¿ Aronex Pharmaceuticals Inc., of The Woodlands, Texas, started a Phase II trial with Annamycin in refractory breast cancer patients who overexpress P-glycoprotein in the tumor cell. Annamycin is a novel liposomal anthracycline designed to treat a board range of cancers, including those that exhibit multidrug resistance.
¿ Athersys Inc., of Cleveland, formed a collaboration with Gene-Cell Inc. to deliver Athersys' synthetic microchromosome (SMC) vectors into human stem cells using Gene-Cell's automated microinjection technology. The collaboration will focus on developing and optimizing proprietary systems for the delivery of SMCs into human stem cells and other more differentiated cell types.
¿ Avant Immunotherapeutics Inc., of Needham, Mass., said its Phase I/II study of TP10 met its objectives in infants undergoing cardiac surgery. TP10, a complement inhibitor, has the potential to reduce the consequences of reperfusion injury and to improve post-operative outcomes in infants undergoing cardiac surgery. The company is planning pivotal Phase III trials.
¿ Avax Technologies Inc., of Kansas City, Mo., started a multicenter Phase II study of M-Vax, its autologous cancer vaccine, in patients with Stage IV melanoma who have measurable disease, but limited primarily to lung metastases. Patients will receive seven weekly M-Vax vaccinations followed by a six-month booster. The study will evaluate M-VAX's ability to cause tumor regression in patients with more advanced disease. Avax also is conducting a pivotal registration trial of M-Vax in Stage III melanoma.
¿ Aventis Behring LLC, of King of Prussia, Pa., said its Gammar-P I.V. Immune Globulin intravenous, is now indicated for the treatment of primary immune deficiency in adolescents and children who are at an increased risk of infection. Gammar-P I.V. is the only pasteurized immune globulin available intravenously in the U.S., the company said. Aventis Behring was formerly Centeon LLC.
¿ Axonyx Inc., of Boston, said that Phase I trials of Phenserine, its lead drug for Alzheimer's disease, showed a significant inhibition of acetylcholinesterase, a mechanism known to improve memory and cognition in Alzheimer's patients. Phenserine is a highly selective, reversible acetylcholinesterase inhibitor. Phase II trials are planned for the end of the year.
¿ Contech, of Palo Alto, Calif., and DigiScents Inc., of Oakland, Calif., said they have isolated, cloned and sequenced 126 human olfactory receptor genes. This discovery, along with the publicly available research, gives DigiScents access to close to half of the estimated 1,000 genes that code for human olfactory receptors. Olfactory receptors are expressed in neurons of the olfactory epithelium and allow people to detect and distinguish smells.
¿ DepoMed Inc., of Foster City, Calif., said it has moved its headquarters to Menlo Park, Calif.
¿ Discovery Laboratories Inc., of Doylestown, Pa., said its preliminary evaluation of its Phase IIa trial of SuperVent aerosol solution in cystic fibrosis patients confirmed that patients taking SuperVent had a significant decrease in sputum interleukin-8 levels compared to those taking a placebo. SuperVent has anti-inflammatory activity through inhibition of neurofibromatosis (kappa) B, and reduces the density of sputum.
¿ Enzo Biochem Inc., of Farmingdale, N.Y., reported successful preliminary results of a human trial involving EHT899 to treat patients with chronic hepatitis B infections. In the majority of the 15 patients treated, a substantial improvement of disease symptoms was noted, including a significant decrease in the degree of inflammation in the patient's liver. No side effects were observed. The company is preparing to start Phase II trials.
¿ Neose Technologies Inc., of Horsham, Pa., said that the underwriters of its recent initial public offering have acquired an additional 300,000 shares of common stock, bringing another $9 million to the company. The total proceeds from the IPO are $69 million. There are now 13.9 million shares outstanding. (See BioWorld Today, Feb. 14, 2000, p. 1.)
¿ ImmuCell Corp., of Portland, Maine, reported positive preliminary results from its trial of DiffGAM bovine anti-Clostridium difficile immunoglobulins in the treatment of Clostrridium difficile-associated with diarrhea (CDAD). In this Phase I/II trial, the prospective statistical endpoint was met, resulting in the early termination of the Primary CDAD arm with patients with their first diagnosed CDAD episode. Ten of the 12 evaluable patients met the clinical endpoint, which was diarrhea reduction during the treatment phase.
¿ Incara Pharmaceuticals Corp., of Research Triangle Park, N.C., said it would use a previously untapped pool of livers for its liver precursor cell transplant program. The livers will come from non-beating-heart donors. Currently, liver transplantation procedures require a donor who has undergone brain death but whose heart is still beating, which happens in 1 percent to 2 percent of all hospital deaths. Researchers have found that viable liver precursor cells can be isolated from human livers donated by non-beating-heart donors. Incara intends to start human trials in 2001 investigating the transplantation of liver precursor cells by intravenous infusion as a treatment for patients suffering from liver failure or certain inherited metabolic diseases.
¿ Neurocrine Biosciences Inc., of San Diego, expanded its excitatory amino acid transporters (EAATs) research program into retinal cell death associated with ischemic damage. In addition, it was awarded a National Institutes of Health grant to fund identification of novel compounds for the alleviation of neuronal cell death in the retina in response to a wide range of conditions, including diabetic, retinopathy and glaucoma.
¿ Oncolytics Biotech Inc., of Calgary, Alberta, said that Reolysin, its human reovirus, showed no side effects in dogs, and that five out of the six treated dogs had tumor regression or tumor clearing. In addition, the two animals with systemic disease experienced remote tumor regression. The study's objective was to see if Reolysis was safe to administer to large mammals at a dose equivalent to one of the doses used in the upcoming human trial.
¿ Ophidian Pharmaceuticals Inc., of Madison, Wis., sold five of its patent applications for $1.3 million. The patents are unrelated to Ophidian's core development programs. The company has 90 patents issued or pending.
¿ Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., started a Phase II dose-ranging trial for Axokine second-generation ciliary neurotrophic factor in obese patients. Axokine is being developed for the treatment of obesity and complications of obesity such as Type II diabetes. The double-blind, placebo-controlled multicenter trial will include 175 severely obese patients who will be treated for 90 days.
¿ Sepragen Corp., of Hayward, Calif., said that the redeemable Class A and Class B warrants, issued as part of the company's March 23, 1995, initial public offering, expired as of March 24.
¿ TranXenoGen Inc., of Shrewsbury, Mass., completed a $1.5 million offering of Series C and Series D preferred stock to a group of existing private investors and to institutional investors, including WestLB Panmure Ltd., of London.
¿ UroGen Corp., of San Diego, received a grant from the National Cancer Institute to support development of its prostate cancer gene therapy product. The award, totaling more than $500,000 for two years, will help further develop UroGen's adenoviral vector gene therapy technology.
¿ Vion Pharmaceuticals Inc., of New Haven, Conn., will start a Phase I trial of Tumor Amplified Protein Expression Therapy (TAPET) bacterial vector at the National Cancer Institute in Bethesda, Md. The trial will determine the safety and tolerability of intravenously injected TAPET in patients with advanced cancer that has progressed despite the best available therapy. The company also said it will redeem its Class B warrants on April 27, which entitle the holder to purchase one share of common stock for $6.23. There are about 2.15 million Class B warrants outstanding. The company will use the money for working capital, including research and development.