• Alkermes Inc., of Cambridge, Mass., and partner Johnson & Johnson, of New Brunswick, N.J., received a complete response letter to their supplemental new drug application seeking approval of Risperdal Consta (risperidone) for the adjunctive maintenance of bipolar disorder. The drug is approved for schizophrenia. The FDA asked for additional information but did not request additional studies.
• Alnylam Pharmaceuticals Inc., of Cambridge, Mass., said research from the firm's scientists published in the Feb. 10, 2009, Proceedings of the National Academy of Sciences demonstrated that RNAi silencing of the claudin-3 protein using lipidoid formulations of small interfering RNAs resulted in the suppression of ovarian tumor growth and metastases. Claudin-3 is a tight junction protein that is highly overexpressed in about 90 percent of ovarian tumors.
• AspenBio Pharma Inc., of Castle Rock, Colo., appointed Daryl Faulkner, executive chairman, to the additional position of interim CEO following the resignation of CEO and Director Richard Donnelly. The company also appointed Robert Caspari chief operating officer and chief medical officer.
• Astex Therapeutics Ltd., of Cambridge, UK, said it entered into a clinical trials agreement with Cancer Research UK to support the further clinical development of AT9283, Astex's multi-targeted kinase inhibitor of Aurora kinases A and B, JAK2 and Abl kinases, in children and adolescent patients with cancer. Under the terms of the agreement, a Phase I study of AT9283 in children and adolescent patients with relapsed or refractory solid tumors will be conducted through the Cancer Research UK's Drug Development Office in collaboration with the Children's Cancer and Leukemia Group. A further clinical study of AT9283 in children and adolescent patients with hematological malignancies also is planned. Astex retains all commercial rights to AT9283 and already has completed one Phase I trial with the compound in adult patients with solid tumors and another Phase I trial using an alternative dosing schedule in patients with solid tumors is ongoing. The firm said AT9283 also is showing early signs of clinical activity in a further Phase I/II trial in adult patients with hematological malignancies.
• Avexa Ltd., of Melbourne, Australia, said a Feb. 9 announcement from Cytopia Ltd., also of Melbourne, contained misleading statements about the funding requirements, specifically a $95 million shortfall, related to the merger between Avexa and Progen Pharmaceuticals Ltd., of Brisbane, Australia. Avexa said the statement from Cytopia, a Progen shareholder, is not consistent with any of the documents or commentary released by Avexa and Progen, and said any reference to a funding shortfall was inaccurate and misleading. Avexa said it has consistently stated in all releases to date that the merged entity will have $60 million in cash resources, which the company said should be sufficient to fund the estimated $45 million Phase III trial cost of its HIV drug ATC (apricitabine) up to the week 24 data milestone.
• Vical Inc., of San Diego, received a $2.3 million milestone payment from Asian partner AnGes MG Inc., of Osaka, Japan, related to progress in the ongoing Phase III melanoma trial of Allovectin-7. Vical has received $17.6 million to date of the $22.6 million AnGes committed under the companies' 2006 agreement. The trial is expected to complete enrollment by the end of the year. (See BioWorld Today, May 31, 2006.)