Abbott Laboratories, of Abbott Park, Ill., said the FDA approved its supplemental new drug application to reintroduce Abbokinase (urokinase) for the treatment of pulmonary embolism. Abbokinase is a thrombolytic therapy used to dissolve blood clots. Initially approved in 1978, Abbokinase has been used to treat an estimated 4 million patients.
Advanced Viral Research Corp., of Yonkers, N.Y., said its peptide nucleic acid immunomodulator, Product R, induced differentiation of the human promyelocytic leukemia cell line HL-60 in cell culture. The company said differentiated cells exhibit orderly growth patterns, subject to the normal controls of cellular growth. The research findings were presented Friday at a conference of the American Association for Cancer Research in Hilton Head Island, S.C.
AuRx Inc., of Baltimore, reported that a Mexican clinical team evaluating the AuRx therapeutic vaccine for genital herpes published initial results from a safety evaluation of the lowest dose in a Phase I/II trial, in the October issue of Cutis. There were no treatment-related adverse events and the side effects were similar to that of a sugar pill, the company said. The AuRx vaccine reduced the number of episodes threefold (p<.001 additionally recurrent hsv-2 episodes were completely prevented in percent of vaccinated patients as opposed to the given placebo all whom had during trial period. class="text"> Beyond Genomics Inc., of Waltham, Mass., was recognized in an announcement by Boston University School of Medicine for making a significant contribution to the $12 million contract recently awarded to the school by the National Heart, Lung and Blood Institute of the National Institutes of Health in Bethesda, Md. Beyond Genomics will provide access to its proteomics expertise and assist BUSM in developing a cardiovascular proteomics center.
CreAgri Inc., of Hayward, Calif., raised an additional $8.3 million in its first round of venture financing. The Series A was led by Burrill & Company, of San Francisco, and included POSCO BioVentures, DSM Venturing BV, Foragen Technologies Management LP and Aurora Equity LLC. CreAgri is a nutraceutical company focused on the discovery and development of antioxidant polyphenols from the pulp of olives.
Deltagen Inc., of Redwood City, Calif., discovered a drug target, designated DT044I, for the potential treatment of inflammatory disorders, including rheumatoid arthritis. The target flows from the company's high-throughput identification screens that have been built into its target discovery program. The company uses the screens to validate targets in its focus areas of immune disorders, metabolism and oncology. DT044I is associated with the cell membrane and is expressed by cells involved in both innate immunity, and cellular and humoral immune response.
Elite Pharmaceuticals Inc., of Northvale, N.J., said its wholly owned subsidiary, Elite Laboratories, signed an agreement with Ethypharm SA, of Paris, to develop a new prescription drug product. Elite will receive a one-time development fee for the first phase of feasibility study. Upon satisfactory results, the parties would enter a further development program. Ethypharm specializes in the development of various oral controlled-release formulations.
MacroChem Corp., of Lexington, Mass., said the FDA advised the company that further clinical trials of MacroChem's drugs containing its absorption enhancer SEPA were placed on clinical hold until issues regarding a transgenic mouse carcinogenicity study were resolved. During the hold, the company will be unable to conduct human trials on its SEPA-based investigational drug products. According to the FDA, the executive committee of its Carcinogenicity Advisory Committee determined SEPA is responsible for carcinogenic findings in a six-month transgenic TG.AC mouse assay. MacroChem's stock (NASDAQ:MCHM) dropped 26 cents Friday, or 37.1 percent, to close at 44 cents.
Epoch Biosciences Inc., of Bothell, Wash., said the National Cancer Institute in Bethesda, Md., will present results from a pilot study designed to evaluate the utility of Epoch's MGB Eclipse Probe System in real-time polymerase chain reaction assays. The study investigated numerous single nucleotide polymorphisms using a variety of technology platforms to assess the performance of each in a high-throughput environment. The study results will be used in the NCI's selection of the preferred platform for a larger study involving the analysis of 800 SNPs in a population of about 20,000 patient samples. The NCI will present at two conferences in October - the 5th International Meeting on Single Nucleotide Polymorphisms and Complex Genome Analysis in Reykjavik, Iceland, which began Friday and continues through today, and the 52nd annual meeting of the American Society of Human Genetics in Baltimore, which begins Tuesday and continues through Saturday.
Immtech International Inc., of Vernon Hills, Ill., said that Nasdaq is removing the fifth character "C" that was appended to the company's trading symbol on Sept. 16. Effective Monday, the company will resume trading under the symbol "IMMT." The Nasdaq Listing Panel determined to remove the fifth character because Immtech had evidenced compliance with current terms of the exception under which it was permitted to remain listed on the Nasdaq SmallCap Market.
Matritech Inc., of Newton, Mass., reached an agreement in principle for its NMP66 breast cancer test with Mitsubishi Kagaku Medical Inc., of Tokyo, a division of Mitsubishi Chemical. The companies signed the terms of the agreement and are developing final documents, Matritech said. Matritech's NMP66 protein is a biomarker present in the blood of breast cancer patients. Matritech will complete the development of the blood test method using Mitsubishi's input and conduct an initial validation study using specimens from women in Japan provided by Mitsubishi.
QLT Inc., of Vancouver, British Columbia, and Novartis Ophthalmics, of Bulach, Switzerland, started patient enrollment in two Phase III trials using photodynamic therapy with verteporfin for the treatment of multiple basal cell carcinoma. The trials are designed to determine the safety and efficacy of verteporfin with PDT to eliminate multiple basal cell carcinoma. About 180 patients will be enrolled in two randomized, multicentered, placebo-controlled trials at 19 centers in North America.
SciQuest Inc., of Research Triangle Park, said the Nasdaq Stock Market approved its request to transfer SciQuest's stock to the Nasdaq SmallCap Market effective at the opening of trading Oct. 11. The company's stock will continue trading under the symbol "SQST." SciQuest said the move will allow it to take advantage of the extended grace period provided by the Nasdaq Small Cap Market to meet Nasdaq's minimum $1 per share closing bid price requirement for continued listing.
Sucampo Pharmaceuticals Inc., of Bethesda, Md., said that Mizuho Capital Co. Ltd. and Diamond Capital Co. Ltd. purchased $3 million and $1.5 million, respectively, of its Series A convertible preferred stock. The Mizuho and Diamond deals are the second set of equity investments for the company in 45 days. In August, Sucampo said that three companies had purchased or agreed to purchase $16 million of its Series A convertible preferred stock. Sucampo said it intends to use the net proceeds from the sale for development activities related to drug compounds in its clinical development pipeline focusing on gastrointestinal, ophthalmic and liver diseases.
Trimeris Inc., of Durham, N.C., and Hoffmann-La Roche Inc., of Nutley, N.J., said the FDA notified the companies that the new drug application for Fuzeon (enfurvitide, formerly known as T-20) is fileable and has been granted priority review status. Designed for the treatment of HIV-1 in combination with other antiretroviral agents, Fuzeon is the most clinically advanced in an investigational class of anti-HIV drugs called fusion inhibitors. The NDA was submitted by Roche and Trimeris on Sept. 16 and will be reviewed within six months. (See BioWorld Today, Sept. 18, 2002.)
University of Auckland scientists in New Zealand along with those at the Weill Cornell Medical College in New York reported on the effectiveness of a new gene therapy approach to Parkinson's disease and the potential for the therapy to affect the overall progression of the disease. The findings were reported in a study published Oct. 10 in the journal Science. Based on the study and other data, the FDA gave its approval to begin testing the therapy in a Phase I trial. The university said it will be the first time that gene therapy will be used in patients with Parkinson's disease.
ViroLogic Inc., of South San Francisco, reported study results published in the current issue of the Journal of Acquired Immune Deficiency Syndromes that demonstrate the potential clinical benefit of using phenotypic and genotypic HIV-1 drug resistance assays together. According to the company, PhenoSense GT technology provides complementary information about viral drug susceptibility, resulting in a more complete resistance profile and facilitating the optimum treatment of patients with HIV. Over the course of the study, researchers discovered conflicting phenotypic and genotypic results for one or more drugs in 83 percent of about 1,400 patient plasma samples.