In the Pipeline
In the Pipeline
The following drugs are still in clinical trials:
- Pediatric combination vaccine Infanrix (DTPa HepB-IPV) by SmithKlineBeecham. The company has submitted a Biologics License Application to the FDA and is seeking priority review status for the vaccine, developed as a three-shot combination regimen against diphtheria, tetanus, pertussis, hepatitis B, and polio, to replace current nine-shot regimens. The application was submitted following clinical trials in which the company says more than 20,000 doses were administered to study safety and efficacy.
- Antifungal AmBisome (amphotericin Bliposome for injection) by Fujisawa Healthcare. The company has submitted a supplemental New Drug Application, seeking approval for use in the treatment of cryptococcal meningitis in AIDS patients as the first lipid agent granted a first-line treatment indication for the infection. Cryptococcal meningitis commonly occurs in the brains of 5% to 10% of AIDS patients after exposure to fungus Cryptococcus neoformans. The submission follows phase III trials of 267 AIDS patients; detailed results have been submitted for publication to the Sept. 26-29 meeting of the Interscience Conference on Antimicrobial Agents and Chemotherapy in San Francisco.
- Advanced small-cell lung cancer treatment squalamine (angiogenesis inhibitor) by Magainin Pharmaceuticals. Part of the new classes of synthetically produced or naturally occurring inhibitors known as the angiogenesis class, the drug inhibits tumors by cutting off blood vessel growth within tumor cells. Magainin’s squalamine is among the naturally occurring aminosterols molecule class and is being studied in Phase II trials in combination with paclitaxel and carboplatin. In pre-clinical models of human tumors transplanted into animals, reduction in the growth of lung, breast, prostate and brain tumors have been achieved, according to the company.
- Irritable Bowel Syndrome (IBS) treatment Lotronex (alosetron hydrochloride) by Glaxo Wellcome. A New Drug Application has been submitted for the drug following the completion of Phase III placebo-controlled trials of 1,250 female patients resulting in significant relief after one to four weeks, which was maintained over a 12-week period. In this country, 70% of IBS patients are women. Glaxo reported the initiation of trials on men for the chronic condition earlier this summer.
- Investigational colorectal cancer treatment NV1020 by NeuroVir Therapeutics. The company has submitted an Investigational New Drug Application for the genetically engineered herpes simplex virus as a tumor-reducing agent, seeking approval to begin Phase I/II trials. The submission included data specific to the treatment of colorectal cancer that has metastasized to the liver, carried out at the Sloan Kettering Cancer Center in New York City. The data included research on the investigational drug’s activity in combination with the colorectal chemotherapy treatment 5-Fluorouracil.
- Hyperphosphatemia treatment Lambda (lanthanum carbonate) by AnorMED Inc. Phase III trials have begun, aimed at lowering blood phosphate levels in patients with chronic kidney failure. If untreated, hyperphosphatemia leads to the osteoporosis-related condition osteodystrophy in kidney failure patients, who currently take phosphate binders to prevent absorption in the bloodstream. Lambda is indicated with food to similarly form an insoluble phosphate salt, passed by the body to prevent bloodstream absorption. In a six-week Phase II trial, serum phosphate was reduced by 0.95 mg/dl at 1350 mg doses, and by 1.13 mg/dl with 2250 mg doses.
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