• Advanced Viral Research Corp., of Yonkers, N.Y., received approval from the FDA for its investigational new drug application for the systemic use of AVR118 in patients with advanced malignancies. The company is advancing the drug into a Phase II multicenter trial in U.S. patients with advanced cancer who are suffering from symptoms of progressive disease. AVR118 is a biopolymer that possesses immunomodulator activity.

• Affymetrix Inc., of Santa Clara, Calif., said the FDA granted regulatory clearance for the Affymetrix GeneChip System 3000Dx, an instrumentation system to analyze in vitro diagnostic (IVD) microarrays. The FDA clearance follows the August ISO certification of the instrument and array manufacturing facilities and the September IVD CE marking of the instrument system in the European Union.

• Genitope Corp., of Redwood City, Calif., completed its sale of 4.25 million unregistered shares of newly issued common stock at $14.25 apiece to selected institutional and accredited investors, resulting in estimated net proceeds to the company of about $57.2 million. WR Hambrecht + Co. LLC acted as the transaction's placement agent. Genitope plans to use proceeds to fund costs related to the leasing, build out and qualification of a commercial-scale manufacturing facility, to fund expenses related to manufacturing and potential commercialization of its cancer products, clinical trials and research, for the establishment of sales and marketing capabilities, as well as for general corporate purposes, such as working capital. (See BioWorld Today, Dec. 15, 2004.)

• Hemispherx Biopharma Inc., of Philadelphia, filed a lawsuit in Florida's federal court identifying a conspiratorial group seeking to manipulate its stock to bring about a hostile takeover of the company. The lawsuit also alleges that following a change of control, the group planned to take on additional Hemispherx shares by merging with privately held laboratory companies in which they are currently primary shareholders. Hemispherx's board rejected merger proposals from the defendants, who then allegedly began their plan to seize control of the company's cash and assets by driving down the stock price and publishing disparaging reports. The defendants include South African high net-worth individuals, a privately held South African biopharmaceutical company that was a former collaborator of Hemispherx, and certain Europeans.

• Inflazyme Pharmaceuticals Ltd., of Vancouver, British Columbia, said it would not proceed with the manufacture of cGMP Mirococept (APT070) as previously scheduled in the coming quarter. The company deferred its manufacturing plans to give it time to complete additional preclinical studies in support of the clinical program, allowing it to submit a more robust data package to present to the FDA prior to beginning Phase II. Inflazyme expects to complete its preclinical studies in the first half of next year.

• Large Scale Biology Corp., of Vacaville, Calif., received $1 million in federal funds to expand the company's participation in national biowarfare defense initiatives. The company will use the award to develop more effective candidates to prevent and treat biowarfare-related illnesses by using its GRAMMR (Genetic ReAssortment by MisMatch Resolution) DNA shuffling and molecular evolution technology. The new appropriation is in addition to the $1 million in funds from the Department of Defense to develop enhanced biowarfare therapies in collaboration with the U.S. Army Medical Research Institute of Infectious Diseases in Fort Detrick, Md.

• Northfield Laboratories Inc., of Evanston, Ill., filed a mixed shelf registration statement with the SEC to occasionally offer and sell up to $100 million of its securities. Terms of any such future offerings would be established at the time of the offering.

• PTC Therapeutics Inc., of South Plainfield, N.J., began a Phase I study of PTC124 to evaluate escalating dose levels in healthy volunteers. The product is orally administered and targets nonsense mutations. It is being investigated initially as a treatment for cystic fibrosis and Duchenne's muscular dystrophy. PTC124 recently completed testing in a single-dose, dose-escalation Phase I study in healthy volunteers. Preliminary results confirmed that the drug is orally bioavailable, well tolerated and safely achieves target plasma concentrations.

• SciClone Pharmaceuticals Inc., of San Mateo, Calif., said that its lead product Zadaxin was added to the Asian Pacific consensus recommendation for the treatment of patients with hepatitis B virus. The recommendation for approval is given by a team of Asia's leading hepatologists that was ratified at the recent meeting of the Asian Pacific Association for the Study of the Liver. SciClone believes the recommendation will help in the company's marketing efforts in the Pacific Rim countries where Zadaxin is approved, but not actively prescribed.

• Tercica Inc., of South San Francisco, filed a patent infringement complaint in a U.S. district court against Insmed Inc., of Glen Allen, Va., alleging that the latter's activities relating to the U.S. commercialization of Somatokine for growth hormone insensitivity syndrome infringe two issued U.S. patents exclusively licensed to the former. Tercica, which said Somatokine is a combination drug containing insulin-like growth factor-1 and insulin-like growth factor binding protein-3, licensed rights to develop, manufacture and commercialize rhIGF-1 from Genentech Inc., also of South San Francisco. In the suit, Tercica is seeking an injunction, damages and declaratory relief.

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