• Advaxis Inc., of North Brunswick, N.J., said it provided a complete response to the FDA's questions regarding the use of Lovaxin C, a live Listeria vaccine directed against human papillomavirus-induced disease, in the treatment of cervical intraepithelial neoplasia. Lovaxin C is a bioengineered microbe designed to infect the immune system and deliver a protein composed of an HPV antigen fused to a fragment of the Listeria protein LLO to stimulate multiple simultaneous immune mechanisms. Pending FDA approval, Lovaxin C is set to start a Phase II trial.

• Basilea Pharmaceutica Ltd., of Basel, Switzerland, said Toctino (alitretinoin), a once-daily oral treatment for adults with severe chronic hand eczema who are unresponsive to topical corticosteroids, was approved by Finland's National Agency for Medicines. Marketing applications also are under regulatory review in Canada and Switzerland.

• Boulder BioTechnology Inc., of Boulder, Colo., said it was awarded a $1.6 million Phase II Continuing Renewal Small Business Innovation Research grant from the National Institute of Neurological Disorders and Stroke to support work on its long-acting beta interferon program. Money will be used to perform preclinical studies needed for filing an investigational new drug application. Receipt of the entire grant is contingent upon the achievement of certain research milestones.

• EPIX Pharmaceuticals Inc., of Lexington, Mass., said it received notice from Nasdaq that it was not in compliance with listing rules, which require a minimum $50 million market cap. EPIX has until Nov. 10 to regain compliance.

• Geron Corp., of Menlo Park, Calif., said preclinical data demonstrated that its telomerase inhibitor drug, GRN163L, significantly boosted the effects of Herceptin (trastuzumab, Genentech Inc.) against HER2-positive breast cancer cells and restores sensitivity to trastuzumab in trastuzumab-resistant tumor cells. Results of the study showed that GRN163L acted synergistically with trastuzumab to inhibit growth of each tumor cell at all combination doses tested. A mismatch control lipidated oligonucleotide did not enhance or alter the growth inhibition effects of trastuzumab. Those data were published online in Breast Cancer Research and Treatment.

• Laboratories Almirall SA, of Barcelona, Spain, said it plans to advance the development of aclidinium bromide, an inhaled anticholinergic, in moderate to severe chronic obstructive pulmonary disease with partner, New York-based Forest Laboratories Inc. The company will work with European regulators to evaluate options for filing for the drug's approval as a monotherapy and plan to meet with the FDA in early 2009 to review data from the two Phase III trials, which showed that aclidinium bromide improved lung function and was well tolerated, meeting the studies' primary endpoints, though results were less robust than expected. U.S. filing currently is anticipated for 2011.

• Lipoxen plc, of London, said it entered a research agreement with Cambridge Biostability Ltd., of Cambridge, UK, as well as the University of Cambridge, UK, and The Health Protection Agency, to develop a vaccine technology aimed at achieving greater efficacy and eliminating the need for cold-chain distribution. Under the terms, the parties will be working to create vaccine materials that are more stable, have a long shelf life, require fewer doses in order to be effective and overcome the cold-chain storage and distribution problem associated with traditional vaccines. The program will use Lipoxen's liposomal Co-Delivery technology, which combines DNA and protein forms of an antigen in liposomes, and CBL's VitRIS technology, which is designed to generate thermostable formulations. Financial terms were not disclosed.

• Lorus Therapeutics Inc., of Toronto, said it received a $150,000 milestone payment from Zor Pharmaceuticals LLC, a subsidiary of Zoticon Bioventures Inc., raising the first tranche in financing from the development of Virulizin, an immunotherapeutic agent being tested in cancer. That brought the total payment to Lorus to $250,000. Lorus also reported that Central America was added to the territories covered in the exclusive licensing agreement with Zor, which means Lorus will receive an additional $2 million upon achievement of specific development and sales milestones, in addition to royalties. The total potential milestone payment from the deal now exceeds $12 million.

• NeoPharm Inc., of Lake Bluff, Ill., said it signed a Cooperative Research and Development Agreement with the National Institute of Neurological Diseases and Stroke (NINDS) for research on a therapeutic agent for untreatable brain diseases in humans. Under the terms, NINDS will deliver NeoPharm's drug, Cintredekin Besudotox (IL13-PE38QQR) in conjunction with a surrogate marker via NINDS' methodology of Convection Enhanced Delivery. The company will provide both the drug and technical resources to study its effects in various brain cancers in humans. Financial terms were not disclosed.

• Neose Technologies Inc., of Horsham, Pa., said its common stock will be delisted from the Nasdaq Stock Market. The company, which had been notified by Nasdaq in August that its share price had fallen below the minimum requirements for continued listing, agreed last month to sell its assets to partners Novo Nordisk A/S, of Bagsvaerd, Denmark, and BioGeneriX AG, of Mannheim, Germany, in an all-cash deal for $43 million.

• ONI BioPharma Inc., of Alachua, Fla., said it successfully synthesized an antibiotic using its DPOLT technology. That antibiotic is closely related to its lead compound, MU1140, which has the potential to treat infections, including those caused by methicillin-resistant Staphylococcus aureus and other Gram-positive bacteria.

• PharmaCom BioVet Inc., of Raleigh, N.C., entered a collaborative agreement with IsoTherapeutics Group LLC, of Angleton, Texas, to co-develop and introduce therapeutic treatments for companion animals. IsoTherapeutics focuses on radiopharmaceuticals for oncology and is developing technologies to help in the diagnosis and treatment of diseases such as cancer. Terms were not disclosed.

• PharmAthene Inc., of Annapolis, Md., said 2009 appropriations for the Department of Defense include $1.6 million to support ongoing development of the company's broad-spectrum chemical nerve agent countermeasure, Protexia. That funding would be in addition to a multiyear contract, valued at up to $219 million, from the DoD's U.S. Army Space and Missile Command for advanced development of Protexia, a recombinant pegylated version of human butyrylcholinesterase.

• Reata Pharmaceuticals Inc., of Irving, Texas, said the FDA granted RTA 402 orphan drug status in pancreatic cancer. Orphan status provides for regulatory support and would confer seven years of marketing exclusivity upon approval. RTA 402, an antioxidant inflammation modulator, is being studied in a Phase I/II trial in pancreatic cancer and also is in a separate Phase II study in chronic kidney disease.

• Santaris Pharma A/S, of Copenhagen, Denmark, said findings from in vitro and in vivo models, including rodents and nonhuman primates, showed that the company's Locked Nucleic Acid (LNA)-antimiRs demonstrated recognition and detection of disease-associated microRNAs due to their high specificity and affinity. The company said those results showed that the LNA technology is optimal for the development of microRNA antagonists. Data were presented at the Oligonucleotide Therapeutics Society meeting in Boston. Santaris has four ongoing trials of LNA drugs in indications including solid tumors and hepatitis C.

• VGX Pharmaceuticals Inc., of Blue Bell, Pa., said that data from a nonhuman primate study showed significant T-cell-mediated immune responses were generated in reaction to primate analogues of the company's human DNA vaccine candidates, when delivered with the Cellectra device. Monkeys immunized by VGX's vaccines displayed HIV-specific T-cell responses as much as 10 to 20 times greater than those reported in the literature using other vaccine modalities. Data were presented at the AIDS Vaccine 2008 conference in Cape Town, South Africa. VGX recently was awarded a $23.5 million contract by the National Institute of Allergy and Infectious Diseases to develop a preventative HIV DNA vaccine in conjunction with its electroporation technology. (See BioWorld Today, Oct. 2, 2008.)

• Ziopharm Oncology Inc., of New York, said the European Medicines Agency's Committee for Orphan Medicinal Products issued a positive opinion regarding the company's application requesting orphan status for palifosfamide in soft-tissue sarcoma. Orphan designation would guarantee the product 10 years of marketing exclusivity upon approval in the European Union. Palifosfamide, the active moiety of ifosfamide, previously was named an orphan product in the U.S., and is in Phase II testing in combination with doxorubicin in front- and second-line soft-tissue sarcoma.