Advaxis Inc., of North Brunswick, N.J., said it received comments from the FDA regarding its investigational new drug application for Lovaxin C, the company's lead drug candidate, which was filed with a proposed Phase II study for the treatment of cervical intraepithelial neoplasia. The written response letter, received last week, addressed preclinical, manufacturing, microbiologic, immunologic and clinical questions concerning Lovaxin C and its therapeutic use in CIN and cervical cancer caused
Allon Therapeutics Inc., of Vancouver, British Columbia, said results from a 144-patient Phase IIa trial of Alzheimer's disease drug candidate AL-108 demonstrated statistically significant, dose-dependent and durable improvements on endpoints measuring short-term memory recall and working memory. The drug did not affect measures of cognitive functions that are not clinically impaired in patients with amnestic mild cognitive impairment, a precursor of Alzheimer's disease. Data were presented at
Genaera Corp., of Plymouth Meeting, Pa., reported interim Phase I data showing that trodusquemine (MSI-1436), a PTP1B inhibitor, was well tolerated by overweight and obese volunteers with Type II diabetes at anticipated therapeutic dose levels with a very low level of adverse events and no evidence of serious adverse events. Data were presented at the Obesity Drug Development Summit in Arlington, Va. The company also reported preclinical data showing that systemically administered MSI-1436
Alexza Pharmaceuticals Inc., of Mountain View, Calif., said it started a second Phase III study of AZ-004 (Staccato loxapine), an inhalation product for acute agitation in patients with schizophrenia or bipolar disorder. The trial is designed to enroll about 300 patients diagnosed with bipolar I disorder and acute agitation who will be randomized to receive either one of two dose levels, 5 mg or 10 mg, of AZ-004 or placebo. The primary endpoint is the change from baseline in the PANSS (Positive
The Multiple Myeloma Research Consortium has begun a Phase I/II study of elotuzumab (also known as Huluc63), a humanized anti-CS1 monoclonal IgG1 antibody administered intravenously, in combination with Velcase (bortezomib) for Injection for relapsed multiple myeloma. The study, sponsored by PDL BioPharma Inc., of Redwood City, Calif., will evaluate the safety and efficacy of the combination in patients who have received one to three prior therapies.
NeurogesX Inc., of San Mateo, Calif., has begun a Phase I trial (study C203) of NGX-1998, a high-concentration, capsaicin-based liquid formulation designed to deliver a localized therapeutic dose directly to the pain site. The trial is designed to evaluate potential control formulations for future NGX-1998 trials. NeurogesX expects to complete the trial by the end of the year. Nile Therapeutics Inc., of San Francisco, initiated an open-label Phase IIa ascending-dose trial of CD-NP for acute
Additionally, patients receiving Opaxio required fewer clinic visits due to its administration schedule, once every three weeks, and short infusion time, compared with patients who received either gemcitabine or vinorelbine
Adolor Corp., of Exton, Pa., said the FDA has lifted the clinical hold on the investigational new drug application for Entereg (alvimopan) for chronic opioid bowel dysfunction (OBD). While that permits the clinical program to proceed, Adolor said it still is not certain if its partner GlaxoSmithKline, of London, will continue its involvement. Adolor said it understands that GSK is evaluating all options relating to the OBD program, including whether to proceed. A 2002 collaboration between the
Isolagen Inc., of Exton, Pa., said it completed the pivotal efficacy portion of its Phase III studies investigating the Isolagen Therapy for the treatment of nasolabial folds, or wrinkles. The therapy involves multiplication of a patient's own collagen-producing cells, which then are returned to the patient's skin. The company anticipates the top-line efficacy and safety data analyses from the studies to be reported in August. Lorus Therapeutics Inc., of Toronto, said it published the results
Amgen Inc., of Thousand Oaks, Calif., said a new study showed that preemptive skin treatment using skin moisturizer, sunscreen, topical steroids and oral doxycycline halved the incidence of grade 2 and worse skin toxicities in metastatic colorectal cancer patients taking Vectibix (panitumumab) compared to reactive skin treatment. Skin toxicities are a common side effect of epidermal growth factor receptor inhibitors like Vectibix. The data were presented at the 10th World Congress on
Alimera Sciences Inc., of Alpharetta, Ga., reported the interim month-three safety and efficacy results from the first human pharmacokinetic study of Iluvien, an intravitreal insert (Medidur, pSivida Corp.) of fluocinolone acetonide, in patients with diabetic macular edema. The data indicated four of the 20 low-dose patients and three of the 17 high-dose patients showed an improvement in best-corrected visual acuity of 15 letters or greater from baseline. In addition, both doses of Iluvien
Actelion Ltd., of Allschwil, Switzerland, reported data showing that in mildly symptomatic pulmonary arterial hypertension patients with WHO functional Class II PAH, bosentan (Tracleer) prevented clinical deterioration by significantly delaying time to clinical worsening, and it reduced the number of patients worsening to WHO functional Class III/IV disease. A significant reduction in pulmonary vascular resistance and a positive trend in increasing the 6MWD also were observed. Those data were
Aradigm Corp., of Hayward, Calif., said it initiated a Phase II trial of its inhaled liposomal ciprofloxacin, which has been granted orphan drug designation in noncystic fibrosis bronchiectasis in adults. Following an antibiotic wash-out period, 36 patients will be enrolled to receive daily inhaled liposomal ciprofloxacin for 28 consecutive days. The primary endpoint will be the change in the density of Pseudomonas aeruginosa bacterial colony forming units in the sputum over the treatment
Algeta ASA, of Oslo, Norway, started patient recruitment in a pivotal Phase III study of targeted therapeutic Alpharadin in advanced, hormone-refractory prostate cancer (HRPC) that has metastasized to the skeleton. The ALSYMPCA (Alpharadin in SYMptomatic Prostate CAncer) study is expected to enroll about 750 patients to be randomized 2-to-1 to receive Alpharadin plus best standard of care or placebo plus best standard of care. The primary efficacy endpoint is overall survival, while secondary
Aastrom Biosciences Inc., of Ann Arbor, Mich., said it plans to start a 40-patient Phase II trial of its Cardiac Repair Cells, a mixture of stem and progenitor cells derived from a patient's own bone marrow, in dilated cardiomyopathy (DCM), a severe form of chronic heart failure. The technology previously received orphan drug status in that indication. The study will enroll 20 patients each with ischemic DCM and non-ischemic DCM. The primary endpoint is to assess the safety of CRCs, as well as
Adventrx Pharmaceuticals Inc., of San Diego, said overall survival results from its Phase IIb trial of CoFactor in first-line metastatic colorectal cancer have been revised upward slightly. The CoFactor/5-FU (5-fluorouracil) arm demonstrated a 14-day improvement in overall survival compared to the leucovorin/5-FU arm. Last year, the company reported that the drug missed its primary endpoint of reducing serious hematological or gastrointestinal adverse events associated with 5-FU when directly
Altus Pharmaceuticals Inc., of Cambridge, Mass., has completed the last patient visit of the Trizytek Phase III efficacy trial. The trial is evaluating the efficacy of an oral, nonporcine enzyme replacement therapy for cystic fibrosis patients with exocrine pancreatic insufficiency. The company said it is on track to report topline data in the fourth quarter. Amsterdam Molecular Therapeutics, of Amsterdam, the Netherlands, said it concluded enrollment and treated the last patients in a
Javelin Pharmaceuticals Inc., of Cambridge, Mass., dosed the first patient in a pivotal Phase III study of PMI-150 (intranasal ketamine) in acute pain. The trial is expected to enroll about 200 patients and is designed to confirm the drug's analgesic efficacy in postoperative pain following orthopedic surgery. The primary measure of efficacy is the sum of the differences from initial pain intensity as measured on a 1 mm to 100 mm visual analogue scale over six hours. Data from the study are
Achillion Pharmaceuticals Inc., of New Haven, Conn., reported positive safety and efficacy results from its ongoing Phase I trial studying elvucitabine in patients infected with HIV. Elvucitabine is an L-cytosine nucleoside analogue reverse transcriptase inhibitor (NRTI). The results at 48 weeks demonstrated that elvucitabine had a substantial anti-viral effect similar to 3TC, with a mean change in HIV-RNA from baseline in the elvucitabine treatment group of -3.0 log10 (+/-0.55) vs. -3.2 log10
Allos Therapeutics Inc., of Westminster, Colo., presented interim data from its Phase I study of PDX (pralatrexate) with vitamin B12 and folic acid supplementation in patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL), at the International Conference on Malignant Lymphoma in Lugano, Switzerland. Data were presented on 17 patients, including 14 evaluable patients who completed at least one cycle of treatment with PDX at doses ranging from 15 mg/m2 to 30 mg/m2 as part of a
Advaxis Inc., of North Brunswick, N.J., said it received comments from the FDA regarding its investigational new drug application for Lovaxin C, the company's lead drug candidate, which was filed with a proposed Phase II study for the treatment of cervical intraepithelial neoplasia. The written response letter, received last week, addressed preclinical, manufacturing, microbiologic, immunologic and clinical questions concerning Lovaxin C and its therapeutic use in CIN and cervical cancer caused