showed the drug was well tolerated and effective against CLL regardless of del 17p status. • The drug was effective against disease in blood, lymph nodes, spleen and bone marrow.

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• Patients received sapacitabine and seliciclib as sequential treatments. • Several patients with BRCA mutations achieved disease response or experienced prolonged stable disease. • BRCA mutation carrier status may be a potential biomarker for response.

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• Women with highest expression of drug’s target protein benefited most. • If further confirmed, drug may represent new treatment option in ovarian cancer. • Future study will compare the drug to standard chemotherapy.

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Physician-researchers at UT Southwestern have identified a vulnerability of certain lung-cancer cells – a specific genetic weakness that can be exploited for new therapies.

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Building upon 30 years of research, Mark Buller, Ph.D., professor of molecular microbiology and immunology at Saint Louis University, studies protecting U.S. armed forces against pox viruses.

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Targeted therapy may prove effective against colon, head/neck, mesothelioma, ovarian and pancreatic cancers.

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Scientists tested the efficacy of cancer drugs at killing the malaria parasite during the liver phase with astonishing success. This research paves the way for future studies using cancer drugs that could cause less drug resistance and have more targeted treatments than conventional malaria drugs.

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For the first time, researchers were able to stimulate immune cells to produce broadly neutralizing antibodies: a critical step that has eluded researchers for decades but that provides promise for a successful HIV vaccine.

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A UCLA study shows that heart failure medications recommended by national guidelines are highly cost effective in saving lives and may also provide savings to the health care system.

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In a laboratory study pairing food chemistry and cancer biology, scientists at the Johns Hopkins Kimmel Cancer Center tested the potentially harmful effect of foods and flavorings on the DNA of cells. They found that liquid smoke flavoring, black and green teas and coffee activated the highest levels of a well-known, cancer-linked gene called p53.

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A type of drug commonly used to treat Type 2 diabetes showed abnormalities in the pancreas, including cell proliferation, that may be associated with an increased risk of neuroendocrine tumors.

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• Ganetespib killed ALK-driven NSCLC cell lines more effectively than crizotinib. • Displayed greater antitumor activity and prolonged survival in a mouse model. • Potential as a new option for treating ALK-dependent lung cancers.

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New insight into the structural nature of Deinococcus manganese complexes in the world’s toughest microbe, Deinococcus radiodurans, gained by using advanced spectroscopy techniques, may ultimately accelerate the development of pharmaceuticals aimed at slowing down the aging process, prevent some severe side effects of radiation therapy and chemotherapy, reduce the chances of skin cancer following exposure to UV rays from the sun, and in the preparation of irradiated vaccines, according to a breakthrough study, “Responses of Mn2+ Speciation in Deinococcus radiodurans and Escherichia coli to Gamma-Radiation by Advanced Paramagnetic Resonance Methods,” published in the March 25 edition of the Proceedings of the National Academy of Sciences USA.

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A Kansas State University-led team is researching ways to stop the spread of norovirus, a contagious stomach illness that infects one in 15 Americans each year.

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University of Missouri researchers believe they have found exactly how Kalydeco (Vx-770), the first drug of its kind to treat the underlying cause of cystic fibrosis, works and how to improve its effectiveness in the future.

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A team led by Sean Ekins at Collaborative Drug Discovery in Burlingame, Cal., and Joel Freundlich at the University of Medicine and Dentistry of New Jersey-New Jersey Medical School has trained computers to sift through drug libraries and pick out compounds likely to clobber TB with minimal side effects to humans. They have ‘taught’ the computers to understand which chemical features of a drug are associated with efficacy against TB and which are associated with toxicity to mammalian cells. The process may lead to much less trial and error in finding new therapies. The computers even rediscovered a compound reported 40 years ago to have anti-TB activity but since forgotten.

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St. Jude Children’s Research Hospital plays key role in research showing that drug shortages erode the quality and increase the cost of cancer care; experts warn that shortages persist despite efforts to fix the problem.

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The Hematology/Oncology Pharmacy Association (HOPA) has released a survey of oncology pharmacists which warns that oncology drug shortages happen often and have serious negative consequences on cancer patients in the in the United States. Published in the April 1, 2013 issue of the American Journal of Health-System Pharmacy, the survey was completed by hematology/oncology pharmacists, who care for cancer patients in all phases of treatment and are uniquely positioned to provide insight on oncology drug shortages.

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Researchers at Moffitt Cancer Center have completed a phase II clinical trial to determine the safety and efficacy of dasatinib for patients with higher-risk myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia, or acute myeloid leukemia resulting from MDS and have failed treatment with azanucleosides. The therapy may not be effective for all patients, but those with trisomy 8 chromosomal disorder have higher rates of stable disease and respond better to treatment with dasatinib, the study shows.

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For some women with breast cancer, taking adjuvant tamoxifen (Nolvadex) for 10 years after primary treatment leads to a greater reduction in breast cancer recurrences and deaths than taking the drug for only 5 years, according to the results of a large international clinical trial.