• AEterna Zentaris Inc., of Quebec City, said the European Medicines Agency indicated an ongoing Phase III trial of PI3K/Akt pathway inhibitor perifosine plus Velcade (bortezomib, Millennium/Takeda Pharmaceutical Co. Ltd.) in multiple myeloma will be sufficient to support European marketing authorization. AEterna is seeking similar feedback regarding its ongoing Phase III colorectal cancer trial. Both trials are being conducted by partner Keryx Biopharmaceuticals Inc., of New York. Shares of AEterna (NASDAQ:AEZS) popped 27 cents, or 19.6 percent, to close at $1.65 on Thursday.

• Ambrilia Biopharma Inc., of Montreal, received court approval of its previously announced proposal to dispose of a limited partnership interest with subsidiary Cellpep Pharma Inc. The action would generate about $4 million for Ambrilia and Cellpep.

• Cannasat Therapeutics Inc., of Toronto, received shareholder approval to change its name to Cynapsus Therapeutics Inc. The company's stock symbol will remain as "CTH" on the TSX Venture Exchange.

• Cell Therapeutics Inc., of Seattle, is cutting 36 employees and reducing expenses by 21 percent in a move that is expected to save $16 million in 2010. The company's monthly net operating burn is expected to be $4.4 million starting this quarter. Earlier this month, CTI received an FDA complete response letter for non-Hodgkin's lymphoma drug Pixuvri (pixantrone) requesting an additional trial. (See BioWorld Today, April 12, 2010.)

• Circadian Technologies Ltd., of Melbourne, Australia, said its lead anticancer therapeutic, VGX-100, a fully human monoclonal antibody targeting the VEGF-C growth factor, inhibited tumor growth in a variety of different animal models, or tumor xenografts, of human cancer.

• CombinatoRx Inc., of Cambridge, Mass., published preclinical data in the journal Blood regarding a multi-target mechanism that combines adenosine A2A receptor agonists with PDE inhibitors as an adjuvant to glucocorticoids for B-cell malignancies including multiple myeloma. The combination caused rapid inhibition of proliferation and induction of apoptosis. The approach was identified using CombinatoRx's high throughput screening technologies.

• D-Pharm Ltd., of Rehovot, Israel, reached an agreement with the FDA on a special protocol assessment for its Phase III trial of lead drug DP-b99 in moderate to severe ischemic stroke. The randomized, double-blind, placebo-controlled, 770-patient study will compare DP-b99 vs. placebo administered within a nine-hour therapeutic window on stroke outcome using mRS "Shift Analysis" at day 90. DP-b99 is designed to inhibit metal-dependent enzymes that are overexpressed in stroke. (See BioWorld Today, Nov. 10, 2009.)

• ImmunoGen Inc., of Waltham, Mass., said its partner Roche AG, of Basel, Switzerland, and its subsidiary, Genentech Inc., of South San Francisco, plan to submit a U.S. marketing application in 2010 for use of trastuzumab-DM1 (T-DM1) for advanced HER2-positive metastatic breast cancer. T-DM1 comprises ImmunoGen's DM1 cancer-cell killing agent linked to the HER2-targeting antibody, trastuzumab, developed by Genentech. T-DM1 is in global development by the Roche under a collaboration agreement between Genentech and ImmunoGen.

• Life Technologies Corp., of Carlsbad, Calif., said it has teamed with researchers from Stanford University School of Medicine and other institutions to discover a genomic component that plays a key role in promoting breast cancer progression. The firm noted that a study published this week in the journal Nature detailed how levels of a specific kind of noncoding RNA molecule in primary breast tumors regulate metastasis and tumor invasiveness and may be an important target for cancer diagnosis and therapy. A key to that finding was the ability of TaqMan noncoding RNA assays, from Applied Biosystems, part of Life Technologies, to accurately measure expression levels of that molecular marker in different breast cancer samples. The TaqMan noncoding RNA assays helped uncover regulatory roles of noncoding RNAs in breast cancer.

• Peregrine Pharmaceuticals Inc., of Tustin, Calif., said preclinical data, published in the journal Breast Cancer Research and Treatment, showed that bavituximab combined with an investigational apoptosis-inducing drug produced powerful antitumor effects, completely eradicating 30 percent of tumors in a model of advanced breast cancer. The firm noted that bavituximab in combination with chemotherapy is in ongoing Phase II trials for the treatment of advanced breast cancer and non-small-cell lung cancer.

• Regulus Therapeutics Inc., of Carlsbad, Calif., presented new data from its metabolic disease program at the "Diabetes" Keystone Symposium in Whistler, British Columbia. The new preclinical research findings showed that therapeutic oligonucleotides targeting microRNA are able to improve insulin resistance and normalize plasma glucose in mouse models of diabetes while having no significant effect on glucose or insulin levels in normal mice.

• Repros Therapeutics Inc., of The Woodlands, Texas, said it believes it has regained compliance with the minimum stockholders' equity requirement for continued listing on the Nasdaq.

• Santarus Inc., of San Diego, said the U.S. District Court for the District of Delaware has ruled that five patents covering the firm's Zegerid (omeprazole-sodium bicarbonate) are invalid due to obviousness. The patents were the subject of lawsuits brought by Santarus against Par Pharmaceutical Inc., of Woodcliff Lake, N.J., which had submitted an abbreviated new drug application to the FDA in 2007 seeking marketing approval for generic versions of Zegerid. The case was heard in a five-day bench trial that concluded July 17, 2009. Santarus said it plans to appeal the court's ruling to the U.S. Court of Appeals for the Federal Circuit Court. Shares of Santarus (Nasdaq:SNTS) fell $1.77, or 33 percent Thursday, closing at $3.59. Shares of Par (NYSE:PRX) rose $2, closing at $28.12.

• Swedish Orphan Biovitrum, of Stockholm, Sweden, signed an exclusive 10-year agreement to distribute Rhucin (conestat alfa), a recombinant human C1 inhibitor for the acute treatment of hereditary angioedema attacks, from Pharming Group NV, of Leiden, the Netherlands, in 24 EU countries, Norway, Iceland and Switzerland. Under the deal, Swedish Orphan will pay Pharming an undisclosed up-front payment, a regulatory approval milestone and a supply price, which includes tiered performance-based royalties. Swedish Orphan also has the right to participate in the future development and distribution of Rhucin in the agreed countries for additional indications. Pharming submitted an application for Rhucin to the European Medicines Agency in September 2009.

• VaxGen Inc., of South San Francisco, is looking to merge with diagnostics firm DiaDexus Inc., also of South San Francisco. VaxGen would issue 51.6 million shares, worth roughly $21.7 million: more than its $13 million market cap but less than its $28 million in net cash. VaxGen shareholders would own 39.1 percent of the merged company, if they agree to the merger, but that's no guarantee - they've previously rejected mergers with Oxigene Inc. and Raven Biotechnologies Inc. (See BioWorld Today, March 31, 2008, and Feb. 5, 2010.)

• XOMA Ltd., of Berkley, Calif., said it received a $1 million milestone payment from Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, for achieving a pre-established preclinical milestone under the companies' 2006 antibody collaboration agreement, which also calls for additional future milestone payments and royalties on product sales. In the collaboration, XOMA is using its extensive collection of antibody discovery, development and optimization technologies to discover therapeutic antibodies against multiple targets selected by Takeda.