Adventrx Pharmaceuticals Inc., of San Diego, completed enrollment of a targeted 32 patients in its single-arm, Phase II trial of ANX-510 (CoFactor) plus 5-fluorouracil (5-FU) for breast cancer. CoFactor is the active metabolite of leucovorin and is intended to boost the efficacy and decrease the toxicity of 5-FU. Data are expected in the second quarter of 2008. A Phase IIb trial in colorectal cancer missed its primary endpoint earlier this year, and a Phase III colorectal cancer trial with 5-FU
Acorda Therapeutics Inc., of Hawthorne, N.Y., completed enrollment in its Phase III trial of Fampridine-SR in multiple sclerosis. That 240-patient trial is designed to evaluate the drug's efficacy in improving walking ability. Data are expected in the second quarter of 2008. Alpharma Inc., of Bridgewater, N.J., reported positive results from its 500-patient, pivotal Phase III trial of ALO-01, an abuse-deterrent, extended-release opioid, which demonstrated significant pain relief, meeting the
4SC AG, of Planegg-Martinsried, Germany, reported results from its Phase IIa study of SC12267 in rheumatoid arthritis, which showed that the drug was safe and well tolerated. Data also confirmed dose-dependent trends in efficacy, in accordance with ACR20 responses (a measure for the reduction of RA symptoms of at least 20 percent). About 47 percent of patients in the 35-mg dose group showed an ACR20 response compared to 33 percent in the placebo group. The company said data also indicated a
Barrier Therapeutics Inc., of Princeton, N.J., announced positive results of a safety, dose escalation study with its oral antifungal agent pramiconazole. No clinically relevant changes were seen in any of the 32 healthy volunteers dosed with up to 6 g of pramiconazole given over a five-day period, as compared to placebo. The study measured cardiac parameters, including QT/QTc interval, liver and kidney function, and several other blood chemistry parameters. The total of 6 g administered over
Cell Therapeutics Inc., of Seattle, said its wholly-owned subsidiary, Systems Medicine LLC, revealed preliminary data from a Phase I trial combining brostallicin with cisplatin in solid tumors. Of the first 21 patients treated in the Phase I dose-escalation trial, 14 experienced stable disease and half of those 14 patients had durable stable disease for more than six cycles of therapy. Phase II trials are planned combining Brostallicin, a synthetic, second-generation DNA minor groove binder
BioAlliance Pharma SA, of Paris, has completed patient enrollment in the pivotal Phase III trial for Loramyc for the treatment of oropharyngeal candidiasis. The trial will include 540 patients enrolled by 40 specialist clinical centers in the U.S., Canada and South Africa. The trial results are expected in the first half of 2008. The company plans to file a market authorization application in the second half of next year, subject to the FDA's regulatory requirements. Peregrine Pharmaceuticals
Allos Therapeutics Inc., of Westminster, Colo., initiated patient enrollment in a Phase I trial of its targeted chemotherapeutic agent RH1 in patients with advanced solid tumors or non-Hodgkin's lymphoma. In the dose-escalation study, up to 60 patients will receive a three-hour intravenous infusion of RH1 administered once every 21 days. Archemix Corp., of Cambridge, Mass., started a Phase IIa trial of ARC1779, which is designed to test the drug's safety and efficacy as an anti-thrombotic in
Akesis Pharmaceuticals Inc., of San Diego, said the FDA accepted its investigational new drug application for AKP-020, a vanadium compound, in Type II diabetes. Screening already has begun for patients in a Phase IIa trial measuring the drug's efficacy using the euglycemic-hyperinsulinemic clamping procedure. The company expects to dose the first patient before the end of the year. AtheroGenics Inc., of Atlanta, said it stopped testing the highest dose of AGI-1067 (300 mg) in its ongoing
Cougar Biotechnology Inc., of Los Angeles, said results from an ongoing Phase II trial of CB7630 (abiraterone acetate) in patients with advanced prostate cancer who have failed docetaxel-based chemotherapy show that the drug is well tolerated with only minimal toxicity in the 10 patients treated so far. Four of those patients (40 percent) experienced a confirmed decline in prostate-specific antigen levels of greater than 50 percent, and, of the five evaluable patients with measurable tumor
Clinic Roundup, page 2.) Isis has since moved on to second-generation antisense drugs, and Berkeley Heights, N.J.-based Genta continues to hold out hope for Genasense, having recently appealed an FDA non-approvable letter in CLL and initiated a new, biomarker-specific Phase III study in melanoma
By Jennifer Boggs | BioWorld Today | Friday, November 9, 2007
AVEO Pharmaceuticals Inc., of Cambridge, Mass., said data from an expanded Phase I trial of the triple VEGF inhibitor AV-951 demonstrated that all nine patients with refractory renal cell carcinoma achieved a partial response or stable disease after treatment. The company initiated a 200-patient, placebo-controlled Phase II trial of the drug in metastatic renal cell carcinoma with co-primary endpoints of objective response rate and progression-free survival. Banyan Biomarkers Inc., of
Emergent BioSolutions Inc., of Rockville, Md., completed a human study to support the expansion of BioThrax (anthrax vaccine absorbed) in post-exposure prophylaxis in people exposed to anthrax. The company also submitted a final study report for that trial to the Department of Health and Human Services, which triggers an $8.8 million payment under the company's $448 million HHS contract signed in September. (See BioWorld Today, Sept. 27, 2007.) Epeius Biotechnologies Corp., of San Marino
Adventrx Pharmaceuticals Inc., of San Diego, said it will stop enrolling patients in its Phase III trial of CoFactor in first-line treatment metastatic colorectal cancer, upon advice from its data safety monitoring board, which cited a slow accrual rate and the fact that analysis of Phase IIb data showed no significant differences between the treatment arm and control arm with regard to either safety or efficacy. Results of the Phase IIb trial, reported last month, showed that CoFactor missed
Adolor Corp., of Exton, Pa., started a second Phase II study of ADL5859, a delta opioid agonist in development for pain. The study, designated 33CL232, is expected to enroll about 60 subjects and will explore the analgesic efficacy of the drug in treating inflammatory pain associated with rheumatoid arthritis. ADL5859 also is being tested in an acute pain study, which began in the second quarter, and the company anticipates a third trial in neuropathic pain to start later this year. Avicena
Achillion Pharmaceuticals Inc., of New Haven, Conn., announced preliminary 12-week results from an ongoing Phase II trial studying elvucitabine in patients infected with wild-type HIV. The results at 12 weeks demonstrated potent antiviral activity similar to 3TC, with a mean change in HIV-RNA from baseline in the elvucitabine group of -2.7 log10 (+/-0.82) vs. -3.0 log10 (+/-0.79) in the 3TC group. In addition, elvucitabine was well tolerated, with no serious drug-related adverse events. Full
The compound is partnered with Bayer AG, of Leverkusen, Germany. (See Clinic Roundup, page 8.) Biogen, though, has more in its pipeline that could make the firm more tantalizing, including 15 programs that have reached or surpassed Phase II trials
By Randall Osborne | BioWorld Today | Tuesday, October 16, 2007
Affymax Inc., of Palo Alto, Calif., and Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, said Affymax has dosed the first patient in the Phase III clinical program of its lead investigational therapy Hematide for anemia in chronic renal failure patients. The Hematide Phase III program, involving about 2,200 chronic renal failure patients, consists of four open-label, randomized-controlled clinical trials in the U.S. and Europe, including two trials in patients on dialysis and two trials in
Barrier Therapeutics Inc., of Princeton, N.J., completed patient enrollment for its pivotal Phase III study of Hyphanox, an oral formulation of the antifungal agent itraconazole, in toenail onychomycosis. The trial is designed to compare the efficacy of once-daily dosing of one 200-mg tablet of Hyphanox to two 100-mg capsules of generic itraconazole for three months, with efficacy defined as both complete clinical and mycological cure of the toenail fungal infection at nine months following end
Acceleron Pharma Inc., of Cambridge, Mass., reported positive results from a Phase I trial of ACE-011, a bone-forming agent, which showed that the drug was well tolerated, with no serious adverse events, and that the pharmacokinetic properties showed a linear profile with dose and a mean half-life of about 24 to 32 days. A single dose of ACE-011 caused a rapid, sustained, dose-dependent increase of up to 35 percent in serum levels of the marker of bone formation, bone-specific alkaline
Adventrx Pharmaceuticals Inc., of San Diego, completed enrollment of a targeted 32 patients in its single-arm, Phase II trial of ANX-510 (CoFactor) plus 5-fluorouracil (5-FU) for breast cancer. CoFactor is the active metabolite of leucovorin and is intended to boost the efficacy and decrease the toxicity of 5-FU. Data are expected in the second quarter of 2008. A Phase IIb trial in colorectal cancer missed its primary endpoint earlier this year, and a Phase III colorectal cancer trial with 5-FU