• Actelion Ltd., of Allschwil, Switzerland, said Health Canada approved a label expansion of Tracleer (bosentan) for patients with mildly symptomatic World Health Organization Functional Class II pulmonary arterial hypertension. The FDA last month approved the same label expansion for the endothelin receptor antagonist, which previously was approved for Class III and IV patients.

• Advanced Cell Technology Inc., of Worcester, Mass., said it will be completing the preclinical work necessary for filing an investigational new drug application for its retinal pigment epithelium cell program for eye diseases. To date, no adverse events have occurred in testing. Advanced Cell expects to submit the IND before the end of this year.

• BioAlliance Pharma SA, of Paris, said a U.S. District Court judge granted the motion to dismiss a civil action against the company and one of its executives filed by Eurofins Pharma US Holdings Inc., of Des Moines, Iowa, regarding the diagnostic technology Phenoscript, a test for HIV drug resistance. Eurofins filed an appeal.

• Bionovo Inc., of Emeryville, Calif., was notified by Nasdaq that it was not in compliance with the $1 minimum share price rule. The company has until March 15, 2010, to regain compliance

• Bio-Path Holdings Inc., of Houston, executed an exclusive license with the University of Texas M.D. Anderson Cancer Center to develop liposome tumor targeting technology. The technology, which is in the field of neutral lipid-based liposome delivery of antisense technologies and FAK siRNA, is aimed at enhancing the company's liposome delivery technology by adding vectors to the liposomes targeted to a receptor that is specifically overexpressed on a majority of solid and hematological tumors. Financial terms of the agreement were not disclosed. Bio-Path expects to start the first Phase I trial using that delivery technology in the fourth quarter.

• Cell Therapeutics Inc., of Seattle, withdrew its European marketing application for Opaxio (poliglumex paclitaxel) in non-small-cell lung cancer after the advisory committee expressed reservations. Previous Phase III trials of Opaxio in NSCLC failed to meet their endpoints, and CTI is now focusing on ovarian cancer, where a Phase III trial is ongoing. CTI also said it will meet with the FDA to design a pivotal trial in esophageal cancer. (See BioWorld Today, May 3, 2005.)

• Cellceutix Corp., of Beverly, Mass., has successfully completed animal model tests on a taxane-resistant, estrogen receptor-negative breast cancer human cell line, MDA-MB-435s, using its pharmaceutical compound Kevetrin. Tumor volume was reduced by 72 percent and tumor growth was delayed by more than 52 percent with Kevetrin when compared with paclitaxel (Taxol) (p < 0.01) or with cisplatin (p < 0.01).

• Cleveland BioLabs Inc., of Buffalo, N.Y., received a $458,512 grant from the NIH's National Institute of Allergy and Infectious Diseases to continue preclinical studies of Protectan CBLB502 in thrombocytopenia associated with radiation exposure. CBLB502 is a derivative of a microbial protein and also is in Phase I development for acute radiation syndrome.

• GeneThera Inc., of Wheat Ridge, Colo., licensed from Universita di Roma Tor Vergata and Universita Cattolica del Sacro Cuore development rights to a drug that may be applicable in treating the veterinary mycobacterial disorder Johne's disease as well as Crohn's disease and irritable bowel syndrome in humans.

• MAP Pharmaceuticals Inc., of Mountain View, Calif., said data from an in vitro study of Levadex (MAP0004) orally inhaled migraine therapy showed it may produce fewer adverse events than those seen with intravenous dihydroergotamine. Those results will be published in a paper in an upcoming issue of the journal Headache and currently are available in the online version of the journal.

• Marshall Edwards Inc., of New Canaan, Conn., was notified by Nasdaq that it was not in compliance with the $1 minimum share price rule. The company has until March 15, 2010, to regain compliance.

• Protalix Biotherapeutics Inc., of Carmiel, Israel, reported preclinical data on pr-antiTNF, a biosimilar version of etanercept (Enbrel, Amgen Inc.). Produced using the company's ProCellEx technology, pr-antiTNF is a plant cell-expressed recombinant fusion protein. Pr-antiTNF has an identical amino acid sequence to Enbrel. In vitro and preclinical animal studies have demonstrated that pr-antiTNF exhibits similar activity to Enbrel.

• Seattle Genetics Inc., of Bothell, Wash., has developed a sugar-engineered antibody technology to increase the potency of monoclonal antibodies through enhanced effector function. The technology comprises modified sugars that inhibit the incorporation of fucose into the carbohydrate chains of monoclonal antibodies, resulting in enhanced antibody-dependent cellular cytotoxicity activity in preclinical models. The modified sugars can be added to standard cell culture media, without impacting manufacturing processes and while maintaining yields and reproducible product quality, the company said. The technology was presented at the Americas Antibody Congress in Washington.

• Variation Biotechnologies Inc., of Cambridge, Mass., appointed Jeff Baxter as CEO, replacing Francisco Diaz-Mitoma, a founder of the company who will remain a board member and transition to chief scientific officer and president of Canadian operations. Prior to joining Variation, Baxter was a managing partner of venture capital firm the Column Group and played a pivotal role in the creation of Immune Design Corp., a vaccine company.

• XOMA Ltd., of Berkeley, Calif., was notified by Nasdaq that it was not in compliance with the $1 minimum share price rule. The company has until March 15, 2010, to regain compliance.