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Genentech said that the U.S. Food and Drug Administration granted accelerated approval for Avastin, in combination with paclitaxel chemotherapy, for the treatment of patients who have not received chemotherapy for their metastatic HER2-negative breast cancer. The approval is based on a late-stage clinical study that showed that Avastin in combination with paclitaxel chemotherapy resulted in a 52 percent reduction in the risk of disease progression or death compared to those treated with paclitaxel alone and a doubling in progression-free survival. No new safety signals were observed, the company said. Avastin was approved in advanced breast cancer under the FDA’s accelerated approval program, which allows the FDA to approve products for cancer or other life-threatening diseases based on initial positive clinical data. Genentech has shared with the FDA a summary of the results from a second positive late-stage clinical trial, and is expecting results from a third in first-line metastatic breast cancer in late 2008.

 

Combined hormone therapy appears to increase the risk that women will have abnormal mammograms and breast biopsies, and it may decrease the effectiveness of both methods for detecting breast cancer, according to a report in the Archives of Internal Medicine.

Researchers at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center studied 16,608 post-menopausal women who participated in the Women’s Health Initiative clinical trial, a 15-year study that began in 1993. The research team examined the effect of combined hormone therapy on breast cancer detection over five years and found it resulted in more than one in 10 women having otherwise avoidable mammogram abnormalities and one in 25 women having breast biopsies. Combined hormone therapy also compromised the diagnostic performance of mammograms and breast biopsies. The researchers said their findings represent a concern for post-menopausal women who are considering hormone therapy and that they should consult with their physicians before undergoing even short-term hormone therapy.

In a research report published in The FASEB Journal researchers from the University of California at Davis show that hydrogen peroxide (or similar oxidants) in cigarette smoke is responsible for turning healthy lungs cancerous. This finding may help the tobacco industry develop “safer” cigarettes by eliminating such substances, while giving medical researchers a new avenue to developing lung cancer treatments. According to the U.S. Centers for Disease Control and Prevention, cigarette smoking is the single most preventable cause of premature death in the United States, resulting in more than 400,000 deaths per year, or about 1 in 5 U.S. deaths overall. Smoking accounts for the vast majority of lung cancer deaths, causing 90 percent of all lung cancer deaths in men and about 80 percent in women.

 

An experimental anti-HIV gel is safe for women to use on a daily basis, according to researchers at the University of Alabama at Birmingham and the University of Pittsburgh School of Medicine. Testing of the self-applied gel called tenofovir show it was tolerable to non-HIV-infected women. Researchers said it could be a significant boost to HIV and AIDS prevention efforts focused on next-generation microbicides to reduce infection rates. Researchers evaluated if tenofovir was safe to use every day for six months, or safe to use prior to each act of intercourse. They found both approaches equally safe. Women in the study were asked to use condoms in addition to the gel. The study participants said if tenofovir gel is approved for the prevention of HIV infection, they would be willing to apply the gel to themselves daily or before sex, whichever is determined the best use. The active ingredient in tenofovir gel is a class of anti-retroviral drugs called nucleotide reverse transcriptase inhibitors, which act against HIV by blocking the virus’ ability to replicate and grow inside the body.

 

ANTIBODIES: GENENTECH PLANS TO APPEAL REJECTION OF KEY PATENT IF DECISION IS MAINTAINED

South San Francisco-based Genentech said it plans to appeal a decision by the U.S. Patent and Trademark Office to reject the patentability of a key patent around its antibody technology if the decision is maintained after the company files a repsonse. The patent, known as the Cabilly patent, relates to certain methods used to make antibodies and antibody fragments by recombinant DNA technology, as well as recombinant cells and DNA that are used in those methods. The patent remains valid and enforceable through the appeals process. The company estimates that the entire appeals process may take approximately one to two years, or longer.

 

CLINICAL TRIALS SIMULATION: PDL BIOPHARMA ENTERS AGREEMENT WITH ENTELOS
Foster City, California-based Entelos said that Redwood City, California-based PDL Biopharma signed an agreement with Entelos to conduct in silico research and “virtual clinical trials.” The research is expected to take two months and is focused on identifying primary endpoints, patient types, and optimal doses to support one of PDL’s antibody development programs. Entelos said simulating clinical trials prior to conducting them can significantly reduce the risk, time, and overall cost of a drug program, especially when companies are faced with key decisions about selecting the right dose and patient types upfront.

 

TRAUMATIC BRAIN INJURY: DOD AWARDS GRANT TO SYNTHETIC BLOOD INTERNATIONAL FOR OXCYTE TRIAL
The U.S. Department of Defense has awarded a $1.9-million grant to Costa Mesa, California-based Synthetic Blood International to conduct a mid-stage clinical trial with the University of Miami Miller School of Medicine of Oxycyte for the treatment of traumatic brain injury. Oxycyte is the company’s perfluorocarbon therapeutic oxygen carrier and blood substitute. The company said the grant will permit it to double its planned enrollment for the trial to 200 patients. Synthetic Blood expects to begin the trial in April. About 12,000 U.S. and allied troops have been injured in fighting in Iraq and Afghanistan, and severe traumatic brain injury has been termed “the signature injury” in this conflict. It is the largest cause of death and severe disability among persons under the age of 40 in the United States as well as worldwide. Most TBI victims die or remain severely disabled due to inadequate early cerebral oxygenation or perfusion.

 

Althea Technologies said it has spun-out an independent company to commercialize its breakthrough genetic testing technology for use in monitoring and managing cancer treatment. Althea Diagnostics will build upon commercialized proprietary technology for quantitative measurement of multiple genes in a single reaction, as well as new technologies and bioinformatics applications designed to speed development of molecular diagnostic tests. The company will be located within Althea's San Diego campus. The Althea Diagnostics spin-out incorporates a test for differential diagnosis of pediatric solid-tumors, along with a pipeline of other biomarker sets that will be used for cancer management. In addition, the company will continue to provide laboratory services for biopharmaceutical companies and contract research organizations.

RLS: GSK AND XENOPOT SAID LATE-STAGE TRIAL MEETS MAIN GOAL

Santa Clara, California-based XenoPort and GlaxoSmithKline reported positive top-line results from the final, pivotal late-stage clinical trial of XP13512 for the treatment of moderate-to-severe symptoms of primary restless legs syndrome, or RLS. Up to 12 million people suffer from RLS—disturbing, unpleasant, and sometimes painful sensations in the legs that result in a compelling urge to move. Because symptoms typically occur at night, RLS patients often suffer from sleep disruption. XP13512 demonstrated statistically significant improvements compared to placebo on both of the co-primary endpoints of the trial and was generally well-tolerated. The drug is the first non-dopaminergic agent to demonstrate efficacy in controlled clinical trials for the treatment of primary RLS and may offer patients a new treatment option, the companies said. They expect to file an application in the third quarter with the U.S. Food and Drug Administration to begin marketing the drug.

 

WOMEN’S HEALTH: ONE IN THREE WOMEN SUFFER FROM ONE OR MORE PELVIC FLOOR DISORDERS
A study by Kaiser Permanente found that one-third of women suffer from one or more pelvic floor disorders, which include symptoms such as the frequent urge to urinate, dropped pelvic organs, and incontinence. The study involved the broadest age range of participants to date, 25 to 84, of which 80 percent of the 4,000 women had given birth. Of those 4,000 women, 25 percent suffered from anal incontinence, 15 percent from stress urinary incontinence, 13 percent from overactive bladder, and 6 percent experienced pelvic organ prolapse, the dropping of pelvic organs. The study, published in the journal Obstetrics & Gynecology, surveyed women in English and Spanish, making it the most extensive research on the subject to date across such a wide age range. Funded by the National Institutes of Health, the findings expand on research published two years ago by the same scientific team from Kaiser Permanente Southern California and the University of California, San Diego Medical Center that found that women who had experienced vaginal births had double the rate of pelvic floor disorders compared to women who had Cesarean deliveries and women who have never given birth. More than 15 million women in the U.S. have stress urinary incontinence and 16 million women have an overactive bladder. One in 10 women suffers from anal incontinence, with one in 15 experiencing moderate to severe symptoms. Over a woman’s lifetime, 11 percent are likely to have pelvic surgery for urinary incontinence and/or prolapse while 29 percent will have multiple surgeries for pelvic floor disorders, according to previous studies published in Neurological Urodynamics and Urology.

 

Differences in gene expression levels between people of European versus African ancestry can affect how each group responds to certain drugs or fights off specific infections, researchers from the University of Chicago Medical Center and the Expression Research Laboratory at Affymetrix of Santa Clara, California report. In a study published in the of online edition of the American Journal of Human Genetics, the researchers found that expression levels for nearly five percent of the 9,156 human genes they studied varied significantly between individuals of European and African ancestry. The research team took an unbiased whole genome approach and found significant differences in several unrelated processes, especially among genes involved in producing antibodies to potential microbial invaders. Understanding at the genetic level how individuals within and among populations vary in their response to drugs could improve treatment, the researchers said.

Rancho Cordova, California-based ThermoGenesis said that its wholly-owned subsidiary, Vantus, has signed a formal agreement with the UC Davis School of Veterinary Medicine's Center for Equine Health and its Stem Cell Regenerative Medicine Group. Under the agreement, the organizations will conduct joint research and development of methods to enhance the collecting, processing, and storing of stem cells from equine cord blood, bone marrow, and placental tissue. These cells will be used in the development of therapeutics for the prevention and treatment of orthopedic injuries, such as tendon and ligament injuries, in performance horses. Earlier this month, ThermoGenesis created Vantus, a laboratory service company focused on the performance equine market, including Thoroughbreds, American Quarter Horses, Arabians, and Warm Bloods.