• Achillion Pharmaceuticals Inc., of New Haven, Conn., reported positive safety and efficacy results from its ongoing Phase I trial studying elvucitabine in patients infected with HIV. Elvucitabine is an L-cytosine nucleoside analogue reverse transcriptase inhibitor (NRTI). The results at 48 weeks demonstrated that elvucitabine had a substantial anti-viral effect similar to 3TC, with a mean change in HIV-RNA from baseline in the elvucitabine treatment group of -3.0 log10 (+/-0.55) vs. -3.2 log10 (+/- 0.6) in the 3TC treatment group in the as-treated patient analysis. In the elvucitabine-treated group, 96 percent of patients reached undetectable viral load compared to 97 percent in the 3TC group. Elvucitabine was well tolerated and demonstrated a safety profile comparable to 3TC for both incidence and severity of adverse events.

• ALK-Abelló, of Barcelona, Spain, presented successful results from a new clinical trial, GT-12, to measure the impact of Grazax on allergic rhinitis and allergic asthma. The study compared the effects of Grazax with symptomatic medication vs. symptomatic medication alone on the ability to reduce symptoms of allergic rhinitis and seasonal asthma. Grazax reduced the combined asthma symptom score by 64 percent. The asthma symptoms included coughing, wheezing, chest tightening/shortness of breath and exercise-induced symptoms. Participants in the study also experienced a 67 percent reduction in the number of days with asthma symptoms.

• Biogen Idec, of Cambridge,Mass., said the Cancer and Leukemia Group B reported data from a Phase II trial showing that 70 percent of patients with previously untreated follicular lymphoma responded to treatment with galiximab, an investigational anti-CD80 monoclonal antibody, when given in combination with rituximab. Of the 61 patients in the study, 44 percent achieved a complete response and 26 percent had a partial response. The results suggested that adding galiximab to rituximab may be a promising regimen for patients with follicular lymphoma, a common type of non-Hodgkin lymphoma, and that further study is warranted. The objective of the CALGB-coordinated study is to determine the overall response rate and time to progression of the disease after treatment with a combined regimen of galiximab and rituximab. The data were presented at the International Conference on Malignant Lymphoma in Lugano, Switzerland.

• Cell Therapeutics Inc., of Seattle, presented positive data of investigational regimen combining rituximab-CHOP or R-CHOP with 90Yttrium Ibritumomab Tiuxetan or Zevalin radioimmunotherapy treatment in elderly patients with high risk previously untreated diffuse large B-cell lymphoma or DLBCL, a cancer of the white blood cells. Of the 63 elderly patients in the age group of 62-86 years enrolled in the study, 39 treated with Zevalin showed a progression-free rate of 78 percent and an overall survival rate of 82 percent.

• Cel-Sci Corp., of Vienna, Va., and researchers at Northeastern Ohio Universities Colleges of Medicine and Pharmacy demonstrated that immunization with a Cel-Sci's LEAPS (Ligand Epitope Antigen Presentation System) vaccine altered the immunological hormone (cytokine) balance toward a Th1 environment. A Th1 cellular immune response is needed for protection against many viral diseases. The LEAPS vaccines that were examined include one that previously was shown to provide antigen specific protection and cellular immunity against herpes simplex virus infection via interferon gamma in mouse models of human disease and another that is directed against a HIV protein.

• Cerus Corp., of Concord, Calif., announced results from 32 studies on the Intercept Blood System. Study outcomes included clinical experience implementing the Intercept Blood System for platelets and plasma into routine practice. Other studies demonstrated its usefulness in the inactivation of current and emerging pathogens, such as malaria and avian influenza, in donated blood, the company said. The safety and efficacy also were highlighted in results from a multiyear hemovigilence surveillance program and in a study of patients with a severe congenital bleeding disorder undergoing major surgery. The studies were presented at the International Congress of the International Society of Blood Transfusion in Macao SAR, China.

• Idera Pharmaceuticals Inc., of Cambridge, Mass., said that its novel Toll-like receptor (TLR) antagonist candidate showed significant anti-inflammatory activity in ovalbumin (OVA)-induced lung inflammation in mice compared to mice treated with OVA alone. The results suggested that TLR antagonists may have potential in the treatment of lung inflammatory diseases. In a separate study evaluating a TLR antagonist candidate in a mouse model of psoriasis induced by administration of recombinant murine IL-23, it was shown that the TLR antagonist showed dose-dependent reductions in markers of IL-23-induced psoriasis, and IL-6 induction in dermal tissues, compared to mice treated with IL-23 alone.

• ImmuneRegen BioSciences Inc., of Scottsdale, Ariz., said additional study results confirmed the effects of its compound Homspera in stimulating the development of human adult stem cells. The results showed Homspera's ability to enhance formation of early stage blood cells from adult hematopoietic (blood-forming) stem cells. The studies were repeated with cells isolated from multiple human bone marrow donors to account for donor variability. Homspera stimulated stem cell differentiation of both myeloid precursors (red blood cells, platelets and granulocytic white blood cells) and lymphoid precursors (T- and B cells).

• Marshall Edwards Inc., of New Canaan, Conn., which is majority owned by Novogen Ltd., of North Ryde, Australia, said an independent data monitoring committee recommended continuation of the Phase III trial of phenoxodiol plus carboplatin. The drug is being studied in women with advanced ovarian cancer resistant or refractory to platinum-based drugs, to determine its safety and effectiveness when used in combination with carboplatin. The study now can continue with its goal for enrollment of 340 patients.

• Medivation Inc., of San Francisco, said it has begun dosing in its second pivotal Phase III trial of the investigational drug Dimebon in patients with mild-to-moderate Alzheimer's disease. Known as the CONNECTION study, the trial can be used with a previously completed pivotal trial to support the approval of Dimebon for Alzheimer's disease. Medivation expects to complete the study and apply for U.S. and European marketing approval in 2010. The study will evaluate the safety and efficacy of Dimebon in combination with Aricept (donepezil HCI tablets), an FDA-approved Alzheimer's treatment.

• Neoprobe Corp., of Dublin, Ohio, started a Phase III study of Lymphoseek in patients with either breast cancer or melanoma. The study is designed to evaluate Lymphoseek in identifying lymph nodes that might be predictive of determining whether a patient's cancer has spread to the lymphatic system. The company is awaiting final clearance for a second Phase III trial in patients with head and neck squamous cell carcinoma. Pending positive results from both studies, the company aims to seek marketing approval in the first half of next year.

• Nymox Pharmaceutical Corp., of Hasbrouck Heights, N.J., said it is starting a Phase III program for NX-1207 in benign prostatic hyperplasia to support a new drug application. The company said further program details will be provided prior to the start of pivotal trials.

• Peptimmune Inc., of Cambridge, Mass., said results from a Phase Ia trial of second-generation peptide copolymer PI-2301 showed that all doses were safe and well tolerated and demonstrated early immunological effects consistent with the drug's pharmacologic mechanism of action. Those data were presented at the European Neurological Society meeting in Nice, France, and at the Federation of Clinical Immunology Societies meeting in Boston.

• Pharmacyclics Inc., of Sunnyvale, Calif., announced results from a preclinical study evaluating PCI-32765, an orally available, selective inhibitor of Bruton's tyrosine kinase (Btk), in collage-induced arthritis in an animal model of rheumatoid arthritis. Btk is a critical enzyme involved in B-cell activation and mast cell function, and inhibition of its function may be useful in the treatment of immune-mediated diseases. Treatment with PCI-32765 prevented further joint swelling when animals were dosed at early stages of disease. It also was shown to reduce inflammation and to induce regression of disease after only five days of dosing in animals with advanced disease. PCI-32765 also inhibited the proliferation of, and induced apoptosis in, multiple B-cell lymphoma cell lines in vitro, suggesting that Btk inhibition could be a novel drug target in lymphoma.

• Vertex Pharmaceuticals Inc., of Cambridge, Mass., reported that 52 percent of patients with genotype 1 hepatitis C patients who were treated with a telepravir-based therapy saw a sustained virologic response at 12 weeks post-treatment. Based on the interim data, Vertex and Belgium-based partner Tibotec plan to initiate a Phase III trial in patients who have failed prior treatment with peg-IFN and RBV.

• XOMA Ltd., of Berkeley, Calif., said that its lead drug candidate XOMA 052 significantly reduced the bone and cartilage destruction caused by collagen-induced arthritis and effectively prevented and treated disease as assessed by a standard measure of inflammation and swelling in a study in the mouse model of rheumatoid arthritis. XOMA 052, a monoclonal antibody that binds strongly to a pro-inflammatory cytokine interleukin-1 beta (IL-1 beta), acts by blocking the activation of the IL-1 receptor, and thereby preventing the cellular signaling events that produce inflammation. The placebo-controlled study of XOMA 052 in mice with collagen-induced arthritis showed that it neutralizes mouse and human IL-1 beta in vivo and in vitro.