Alfacell Corp., of Bloomfield, N.J., reached the full target enrollment of 316 patients in its international, confirmatory Phase IIIb registration trial evaluating Onconase (ranpirnase) to treat unresectable malignant mesothelioma (UMM). Onconase is being evaluated at more than 40 sites across 10 countries in a centrally randomized, open-label Phase IIIb trial as a treatment for UMM, an asbestos-related cancer that afflicts 10,000 people worldwide.
Algeta ASA, of Oslo, Norway, said an analysis of the biomarker data from a Phase II trial of its lead product Alpharadin (radium-223) continues to demonstrate its potential as a treatment for bone metastases in hormone-refractory prostate cancer patients (HRPC). Data from the trial, which showed that repeated doses of Alpharadin resulted in minimal bone marrow suppression, were presented at the 2006 Prostate Cancer Symposium in San Francisco. The double-blind, placebo-controlled trial involves 64 patients with painful skeletal metastases as a consequence of HRPC and is in its follow-up phase at 11 centers in Norway, Sweden and the UK.
Cell Genesys Inc., of South San Francisco, said its second multicenter Phase II trial of GVAX immunotherapy for prostate cancer indicated estimated median survival will be no less than 29.1 months. An analysis of survival data for the companys two Phase II trials of GVAX showed a favorable comparison of observed to predicted median survival for both studies. The data were reported at the 2006 American Society of Clinical Oncology Prostate Cancer Symposium in San Francisco.
ConjuChem Inc., of Montreal, said the FDA cleared its Phase I/II protocol to treat Type II diabetes using the companys PC-DAC:Exendin-4 compound. The protocol also was approved by an independent institutional review board. Patient dosing will begin in mid-March, and preliminary data is expected in the middle of the year. The study will enroll 68 patients and will consist of six cohorts and a maximum tolerated dose group.
Genitope Corp., of Redwood City, Calif., began a Phase I/II trial to evaluate the use of MyVax personalized immunotherapy to treat chronic lymphocytic leukemia. Nine North American cancer centers will begin registering about 70 previously untreated patients who are 18 or older. MyVax personalized immunotherapy is based on the unique genetic makeup of a patients own tumor, and is designed to activate the patients immune system to fight cancer, so each person will receive a series of 16 injections of his or her custom-made immunotherapy over the course of a year.
GPC Biotech AG, of Munich, Germany, and Spectrum Pharmaceuticals Inc., of Irvine, Calif., said new clinical and preclinical data reported at the ASCO Prostate Cancer Symposium in San Francisco detailed satraplatins multiple uses. Findings in a clinical poster showed evidence of satraplatins antitumor activity in a heavily pre-treated group of 17 patients that included seven with hormone-refractory prostate cancer. One patient had a partial response, and two had prolonged stable disease lasting 3.5 months and five months. Also, in vivo and in vitro data showed that satraplatin and its active metabolite, JM-118, inhibited the growth of prostate cancer cells in a dose-dependent fashion. In addition, when satraplatin or JM-118 was combined in vitro with Taxotere, a synergistic effect was demonstrated in prostate cancer cells. The effect was strongest when Taxotere was followed by JM-118.
MediciNova Inc., of San Diego, completed enrollment in its Phase II/III trial of MN-305 in 416 patients with generalized anxiety disorder. Results from the trial begun in December 2004 are expected by the end of the second quarter. The patients have been randomized to receive placebo or one of two flexible dose regimens of MN-305 at 25 clinical sites in the U.S.
NPS Pharmaceuticals Inc., of Salt Lake City, said results of a Phase IIa proof-of-concept study of teduglutide in patients with moderate to severe Crohns disease showed a positive and consistent trend toward efficacy, and a dose response favoring the highest dose group. The drug also was well tolerated with no serious adverse events reported related to the drug. Teduglutide is an analog of glucagon-like peptide 2, a hormone that regulates the growth, proliferation and maintenance of cells lining the gastrointestinal tract.
Nuvelo Inc., of San Carlos, Calif., began patient enrollment in a second pivotal Phase III trial of its lead product candidate, alfimeprase, in the treatment of central venous catheter occlusion (CO). The trial, known as SONOMA-3 (Speedy Opening of Non-functional and Occluded catheters with Mini-dose Alfimeprase-3) is the second of two overlapping trials in CO, and will evaluate the safety and efficacy of 3 mg of alfimeprase in 800 patients with occluded central venous catheters. The company also is testing the drug, a direct-acting thrombolytic, in two ongoing Phase III trials in patients with acute peripheral arterial occlusion.
Peregrine Pharmaceuticals Inc., of Tustin, Calif., said top-line data reported at the Strategic Research Institutes Viral Hepatitis in Drug Discovery and Development conference in Boston demonstrated that its first-in-class antiviral compound, Tarvacin, appeared safe and well-tolerated in a Phase l study in 24 chronic hepatitis C virus patients. In the ascending, single-dose trial, there were no serious adverse events reported at any of the four dose levels tested, and no potential dose limiting toxicities were observed. The data will support repeat-dose and combination therapy trials that the company expects to begin later this year.
TorreyPines Therapeutics Inc., of San Diego, started a Phase I single- and multiple-dose study in 64 healthy elderly volunteers for NGX267, a treatment for Alzheimers disease. The study follows successful completion of the companys first Phase I study in which NGX267 was administered as single doses to healthy adult males and was shown to be well tolerated. In preclinical studies, NGX267 has shown its potential to reduce symptoms and slow disease progression.