Making Sense of Clinical Trials: A Guide for BioHorizon Clients

BioHorizon’s five step guide to interpreting clinical trial results helps patients, physicians, executives, and investors make informed decisions about new medical technologies.

OSI Pharmaceuticals and Genentech’s Tarceva Non-Small Cell Lung Cancer Therapy

On November 18, 2004 OSI Pharmaceuticals and Genentech, Inc. announced that the FDA had approved their cancer therapeutic Tarceva™ (erlotinib). The oral tablet is intended for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen. The FDA’s approval of Tarceva was based on results [...]

Nabi Biopharmaceuticals Altastaph for the Prevention and Treatment of Staph. Aureus Infections

On Nov 17, 2004 Nabi Biopharmaceuticals released results from its Phase 2 clinical trial of Altastaph in premature or very low birth weight infants (infants weighing between 500 and 1500 grams). The company indicated that while the primary end-points of the study were met, an unexpectedly low rate of S. aureus infections in both the [...]

Abbott Labs ABT-874 for Treatment of Crohn’s Disease

On November 11, 2004 the results of an Abbott Labs Phase 2 Crohn’s disease clinical trial examining the safety and efficacy of ABT-874 were published in the New England Journal of Medicine. , ABT-874 is a monoclonal antibody designed to target interleukin-12 (IL-12). The authors concluded that treatment with ABT-874 may have caused clinical responses [...]

Nitromed’s BiDil Combination Therapy for Congestive Heart Failure

On November 8, 2004 Nitromed reported that the data from its Phase 3 A-HeFT trial would be published in the New England Journal of Medicine and presented at the American Heart Association’s Late Breaking Scientific Sessions. This randomized, placebo-controlled, double blind clinical trial enlisted 1050 African American patients with New York Heart Association class III [...]

Sanofi-Synthelabo’s Eloxatin for Postsurgical Treatment of Stage III Colon Cancer

On November 5, 2004 Sanofi-Synthelabo’s Eloxatin™ (oxaliplatin for injection) received US FDA approval for use in combination with conventional chemotherapy (5-flurouracil and leukovorin) for the postsurgical treatment of stage III colon cancer patients. According to the company, this is the first new chemotherapy approval for the adjuvant treatment of colon cancer in over a decade. [...]

MedImmune’s CAIV-T Influenza Vaccine

On November 1, 2004 MedImmune announced that enrollment in its Phase 3 CAIV-T influenza vaccine trial had been completed. This pivotal trial is designed to compare the company’s nasally administered cold-adapted vaccine to the standard injectable vaccine in 8,492 children between 6 and 59 months of age. CAIV-T is refrigerator stable and is regarded by [...]

DePuy Spine’s Charite Artificial Disc for Replacement of Spinal Discs

On October 26, 2004 DePuy Spine Inc. announced that the FDA had approved the Charite™ Artificial Disc. The Charite Artificial Disc, a device made of two metallic endplates and a movable high-density plastic center, is the first FDA approved artificial replacement for spinal discs. The standard surgical intervention for this indication is lumbar fusion surgery [...]

Eli Lilly and Sankyo’s CS-747 / Prasugrel for Acute Coronary Syndrome

On October 25, 2004 Eli Lilly and Company and Sankyo Company announced that a Phase 3 clinical trial comparing the antiplatelet agents prasugrel and Plavix™ is scheduled to begin later this year. The study, known as TRITON-TIMI 38, will include a reported 13,000 patients who are suffering acute coronary syndromes (heart attacks or unstable angina) [...]

Wyeth’s Enbrel for treatment of Psoriasis

On July 30, 2004 Wyeth reported that a European Commission panel had recommended that regulators approve Enbrel as a treatment for psoriasis after other treatments were found inadequate or inappropriate. The Committee for Medicinal Products for Human Use will report its findings to the European Commission for endorsement before Enbrel can receive marketing approval. Wyeth [...]

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