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Other News To Note
(BioWorld Today), of Schaumburg, Ill., and American BioScience Inc., of Santa Monica, Calif., said positive results were observed with dose-dense combination therapy in early stage breast cancer patients who received Adriamycin plus Cytoxan followed by Abraxane as adjuvant treatment. Activity also was observed in a combination study of Abraxane and carboplatin in multiple solid-tumor types, including lung and breast cancer. The data were reported at the 28th Annual San Antonio Breast Cancer Symposium.
Barrier Therapeutics Inc., of Princeton, N.J., said the FDA accepted for filing the companys new drug application for Sebazole (ketoconazole) topical gel to treat seborrheic dermatitis. The product consists of 2 percent ketoconazole, an antifungal agent, formulated in a waterless gel for once-daily application. The NDA was submitted to the FDA in September.
BioInvent International AB, of Lund, Sweden, said the subscription period for its preferential rights issue ended Dec. 2 and interest in participation in the issue was substantial. The issue has raised SEK160 million (US$21 million) for BioInvent before costs. The number of shares in the company following the issue is 47.2 million. The share issue enables BioInvent to push forward its four product candidates in development.
Bionovo Inc., of Emeryville, Calif., said results from a Phase I trial of BZL101 in patients with refractory, metastatic breast cancer showed that the oral drug candidate has a favorable tolerability profile, and demonstrates evidence of clinical activity. Of the 16 evaluable patients, four had stable disease for more than 90 days, three had stable disease for more than 180 days, and five patients showed objective tumor regression, one of which was 1 mm short of a partial remission based on RECIST criteria. Data were presented at the 28th annual San Antonio Breast Cancer Symposium.
Cardiome Pharma Corp., of Vancouver, British Columbia, started a Phase IIa pilot study of oral RSD1235 for the prevention of recurrence of atrial fibrillation. The double-blind, placebo-controlled, randomized, dose-ranging study will measure the safety and efficacy of oral RSD1235 over 28 days of oral dosing. The study will enroll 180 patients across 75 centers in the U.S., Canada and Europe.
Cephalon Inc., of Frazer, Pa., entered an agreement with Jerusalem-based Teva Pharmaceutical Industries Ltd. and Teva Pharmaceuticals USA Inc. to settle its pending patent infringement disputes in the U.S. and the UK related to Provigil (modafinil) tablets. Cephalon will grant Teva a nonexclusive, royalty-bearing right to market and sell a generic version of Provigil. Tevas license in the U.S. will become effective in October 2011 absent a pediatric extension for Provigil, which would delay the entry date to April 2012. The license outside the U.S. enables a market entry in October 2012. An earlier entry by Teva may occur if another generic version of Provigil enters the market.
Chiron Corp., of Emeryville, Calif., closed its sale of $300 million in newly issued shares of its common stock at $43.50 per share to a subsidiary of Novartis AG, following receipt of regulatory approvals. Earlier this year, Novartis offered to buy out Chiron for $5.1 billion. (See BioWorld Today, Nov. 1, 2005.)
Cytori Therapeutics Inc., of San Diego, completed its formation of the recently announced regenerative medicine collaboration with Olympus Corp., of Tokyo. The joint venture, Olympus-Cytori Inc., will use Cytoris stem cell device for purifying adult stem cells in fat and develop its Celution System for cardiac disease. As part of the closing, Cytori received an $11 million initial payment. The deal could end up bringing Cytori a total of up to $55 million. (See BioWorld Today, Nov. 7, 2005.)
Dana-Farber Cancer Institute in Boston received a $16.5 million gift from Jack and Shelley Blais of Framingham, Mass., to establish a world-class protein research facility, the Blais Proteomics Center. The center will expand and accelerate the work of scientists focused on developing proteomic techniques for understanding the basic workings of normal and cancer cells.
Duska Therapeutics Inc., of Bala Cynwyd, Pa., is raising $2 million through a private offering to existing shareholders who are accredited investors. The shares will be offered at 25 cents each. Net proceeds will be used for general and administrative expenses, and potentially to fund the further development of the companys drug candidates, as well as a pending acquisition of a small molecule. The company, which is focused on ATP-related diagnostic and therapeutic technologies, also appointed Amir Pelleg, its founder, president and chief operating officer, to chairman.
Genomic Health Inc., of Redwood City, Calif., reported results showing that its Oncotype DX 21-gene panel breast cancer test changed treatment decisions in early stage breast cancer patients. The study evaluated the experience of four oncologists treating 68 early stage, estrogen-receptor-positive breast cancer patients, and found that knowledge of the Oncotype DX Recurrence Score altered the adjuvant treatment administered to 25 percent of the patients, compared to physicians original recommendations. Oncotype DX is designed to quantify the likelihood of recurrence and predict chemotherapy benefit.
GPC Biotech AG, of Martinsried, Germany, said a Phase II study evaluating its lead drug candidate, satraplatin, in combination with Taxol (paclitaxel) as a first-line therapy in patients with unresectable advanced non-small-cell lung cancer has opened for accrual. Satraplatin, partnered with Spectrum Pharmaceuticals Inc., of Irvine, Calif., is in a Phase III registrational trial as a second-line chemotherapy treatment for patients with hormone-refractory prostate cancer, and several additional studies are opening to explore the drug in other tumor types.
Immunomedics Inc., of Morris Plains, N.J., said results of a European trial of epratuzumab in combination with rituximab to treat patients with non-Hodgkins lymphoma demonstrated a 62 percent objective response rate, consisting of 25 percent complete responses and 37 percent partial responses. The median response duration was 16.5 months and the median time-to-progression was 11 months. The multicenter trial enrolled 32 patients who received four consecutive weekly infusions of 360 mg/m2 of epratuzumab followed by the same weekly schedule of 375 mg/m2 rituximab.
NeoPharm Inc., of Waukegan, Ill., received notification that its pivotal Phase III PRECISE trial of cintredekin besudotox in glioblastoma multiforme achieved the 270 intent-to-treat patient enrollment milestone. The company reported in November that the independent data monitoring committee reported that the study had reached the criterion for the second futility analysis of 100 deaths, and it is awaiting the committees analysis of the data, expected by the end of the month.
Pelias AG, of Vienna, Austria, began operations at the Campus Vienna Biocenter, where it will focus on the development of products to prevent and treat hospital-acquired infections, or nosocomial infections. The start-up is seed financed primarily through Intercell AG, also of Vienna, and a silent partnership of Kapital & Wert. Its lead product, a vaccine licensed from Emeryville, Calif.-based Chiron Corp. against Pseudomonas infection, has achieved a clinical proof-of-concept in a Phase IIa trial.
Sinovac Biotech Ltd., of Beijing, received RMB7 million (US$867,000) from Chinas Ministry of Science and Technology for the preclinical trials of its pandemic flu vaccine, Panflu, for humans. Since April, Sinovac has received more than $1 million from Chinese government departments for its vaccine, which includes an adjuvant (aluminum) to boost the immune response.
ViroPharma Inc., of Exton, Pa., said underwriters of its recent public offering of 9 million shares exercised in full their option to purchase about 1.4 million additional shares, for total net proceeds of about $163.8 million. Funds will be used for working capital and general corporate purposes, as well as going to pay a portion or all of the outstanding debt from the companys 6 percent subordinated convertible notes due March 2007. The offering is expected to close Dec. 12. (See BioWorld Today, Dec. 8, 2005.)
Xechem International Inc., of New Brunswick, N.J., acquired exclusive, worldwide licensing rights to a five-member heterocyclic anti-sickling compound from Virginia Commonwealth University in Richmond, Va. Early research has shown the agent to be an effective and relatively nontoxic treatment for sickle cell disease. Financial terms were not disclosed.
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