OncoGenex starts phase-3 trial of lung cancer drug
BOTHELL, Wash. — Drug maker OncoGenex Pharmaceuticals has started its third late-stage clinical trial of a drug for treating a type of lung cancer.
OncoGenex announced Friday the initiation of the phase-3 "ENSPIRIT" trial of custirsen in patients with nonsmall cell lung cancer that has spread to other parts of the body, also known as metastasis, and whose disease has progressed after initial treatment with chemotherapy has failed.
The trial, which will enroll about 1,100 patients, will combine custirsen with docetaxel, a common second-line chemotherapy drug in NSCLC.
"Despite breakthroughs in molecular targeting for advanced NSCLC, most patients require chemotherapy, and unfortunately, often progress to require second-line treatment," OncoGenex EVP and chief medical officer Cindy Jacobs said. "Given custirsen’s enhancement of taxanes pre-clinically as well as with a wide range of anti-cancer agents, even in chemo-resistant models, we are eager to learn if custirsen can improve docetaxel outcomes in patients with progressive NSCLC."
The company is conducting two other phase-3 studies: "SYNERGY," which will evaluate custirsen in patients with castrate-resistant prostate cancer receiving first-line docetaxel chemotherapy; and "AFFINITY," which will investigate the drug combined with Sanofi’s second-line chemotherapy drug Jevtana (cabazitaxel) in patients with CRPC.
FDA approves two generic hypertension drugs from Mylan
PITTSBURGH — Generic drug maker Mylan has received regulatory approval for a drug used to treat high blood pressure, also known as hypertension, the company said Friday, saying that it would launch both drugs immediately.
Mylan said the Food and Drug Administration approved its irbesartan tablets in the 75 mg, 150 mg and 300 mg strengths and irbesartan and hydrochlorothiazide tablets in the 150 mg/12.5 mg and 300 mg/12.5 mg strengths. The drugs are respectively generic versions of Sanofi’s Avapro and Avalide.
Avapro is used to treat hypertension in patients with Type 2 diabetic nephropathy, while Avalide is used to treat hypertension in patents whose disease is inadequately controlled with a single drug or who are first starting therapy and need multiple drugs to control blood pressure.
Irbesartan tablets had sales of about $400.7 million during the 12-month period ending in June 2012, while irbesartan and hydrochlorothiazide tablets had sales of about $117.4 million during the same time, according to IMS Health.
Energizer introduces safe, flameless candles
ST. LOUIS — Energizer Household Lighting has introduced an innovative option for those wanting the ambiance of candles without the worry of open flames: Energizer Flameless Wax Candles.
The Flameless Wax Candles, currently available online and at mass market retailers, feature a realistic flickering LED “flame” and melted edge design at the top of the candle. A three-level timer allows the user to schedule the candle to turn off after four, six or eight hours of use; the candle also can be programmed to turn on at the same time every day.
In addition to a year-round selection of Flameless Wax Candles in various colors and designs, Energizer created a special holiday collection featuring fragrant scents, snowflake and floral designs, “JOY” votives, and red or white glitter pillars. The candles retail for $4.99 to $23.99.