Adventrx Pharmaceuticals Inc., of San Diego, reported a 63 percent overall clinical benefit and a 38 percent objective response rate in measurable Phase II patients treated with CoFactor and 5-fluorouracil as a first-line treatment of metastatic colorectal cancer. Patients exhibited no grade 3 or 4 gastrointestinal or hematological toxicities. The company expects to announce final results in the fourth quarter.
Alexion Pharmaceuticals Inc., of Cheshire, Conn., said results of a new study show that treatment with an anti-C5 complement blocking antibody reduced the bronchial inflammation and airway constriction that prompts asthma's symptoms. The study was conducted in animal models by researchers at Alexion, the Yale University School of Medicine and the Brigham and Women's Hospital, and the results will be published in the June 2005 issue of Journal of Clinical Investigation.
Amersin Life Science Corp., of New York, said its subsidiary, Hubei Tongji Benda Ebei Pharmaceutical Co. applied to the State Food and Drug Administration for a license to produce Yan Hu Ning (potassium sodium dehydroandroan drographolide succinate) as a new pharmaceutical in injectable form. The company expects the license to be granted in the quarter ending July 31. Yan Hu Ning is prescribed as a fast-acting treatment for viral pneumonia and viral infections of the upper respiratory tract and is used in China to treat influenza. It also is used to treat chronic bronchitis, gastrointestinal tract infection and bacillary dysentery.
Astellas Pharma US Inc., of Deerfield, Ill., launched its systemic antifungal agent Mycamine (micafungin sodium) for injection to hospitals nationwide. The FDA approved it in March for the prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation and for the treatment of esophageal candidiasis.
Biopheresis Technologies Inc., of Cary, N.C., raised 6.5 million (US$8.2 million) in a Series A preferred stock financing with Scandinavian Life Science Venture, of Stockholm, Sweden, and First Ventury, of Heidelberg, Germany. The company completed a clinical trial last year that demonstrated capability of its technology to remove specific immune inhibitors from the blood of cancer patients. Proceeds will be used to conduct further trials.
Cellegy Pharmaceuticals Inc., of Brisbane, Calif., raised $6 million in a private placement of its common stock and warrants to existing stockholders and new institutional investors. The funds will support the company's cash needs through early 2006. The transaction consisted of the sale of 3.6 million shares at $1.65 each, and the issuance of 727,273 five-year Class A warrants at an exercise price of $2.25 per share, and 727,273 Class B warrants at $2.50 per share. Participating were SJ Investments LLC, Tisch Family Interests, Kingsway LLC, Greenway Capital, Kingsbridge Capital Ltd., and three directors. C.E. Unterberg, Towbin acted as the adviser and placement agent.
Depomed Inc., of Menlo Park, Calif., said additional data from 10 patients in its Phase II trial showed that Furosemide GR continued to produce comparable diuresis to immediate-release furosemide, but with variable urinary urgency and frequency between the treatment groups. The company is re-evaluating its decision to pursue the program, and plans to reallocate its resources to other late stage programs. Furosemide GR is a controlled-release formulation of the leading diuretic furosemide, which is used to treat edema in congestive heart failure patients.
FASgen Inc., of Baltimore, was awarded a $500,000 grant from the National Institutes of Health for completion of its final preclinical safety and animal efficacy work in support of the MDR-TB investigational new drug application submission for FAS20013. The company also secured a $2 million investment from a private investor to support the program. The company expects to submit the IND to start Phase I trials later this summer. MDR-TB is the disease caused by organisms resistant to common tuberculosis drugs.
GeneGo Inc., of St. Joseph, Mich., said that South San Francisco-based Exelixis Inc. licensed MetaCore, GeneGo's platform for mining high-throughput experimental data in the context of biological networks, pathways and human diseases. The companies said the technology will be used by Exelixis to develop differentiated compounds for the potential treatment of cancer and metabolic diseases. Financial terms were not disclosed.
Genmab A/S, of Copenhagen, Denmark, reported additional data from the HuMax-EGFr Phase I/II study in refractory head and neck cancer at the 2005 American Society of Clinical Oncology annual meeting. Assessed by FDG-PET, seven of 18 evaluable patients achieved partial metabolic response and four had stable metabolic disease one week after their fifth and last infusion. Assessed by CT scan, two of 19 evaluable patients achieved partial response, and nine patients had stable disease.
Genta Inc., of Berkeley Heights, N.J., said updated results from its Phase III trial of Genasense (oblimersen sodium) injection in patients with relapsed or refractory chronic lymphocytic leukemia built on preliminary results announced in December showing that the drug met its primary trial endpoint by demonstrating a statistically significant increase in the proportion of patients who achieved either a complete response or a nodular partial response. After a six-month follow-up, investigators found that one additional patient in the Genasense treatment group achieved a partial response, bringing the total to 20 patients (about 17 percent) in the Genasense plus chemotherapy group that achieved a complete or partial response, compared with eight patients (about 7 percent) in the placebo group. Genta also reported that extended follow-up has shown that the duration of complete/partial response is significantly superior for patients in the treatment group. Five of eight patients have relapsed on the chemotherapy-only arm, compared with four of 20 patients on the Genasense treatment arm. (See BioWorld Today, Dec. 7, 2004.)
Montigen Pharmaceuticals Inc., of Salt Lake City, closed a $5.2 million Series A financing. The money will provide Montigen with the resources to advance its lead compound into Phase I trials, and to strengthen its discovery and development engine. The company is in late-stage preclinical testing with MP-470, a small-molecule inhibitor of aurora-2 kinase.
Neose Technologies Inc., of Horsham, Pa., received a scheduled milestone payment from Novo Nordisk A/S, of Bagsvaerd, Denmark. The milestone was paid according to terms of a license agreement entered in November 2003 to use Neose's GlycoPEGylation technology to develop a next-generation version of a protein marketed by Novo Nordisk. Further details were not disclosed.
OSI Pharmaceuticals Inc., of Melville, N.Y., said its diabetes and obesity business unit, Oxford, UK-based (OSI) Prosidion, entered a worldwide nonexclusive license agreement under its dipeptidyl peptidase IV patent portfolio covering the use of DP-IV inhibitors for the treatment of Type II diabetes and related indications. The license, granted to a major pharmaceutical company, includes undisclosed up-front, milestone and royalty payments. OSI Prosidion said it expects to grant additional nonexclusive licenses in the future.
OxiGene Inc., of Waltham, Mass., said Combretastatin A4 Prodrug, its lead vascular-targeting agent, indicated both antitumor activity and no unexpected toxicity so far in the Phase Ib portion of a Phase Ib/II combination trial in patients with advanced cancer. The data were presented at the 2005 American Society of Clinical Oncology annual meeting in Orlando, Fla.
Pharmacyclics Inc., of Sunnyvale, Calif., said six patients with advanced refractory tumors achieved a partial response in a Phase I dose-escalation study of Xcytrin (motexafin gadolinium) injection used in combination with Taxotere (docetaxel). The ongoing study has enrolled 13 patients with metastatic cancer of the lung, ovary, prostate and breast. Interim data from a Phase II trial indicate Xcytrin is active in patients with advanced, recurrent renal-cell carcinoma. Data from both trials are being presented at the 2005 American Society of Clinical Oncology annual meeting in Orlando, Fla.
Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., initiated, along with partner Sanofi-Aventis Group, of Paris, a safety and tolerability study of the vascular endothelial growth factor (VEGF) Trap in combination with oxaliplatin/5-fluorouracil/leucovorin in patients with advanced solid malignancies. As part of a series of single-agent and combination trials of the VEGF Trap, the study will assess the pharmacokinetics of escalating doses delivered intravenously. Investigators also will measure objective response rate, duration of response and time to tumor progression.
Telik Inc., of Palo Alto, Calif., reported positive interim data from a multicenter Phase I/IIa trial evaluating Telcyta (TLK286) in combination with carboplatin and paclitaxel in the first-line treatment of advanced non-small-cell lung cancer at the American Society of Clinical Oncology's annual meeting. In the trial, researchers observed a 62 percent objective response rate and a 92 percent disease stabilization rate in the evaluable patients. The trial evaluated four doses of Telcyta at 400-, 500-, 750- and 1,000-mg/m2, along with standard doses of carboplatin and paclitaxel, administered every three weeks.
V.I. Technologies Inc., of Watertown, Mass., filed a shelf registration statement to offer and sell up to $50 million of equity securities. Proceeds would be used to fund the company's internal discovery and development programs, including the clinical development of its HIV candidate PA-457, and for other general corporate purposes.
Xenomics Inc., of New York, executed a contract with Eastern Virginia Medical School in Norfolk to begin human trials of the company's diagnostic DNA technology for the creation of safe and noninvasive prenatal tests for a range of genetic abnormalities, such as Down's syndrome. The agreement calls for a collaborative study investigating the ability of Xenomics' Transrenal-DNA to detect a number of fetal genetic problems through analysis of urine samples from pregnant women. Xenomics also recently announced a research agreement with North Shore-Long Island Jewish Health System to conduct clinical trials to detect Down syndrome in unborn children using maternal urine samples.