ArQule, Phase 1/2 Clinical Trial Program of ARQ 197 in Non-Small Cell Lung Cancer

March 13, 2008--ArQule, Inc. (NASDAQ: ARQL) announced the commencement of patient dosing in a Phase 1/2 clinical trial program of ARQ 197 administered in combination with erlotinib in patients with advanced non-small cell lung cancer (NSCLC). ARQ 197 is an orally available, small molecule inhibitor of the c-Met receptor tyrosine kinase. Erlotinib, marketed as Tarceva(R), is an inhibitor of the EGFR (epidermal growth factor receptor) tyrosine kinase... ArQule's Press Release -

Novelos Therapeutics, Pivotal Phase 3 Lung Cancer Trial

March 13, 2008 - -Novelos Therapeutics, Inc. (OTCBB: NVLT), a biopharmaceutical company focused on the development of therapeutics to treat cancer and hepatitis, today announced that Novelos has reached the target enrollment of 840 patients in the pivotal Phase 3 trial in advanced non-small cell lung cancer (NSCLC) for its lead product NOV-002 in combination with first-line chemotherapy... [PDF] Novelos' Press Release -

Abbott, Genentech, Roche and OSI, Collaboration on Molecular Test for Lung Cancer Therapy Response

March 7, 2008 -Abbott's FISH Technology Provides Analytical Tool with Potential to Assess Clinical Response to Lung Cancer Treatment in Patients with Non-Small-Cell Lung Cancer - Abbott (NYSE: ABT) announced that its molecular diagnostics business has entered into an agreement with Genentech, Inc., F. Hoffmann-La Roche Ltd. and OSI Pharmaceuticals, Inc. to develop a gene test to potentially assess the clinical benefit of Tarceva® (erlotinib), an oral tablet indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen. Under the agreement, Abbott will develop a test to detect extra copies of the epidermal growth factor receptor (EGFR) gene using its proprietary fluorescence in situ hybridization (FISH) technology in NSCLC... Abbott's Press Release -

Luminex and Abbott, Agreement for Global Distribution of the xTAG Respiratory Viral Panel

02/28/08 - Luminex Molecular Diagnostics, a division of Luminex Corporation (NASDAQ: LMNX), the worldwide leader in multiplexing solutions, has signed a global sales and distribution agreement with Abbott's (NYSE: ABT) molecular diagnostics business. Under the terms of the agreement, Abbott will have exclusive rights to distribute Luminex's new xTAGTM Respiratory Viral Panel (RVP) worldwide outside the United States and semi-exclusive rights in the United States.

Based on Luminex's xMAP® multiplexing technology, xTAG RVP was created by Luminex Molecular Diagnostics, in partnership with a team of leading virologists and infectious disease specialists. In a matter of hours from a single patient sample, the test allows doctors to detect the presence or absence of several viruses and subtypes at once... Luminex's Press Release -

Quidel's QuickVue RSV Test : FDA Grants CLIA Waiver

Feb. 29, 2008--Quidel Corporation (NASDAQ:QDEL), a leading provider of rapid point-of-care (POC) diagnostic tests, announced that the U.S. Food and Drug Administration (FDA) granted CLIA waiver for the QuickVue(R) RSV test for the qualitative detection of respiratory syncytial virus (RSV). The waiver makes the QuickVue RSV test more widely available for use, especially in physician offices and clinics where waived tests are used most frequently. The QuickVue RSV test is simple and accurate, with high sensitivity and specificity.

Respiratory syncytial virus is recognized by the American Academy of Pediatrics as the leading cause of pneumonia and bronchiolitis among children two years of age and younger. RSV is a common virus with symptoms that often resemble the common cold.(1) The QuickVue RSV test is intended for use as an aid in the diagnosis of acute RSV viral infections for symptomatic pediatric patients... Quidel's Press Release -

Altor BioScience , Tissue Factor Antagonists from Genentech

February 12, 2008 - Altor BioScience Corporation (Altor) announced it has entered into an agreement with Genentech, Inc. for exclusive, worldwide rights to develop and commercialize a class of antibody-based Tissue Factor antagonists. Altor plans on initiating a multi-center, Phase II clinical study later this year, using the lead therapeutic antibody known as ALT-836 for the treatment of Acute Respiratory Distress Syndrome (ARDS) and Acute Lung Injury (ALI)... Altor BioScience's Press Release -

Introgen's p53 Immunotherapy INGN 225 in Patients with Small Cell Lung Cancer

Feb. 13, 2008--Introgen Therapeutics, Inc. (NASDAQ:INGN) and Moffitt Cancer Center today announced that a randomized, controlled study of INGN 225, Introgen's immunotherapy product has been initiated in patients with metastatic small-cell lung cancer (termed extensive stage SCLC).

Introgen and Moffitt previously announced that the National Institutes of Health National Cancer Institute awarded a grant of approximately $1.3 million to fund the trial based upon the promising results of previous clinical studies in small-cell lung cancer patients.
INGN 225 is a p53 immunotherapy using a patient's own cells to stimulate an anti-tumor immune response to fight cancer. The immunotherapeutic targets the p53 tumor suppressor molecular abnormality found in over half of all solid cancers... Introgen's Press Release -

Inspire, Second Phase 3 Cystic Fibrosis Trial

Feb 13, 2008 - Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) announced today the initiation of TIGER-2, its second pivotal Phase 3 clinical trial with denufosol tetrasodium inhalation solution for the treatment of cystic fibrosis (CF).

TIGER-2 (Transport of Ions to Generate Epithelial Rehydration) is a 24-week, double-blind, placebo-controlled, randomized study comparing 60 mg of denufosol inhaled three times daily to placebo in approximately 350 CF patients with FEV1 (Forced Expiratory Volume in one second) greater than or equal to 75% of predicted normal. The trial's primary efficacy endpoint is change from baseline in FEV1 (liters) at the 24-week timepoint. Secondary endpoints include other lung function parameters, pulmonary exacerbations, requirements for concomitant CF medications and quality of life... Inspire's Press Release -

Expression Pathology, Research in Identifying Biomarkers of Lung Cancer Metastasis and Survival

February 19, 2008 - Expression Pathology Inc. (EPI), a leader in tissue proteomics, announced that researchers at Tokyo Medical University, using the company’s tissue microproteomics technologies, identified protein biomarkers associated with lung cancer metastasis, which were further studied for correlation to clinical outcomes. The researchers used EPI’s Liquid Tissue® reagents and Director™ laser microdissection slides to analyze formalin-fixed paraffin-embedded (FFPE) tissue samples by mass spectrometry... [PDF] Expression Pathology's Press Release -

Biothera’s Imprime PGG with Avastin Against Cancer

February 28, 2008 – Biothera’s Imprime PGG™ increased the effectiveness of Avastin® (bevacizumab), a monoclonal antibody approved for the treatment of metastatic colorectal, breast and non-small cell lung cancer, according to a new preclinical study published in the current issue of Clinical Cancer Research.

Researchers in the Tumor Immunobiology Program of the James Graham Brown Cancer Center, University of Louisville, Kentucky, studied the synergistic effects of Imprime PGG in combination with Avastin in a xenograft mouse model where human ovarian cancer cells were implanted into the mice. In the treatment group receiving both Imprime PGG and Avastin, 86% of the mice survived 100 days compared with only 43% in the group receiving Avastin alone... Biothera 's Press Release -

Response Genetics, ResponseDX Tests to Select Institutions

March 5, 2008 - Response Genetics, Inc. (NASDAQ: RGDX) announced that its ResponseDX: Lung™ and ResponseDX: Colon™ tests are now available to select medical institutions and practice groups through its CLIA-registered laboratory. ResponseDX: Lung™ and ResponseDX: Colon™ are PCR-based tests that help guide therapeutic treatment decisions in patients with non-small cell lung cancer (NSCLC) and colorectal cancer (CRC). The tests are in their initial launch phase and are available only to pre-qualified institutions at this time... Response Genetics' Press Release -

Gilead, Aztreonam Lysine 75 mg Powder for Nebuliser Solution, a Potential New Treatment for Cystic Fibrosis

Mar 07, 2008 - Gilead Sciences, Inc. (Nasdaq:GILD) announced the submission of a Marketing Authorisation Application (MAA) for marketing approval of aztreonam lysine 75 mg powder for nebuliser solution (aztreonam lysine) in the European Union. The MAA will be reviewed by the Committee for Medicinal Products for Human Use (CHMP), subject to validation by the European Medicines Agency (EMEA). Review of the MAA will be conducted by the EMEA under the centralized licensing procedure, which, when finalized, provides one marketing authorization in all member states of the European Union. Aztreonam lysine is an investigational therapy in development for people with cystic fibrosis (CF) who have pulmonary Pseudomonas aeruginosa (P. aeruginosa) infection. Aztreonam lysine 75 mg powder for nebuliser solution is administered using an eFlow(R) Nebuliser (PARI GmbH)... Gilead Sciences' Press Release -

Alnylam, First Human Proof of Concept for an RNAi Therapeutic with GEMINI Study

Feb 29, 2008 - Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced that it has achieved human proof of concept with an RNAi therapeutic, a first for the industry. Results from the company's GEMINI trial with ALN-RSV01, an RNAi therapeutic for the treatment of respiratory syncytial virus (RSV), showed statistically significant anti-viral efficacy. In the Phase II experimental infection study, treatment with ALN-RSV01 led to a decreased RSV infection rate, an increase in the number of subjects who remained free of infection, and was safe and well tolerated. Results from GEMINI are being presented at the International Symposium on Respiratory Viral Infections in Singapore... Alnylam's Press Release -

Aerocrine, NIOX MINO: a New Hand-Held Device to Measure Airway Inflammation in Asthma

4 March, 2008 - NIOX MINO® Set to Dramatically Improve Airway Inflammatory Disease Management through Personalized Inflammation Control.
Aerocrine, Inc. (STO:AEROB) announced that NIOX MINO, a hand-held point-of-care device for the measurement of airway inflammation, has been 510(k) cleared by the U.S. Food and Drug Administration (FDA). Physicians in the U.S. now have a highly accurate, non-invasive and convenient technology that is appropriate for use in a doctor’s office, ultimately helping them improve how they treat asthma patients.NIOX MINO provides accurate, reproducible and immediate measurement of fractional exhaled nitric oxide (FENO), a validated method for assessing asthma-related airway inflammation. NIOX MINO is the first hand-held device to measure airway inflammation—an underlying cause of inflammatory airway diseases—helping physicians improve patient outcomes and reduce healthcare expenditures... [PDF] Aerocrine's Press Release -