Elan/Biogen Idec’s Antegren (Natalizumab) for Treatment of Multiple Sclerosis
July 26, 2004 by admin · Leave a Comment
On July 26, 2004 Elan Corp.’s application for approval of its multiple sclerosis (MS) drug Antegren was accepted for review by the FDA. Elan has developed Antegren with U.S. partner Biogen Idec. The company has stated that this therapy represents a new approach in the treatment of MS and is expected to eventually generate annual [...]
ID Biomedical’s FluInsure Influenza Vaccine
July 20, 2004 by admin · Leave a Comment
FluInsure™ On July 20 2004, ID Biomedical released preliminary data regarding FluInsure™ from its field efficacy study. Carried out during the 2003-2004 flu season at 28 sites throughout Canada, this study involved 1,349 healthy participants aged 18 to 64. A single dose of the nasally delivered, non-living vaccine had 67% efficacy (3/451 vs. 9/443 placebo) [...]
Neurochem’s Alzhemed for treatment of Alzheimer’s
July 18, 2004 by admin · Leave a Comment
On July 18, 2004, Neurochem Inc. released interim data pertaining to a Phase II open-label extension study of the effects of Alzhemed on cognitive function and global measure of performance in patients with mild-to-moderate Alzheimer’s Disease. According to Neurochem, the study showed that approximately 70% of the mild AD patients had stabilized or improved cognitive [...]
Nymox Pharmaceutical NX-1207 for BPH
July 14, 2004 by admin · Leave a Comment
On July 14, 2004 Nymox Pharmaceutical Corporation reported FDA approval for the NX-1207 clinical trial protocol for benign prostatic hyperplasia (BPH). In January 2004 the company had reported Phase I results which indicated that safety and tolerability data were sufficient for the company to move NX-1207 into Phase II testing. The recent FDA ruling has [...]
Xenova Group’s TA-NIC for the Treatment of Nicotine Addiction
July 14, 2004 by admin · Leave a Comment
On July 14, 2004 Xenova Group plc released results of a second clinical trial with TA-NIC, a therapeutic vaccine under development for the treatment of nicotine addiction. The company reported that this randomized, placebo controlled, double-blinded study involved a total of 60 smokers and was designed to prove safety and tolerability data while measuring anti-nicotine [...]
Vytorin for the Treatment of Hyperlipidemia
May 14, 2004 by admin · Leave a Comment
Vytorin is a combination therapy comprised of two drugs already separately approved for the treatment of hyperlipidemia. Zocor (simvistatin) and Zetia (ezetimibe) are combined in this oral medication currently awaiting an FDA decision on approval. Results released by Merck and Schering-Plough in March 2004 from Phase III clinical trials demonstrated that patients taking Zocor and [...]
Matritech’s NMP179 for Detection of Cervical Cancer
May 10, 2004 by admin · Leave a Comment
On May 10, 2004 Matritech announced the beginning of clinical testing of 10,000 samples by Sysmex Corporation using NMP179 for the detection of women at risk of or with cervical cancer. The company reported that this novel strategy uses both Sysmex’s flow cytometry technology and Matritech’s NMP179 protein biomarker to perform rapid, cell-by-cell analysis for [...]
Lorus Therapeutics GTI-2040 for Colon Cancer
May 4, 2004 by admin · Leave a Comment
On May 4, 2004 Lorus Therapeutics Inc. reported that it had initiated a clinical trial of GTI-2040 involving patients with advanced unresectable colon cancer. GTI-2040 was administered in combination with FDA approved chemotherapies capecitabine and oxaliplatin. Capectiabine is a first-line therapy while oxaliplatin is approved for use with 5 fluorouracil/ Leucovorin. This study is one [...]
Avanir Pharmaceuticals’ AVP 13358 for Asthma
May 3, 2004 by admin · Leave a Comment
On May 3, 2004 Avanir Pharmaceuticals released results of its Phase I clinical trial with AVP 13358 for asthma. The company reported that this trial, involving 54 healthy volunteers, was designed to demonstrate the safety, tolerability, and pharmacokinetic profile of a single oral administration of AVP 13358. The company indicated that AVP 13358 was well [...]
Amgen’s Enbrel for Psoriasis
April 30, 2004 by admin · Leave a Comment
On April 30, 2004 Amgen Inc. announced that its biological therapy Enbrel® (etanercept) had received approval from the FDA. The drug is approved for the treatment of psoriasis in adult patients who are candidates for systemic therapy and who suffer from chronic moderate-to-severe plaque psoriasis. This most recent approval adds to Enbrel’s previously approved indications [...]