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• Biomira’s subsidiary, Biomira USA, has initiated a Phase Ib clinical research trial to test safety and immunogenicity of an autologous vaccine strategy for the treatment of B-cell lymphoma. This program, carried out under a Collaborative Research and Development Agreement with the U.S. National Cancer Institute, is the second step in the investigation of an autologous vaccine strategy based on a liposomal formulation.
• Novartis has launched NAVIGATOR (Nateglinide And Valsartan in Impaired Glucose Tolerance Outcomes Research), the largest-ever diabetes prevention clinical trial to date. The trial aims to determine whether long-term administration of nateglinide (Starlix) or valsartan (Diovan) reduces or delays the development of Type 2 diabetes and cardiovascular disease (CV) in people who have impaired glucose tolerance (IGT) and who are at high cardiovascular risk. Recent studies suggest that people with IGT are 34% more likely to die from CV disease than people with normal blood glucose control.
• La Jolla Pharmaceutical Co. has filed an Investigational New Drug application with the FDA to begin a Phase I/II clinical trial of LJP 1082, its clinical candidate for the treatment of antibody-mediated thrombosis. The normal regulatory review has been completed, and the company is preparing to begin the clinical study.
• MedImmune has begun dosing psoriasis patients with siplizumab (MEDI-507) in a large Phase II clinical trial. This trial, which is to enroll approximately 400 patients at 50 sites in the United States and Canada, is a part of MedImmune’s development program for siplizumab. By the end of 2001, MedImmune expects to have enrolled approximately 750 patients in seven clinical studies with siplizumab.
• Aventis Behring will initiate a multinational pivotal clinical trial during the first quarter of 2002 for an inhaleable form of Alpha1-Antitrypsin [Human] (AAT) for the treatment of hereditary emphysema. This therapy uses the Inhance pulmonary delivery technology, a proprietary drug delivery solution from Inhale Therapeutic Systems, Aventis Behring’s development partner.
• Immunex Corp. and Wyeth-Ayerst Laboratories have announced that the FDA granted "priority review" status for Immunex’s supplemental Biologics License Application to use etanercept (Enbrel) in the treatment of psoriatic arthritis. Enbrel is the first product reviewed by the FDA to treat the signs and symptoms of psoriatic arthritis.
• Vical has completed enrollment of 200 patients in a randomized, controlled Phase III registration trial to evaluate the safety and efficacy of Allovectin-7 for the treatment of chemotherapy-naive patients with metastatic melanoma. The company chose to complete enrollment at 200 patients based on discussions with the FDA in March 2001.
• Sepracor has announced that (R,R)-formoterol inhalation solution has advanced into Phase III studies for the treatment of bronchospasm in patients with obstructive airway disease. Results of Sepracor’s (R,R)-formoterol Phase II program demonstrated a significant improvement in FEV1 immediately after dosing and a duration of action of up to 24 hours. Currently marketed long-acting beta-agonists require twice-a-day dosing and currently are not available as an inhalation solution.
• Human Genome Sciences has completed patient enrollment in two Phase II clinical trials evaluating mirostipen (Myeloid Progenitor Inhibitory Factor — MPIF) as a treatment for chemotherapy-induced neutropenia and thrombocytopenia. The studies are designed to evaluate the safety, optimal dosing schedule, and preliminary efficacy of mirostipen in this indication.
• NeoTherapeutics’ NeoOncoRx oncology subsidiary will initiate two Phase II studies during the fourth quarter of 2001 of Neotrofin in patients with chemotherapy-induced neuropathy. Both studies will include 50 patients for six months of treatment at the NYU Medical Center. One study will look at Neotrofin’s ability to protect patients from chemotherapy-induced neuropathy, and the second will study the drug’s efficacy in treating neuropathy resulting from chemotherapy.
• Human Genome Sciences has completed enrollment in a Phase IIa clinical trial evaluating repifermin (keratinocyte growth factor-2, KGF-2) as a systemically administered treatment for cancer therapy-induced mucositis. The double-blind, placebo-controlled, dose-escalation Phase IIa human clinical study of repifermin is designed to determine repifermin’s safety, preliminary efficacy, and optimal dosing.
• Atrix Laboratories has submitted a New Drug Application to the FDA for Leuprogel Three-Month Depot, 22.5 mg leuprolide acetate, for the treatment of advanced prostate cancer. Atrix is in late-stage development of three Leuprogel products that release leuprolide acetate over a period of one-, three-, and four-months using Atrix’s Atrigel Depot drug delivery system.
• Genelabs Technologies has initiated a Phase II clinical trial of an investigational new vaccine for prevention of disease caused by hepatitis E virus. The trial is being conducted by the Walter Reed Army Institute of Research in collaboration with the Medical Department of the Royal Nepal Army, the U.S. National Institutes of Health, and Genelabs’ licensee GlaxoSmithKline Biologicals.
• Ribozyme Pharmaceuticals has started the third clinical trial of the antiangiogenic drug Angiozyme in cancer patients. The current study will evaluate Angiozyme as a treatment for cancer patients who currently are taking carboplatin and paclitaxel therapy.
• Forest Laboratories has submitted a New Drug Application with the FDA to market lercanidipine for the treatment of hypertension. Lercanidipine is a member of the dihydropyridine calcium channel blocker class of drugs.
• Nastech Pharmaceutical Co. has commenced a Phase I clinical trial in the United States to evaluate the nasal administration of somatropin (recombinant human growth hormone, or rhGH). The objective of the Phase I study is to determine nasal absorption, tolerance, and safety of somatropin in healthy volunteers. Somatropin is indicated for the long-term treatment of children with growth failure due to lack of adequate endogenous growth hormone secretion.
• Genmab A/S has initiated a Phase I/II clinical trial with its fully human antibody HuMax(TM)-IL15 to treat patients with active rheumatoid arthritis. This multi-center, placebo-controlled study will test up to six dose levels and include approximately 30 patients. It is designed to provide safety data about both single and multiple doses of HuMax-IL15, with a secondary goal of gathering information about the efficacy of the antibody.
• Ribozyme Pharmaceuticals has begun a multicenter Phase II clinical trial using Heptazyme for the treatment of patients with chronic hepatitis C. The study is designed to evaluate Heptazyme safety and efficacy when administered alone and in combination with interferon.
• Texas Biotechnology Corp. has announced that its marketing partner, GlaxoSmithKline (GSK), has initiated a Phase II trial evaluating Argatroban as a treatment for patients undergoing percutaneous coronary interventions. The 100-patient, open-label clinical trial is designed to assess the safety and efficacy of Argatroban as an alternative to heparin in patients undergoing PCI and in combination with GPIIb/IIIa receptor antagonists.
• Nastech Pharmaceutical Co. has commenced enrollment in a Phase II clinical trial in the United States to evaluate the efficacy and safety of a patent-protected nasal formulation of morphine gluconate for the treatment of breakthrough pain in opioid-tolerant cancer patients. A total of 20 qualified cancer patients will receive the study medication as part of an open-label, single-site study.
• Hollis-Eden Pharmaceuticals has received approval to initiate a Phase II clinical trial in Hepatitis B-infected patients with the company’s lead investigational drug, HE2000, at Mt. Elizabeth Medical Centre in Singapore. The clinical study will evaluate the safety, tolerance, and clinical and biological effects of HE2000, an immune regulating hormone, in young chronic HBV-infected patients.
• AtheroGenics has announced that it has begun a Phase I clinical trial with AGIX-4207 IV as an intravenous treatment for people with rheumatoid arthritis. The trial is designed to assess the safety and tolerability of AGIX-4207 IV in healthy volunteers.