Avanir Pharmaceuticals Inc., of San Diego, said that effective Sept. 6, Eric Brandt will become president and CEO and a member of its board. Brandt was previously chief financial officer and executive vice president of finance and technical operations at Allergan Inc., of Irvine, Calif. Avanir is focused on developing and commercializing therapeutics for chronic diseases.
Benitec Ltd., of Mountain View, Calif., said the Australian Patent Office has upheld all of the company's issued patents from two ordered reviews resulting from a patent-infringement suit filed in March 2004 and a successful resolution of a contract dispute with Promega. Benitec focuses on therapeutics for hepatitis C virus and human immunodeficiency virus and is listed on the Australian Stock Exchange.
Ciphergen Biosystems Inc., of Fremont, Calif., signed an agreement with the University of Kentucky for exclusive rights to license discoveries made during a research collaboration in ovarian cancer. Terms of the agreement call for Ciphergen to provide its suite of proteomic solutions designed for biomarker discovery and development of assays to analyze samples collected at the university. Researchers will focus on finding specific proteins to differentiate malignant from benign ovarian conditions.
Inhibitex Inc., of Atlanta, completed its previously announced private placement of 5 million shares of common stock at $8.25 per share, for gross proceeds of $41.25 million. The company expects to use these funds to continue development of Veronate, which entered Phase III trials last year to prevent hospital-associated infections in premature infants. Proceeds also will be used to advance its Aurexis program for the treatment of Staphylococcus aureus bloodstream infections, and for other research programs and general corporate purposes. (See BioWorld Today, Aug. 19, 2005.)
Ligand Pharmaceuticals Inc., of San Diego, received a Nasdaq staff determination letter regarding the company's failure to timely file its Form 10-Q for the period ended June 30. A Nasdaq panel previously agreed to continue the listing on the Nasdaq National Market if the company files its Form 10-K for the fiscal year ended Dec. 31, 2004, on or before Aug. 31, and files its first quarter and second quarter Forms 10-Q by Sept. 9. Until the company is current with its periodic reporting requirements with the SEC, its trading symbol will remain LGNDE.
MediGene AG, of Martinsried, Germany, initiated a Phase II trial of EndoTAG-1 for the treatment of advanced pancreatic cancer. EndoTAG-1 is a combination of paclitaxel and a carrier system that targets paclitaxel to newly formed blood vessels. EndoTAG starves cancerous tumors by destroying blood vessels and thereby cutting off nutrient supply.
Meditech Research Ltd., of Melbourne, Australia, was offered a commercial ready grant from the Australian government. The grant will contribute $2.98 million over three years toward the development and commercialization of HyCAMP, Meditech's lead anticancer product which is in Phase II testing.
Mesoblast Ltd., of Melbourne, Australia, entered an agreement with what it called "one of the world's largest medical device companies." The unnamed medical device company, which has a "major international presence in the orthopedic field," will provide FDA-approved carrier materials for use in combination with Mesoblast's adult stem cells in preclinical trials. No further details were disclosed.
NeoPharm Inc., of Lake Forest, Ill., said the FDA approved an amendment to the company's special protocol assessment to include an interim efficacy analysis of data from its pivotal Phase III PRECISE trial of cintredekin besudotox for the treatment of glioblastoma multiforme. The interim analysis, expected after notification of 160 deaths, is projected to occur during the second quarter of 2006. The SPA already included two futility analyses and a final efficacy analysis.
Neuren Pharmaceuticals Ltd., of North Sydney, Australia, received positive results for its neuroprotective compound, NNZ-2566, showing it reduced functional deficits from severe brain trauma. Those findings were presented by U.S. Army scientists last week at the Advanced Technology Applications for Combat Casualty Care conference in St. Petersburg, Fla. The Walter Reed Army Institute of Research is collaborating with Neuren to optimize the treatment dose and duration and to evaluate its effects on a new biological marker of brain injury in preparation for clinical trials. Neuren expects to start Phase I trials in early 2006.
Power3 Medical Products Inc., of The Woodlands, Texas, said it discovered a group of breast cancer protein biomarkers in preliminary studies of blood serum. Scientists at Power3 believe they will be able to use these biomarkers to discriminate among three groups of women: those with breast cancer, those with benign breast disease and those with no detectable breast cancer. An initial study correctly identified all 18 normal women, 32 of 33 women with breast cancer, and 23 of 25 with benign breast disease.
pSivida Ltd., of Perth, Australia, raised $4.2 million through a private placement of 650,000 American depository receipts at $6.50 each. Each depository receipt represents 10 ordinary shares, and the offering was structured as a private investment in public equity. pSivida focuses on the development of BioSilicon, a modified form of silicon, and potential applications of BioSilicon are being developed through pSivida's subsidiary AION Diagnostics Ltd.
Regenera Ltd., of Perth, Australia, received its first licensing payment of $1.3 million from Alcon Manufacturing Ltd. on a steroid product used during ocular surgery. Regenera develops ophthalmology drugs, specifically targeting diseases of the back of the eye and those related to diabetes.
Rosetta Biosoftware, of Seattle, said the FDA's Center for Drug Evaluation and Research will evaluate its Resolver system for gene expression data management and analysis. CDER will use the system in its Voluntary Genomics Data Submissions program to analyze microarray data from sponsors.
Stem Cell Therapeutics Corp., of Calgary, Alberta, signed a letter of intent for Medicon A/S, of Birkerod, Denmark, to conduct its first Phase I trial in the NTx-265 therapeutic program for the treatment of stroke. SCT previously engaged Medicon to prepare a synopsis for the trial, which was accepted by the Danish regulatory authority and regional ethics committee.