Panacea Pharmaceuticals' Lung Cancer Diagnostic Test, LC Detect,

December 18, 2007 - Gaithersburg, Maryland - Panacea Pharmaceuticals' lung cancer diagnostic test, LC Detectsm, has been named one of Time Magazine's Ten Biggest Medical Breakthroughs of 2007. LC Detect^sm is a simple blood test to facilitate the identification of lung cancer, even among individuals with early-stage disease... LC Detect^sm measures levels of human aspartyl (asparaginyl) &#beta;-hydroxylase (HAAH), a cancer molecular marker, in blood. HAAH has been detected by immunohistochemical staining in a broad range of cancers, including lung cancer, and has been shown to be highly specific and absent in adjacent non-affected tissue as well as tissue from cancer-free individuals... Panacea's Press Release -

Infinity and Medimmune, Phase 2 Trial of IPI-504 to Assess the Hsp90 Inhibitor’s Potential Anti-Tumor Activity in Patients with Advanced NSCLC

December 19, 2007 – Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) and MedImmune, Inc. announced that the companies have initiated the Phase 2 portion of a Phase 1/2 clinical trial of IPI-504, their lead heat shock protein 90 (Hsp90) inhibitor, in patients with advanced non-small cell lung cancer (NSCLC) ...The goal of this open-label, multi-center clinical trial is to evaluate the anti-tumor activity of IPI-504 in patients with NSCLC... Infinity 's Press Release - MedImmune's Press Release -

Theravance, GSK1160724, Phase 1 Clinical Study With Investigational Medicine For Respiratory Disease

December 12, 2007 - Theravance, Inc. (NASDAQ: THRX) announced that GlaxoSmithKline plc (GSK) initiated subject screening in a Phase 1 clinical study designed to assess the safety, tolerability, and pharmacokinetics of an investigational, inhaled bronchodilator, GSK1160724, for the treatment of chronic obstructive pulmonary disease (COPD)...GSK1160724 is an inhaled, long-acting muscarinic antagonist (LAMA) discovered by Theravance through the application of multivalent drug design in a drug discovery program dedicated to finding new medicines for respiratory diseases such as COPD and asthma... Theravance's Press Release -

Discovery Labs, Aerosurf Improves Lung Function and Reduces Inflammation in a Model of Respiratory Distress Syndrome

December 3, 2007 — ...Aerosurf is an aerosolized formulation of Discovery Lab’s novel KL4 surfactant technology that is delivered non-invasively via novel aerosol generating technology and employs nasal continuous positive airway pressure (nCPAP). Aerosurf, like Discovery’s lead product Surfaxin®, is a precisionengineered synthetic, peptide-containing surfactant which is designed to closely mimic the essential attributes of human lung surfactant.... Discovery Labs' PDF -

Rigel , Initiation of Phase 1 Clinical Trial of R343 for Allergic Asthma by its Partner Pfizer

Dec. 6 , 2007 - Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) announced that its corporate partner, Pfizer (NYSE: PFE), has begun a Phase 1 clinical trial of an inhaled formulation of Rigel's small molecule syk kinase inhibitor, R343, for the treatment of allergic asthma. R343 is the third product candidate in Rigel's clinical portfolio... Rigel's Press Release -

IDM Pharma, IDM-2101 Updated Phase 2 Results Show Treatment Well Tolerated With Positive Survival Trend in Lung Cancer Patients

Nov. 2 - IDM Pharma, Inc. (Nasdaq: IDMI) announced updated results from the Phase 2 study of its investigational agent IDM-2101 which showed the vaccine was well tolerated, induced broadly specific cytotoxic T lymphocyte (CTL) responses, and showed a positive survival trend in patients with non-small cell lung cancer (NSCLC) who were vaccinated with IDM-2101, compared to a parallel external control group of non-vaccinated patients... IDM Pharma's Press Release -

Vectura and Sosei, Phase II Studies of QVA149 for the Treatment of COPD

15 November 2007 - Vectura Group plc (“Vectura”; LSE: VEC) and Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565) announce the start, by Novartis, of a Phase II safety study of QVA149 for the treatment of chronic obstructive pulmonary disease (COPD). QVA149 is a combination of NVA237, a once-daily long-acting muscarinic antagonist (LAMA) and indacaterol, a once-daily long-acting beta-2 agonist (LABA)... Vectura's Press Release - Sosei's Press Release [PDF] -

Aeolus Pharmaceuticals, Pipeline, COPD

November 5, 2007 - ...Chronic Obstructive Pulmonary Disease :
Previously screening of the pipeline compounds indicated that several compounds had potent lung antioxidant and anti-inflammatory effects. These compounds are now scheduled to be examined for in vivo efficacy in a mouse model of lung emphysema induced by chronic cigarette smoke exposure. Studies are expected to start in January 2008 with results due in late summer 2008... [PDF] Aeolus ' Press Release -

Amira Pharmaceuticals, Initiates Clinical Studies for the 2nd Entry Molecule for the Treatment of Respiratory and Cardiovascular Disease

November 1, 2007 - ...AM103 and AM803 are novel inhibitors of 5-lipoxygenase-activiting protein (FLAP) that have demonstrated potential to treat asthma and cardiovascular disease (CVD) by preventing the synthesis of leukotrienes (LT), which trigger inflammation. The recently completed AM103 trial was designed to assess the safety and tolerability of an escalating single dose of the compound and escalating multiple doses in healthy volunteers who received AM103 or placebo for up to 11 days. The trial also assessed the pharmacodynamic properties of AM103, specifically its ability to inhibit LT production... Amira 's Press Release -

NicOx, TOPIGEN initiates phase 2 proof of concept study in COPD for TPI 1020

November 20, 2007 - ...This new clinical study follows the recent announcement of promising top-line results from a phase 2a study in asthmatic smokers, where TPI 1020 showed a good safety and tolerability profile, in addition to certain anti-inflammatory effects which could be potentially beneficial in COPD (see press release of September 11, 2007). COPD is a respiratory disease caused by chronic inflammation of the lungs and bronchi and represents the third-leading cause of death in the United States... [PDF] NicOx' Press Release - PDF en Français - [PDF] Topigen's Press Release -

SPO Medical, New Oximetry Devices for European Markets

November 14, 2007 - ...The PulseOx 6000™ (finger device) and PulseOx 6100™ (hand-held device) are both designed for medical professionals, hospitals and managed care facilities. Based on SPO Medical’s proprietary patented algorithms, both the PulseOx 6000™ and PulseOx 6100™ use Reflective Pulse Oximetry (RPO) technology for accurate and reliable measurements of blood oxygen saturation and heart rate, utilizing new AutoSpot™ technology to read in low profusion measurements. The products have been granted CE Mark of approval by the European Union and will be commercially available early in the first quarter of 2008... [PDF] SPO Medical's Press Release -

Advanced Life Sciences, Cethromycin, Second Pivotal Phase III Trial for Treatment of Pneumonia

Nov. 15, 2007 - Advanced Life Sciences Holdings, Inc. (Nasdaq: ADLS), today announced positive results from Trial CL-05, the second of two pivotal phase III clinical trials designed to assess the safety and effectiveness of cethromycin, a novel once-a-day oral antibiotic for the treatment of mild-to-moderate community acquired pneumonia (CAP), the sixth leading cause of death in the United States... Advanced Life Sciences's Press Release -

Pharmion's Amrubicin, Results Compared to Standard of Care in Second Line Treatment of Small Cell Lung Cancer

Nov. 9, 2007 - Pharmion Corporation (Nasdaq: PHRM) today released interim findings from its Phase 2 trial of Amrubicin in second-line chemo-sensitive small cell lung cancer (SCLC). Amrubicin, the company's third-generation synthetic anthracycline, is a potent topoisomerase II inhibitor currently in development for the treatment of SCLC.... Pharmion's Press Release -

MAP Pharmaceuticals, Phase 2a Clinical Trial of Combination Therapy in Adult Patients with Asthma

Oct 31, 2007 - ...MAP0005 is a combination of a corticosteroid and a long-acting beta2-agonist delivered to the respiratory tract using MAP Pharmaceuticals' Tempo(TM) inhaler. MAP0005 uses the Company's proprietary particle technology to combine the corticosteroid and beta-agonist components into a single drug particle in a fixed, pre-specified ratio. In addition, MAP Pharmaceuticals' technology allows for the particle structure to be specifically designed to target relevant areas in the lung and to release drug at a desired rate. MAP Pharmaceuticals believes that this approach may enable the reproducible and consistent administration of the two drugs in an optimal ratio simultaneously, and may provide improved safety and efficacy over currently available combination therapies for asthma and COPD... MAP Pharmaceuticals' Press Release -

Gilead and LG Life Sciences, Global License Agreement to Advance Novel Drug Candidates for Treatment of Fibrotic Diseases

Nov. 6, 2007- ...Caspases are cellular proteases involved in processes such as apoptosis (cell death) and inflammation. By inhibiting various caspases, it may be possible to slow or stop the progression of fibrosis in the liver for patients with chronic viral hepatitis and non-alcoholic steatohepatitis (NASH), as well as potentially in other fibrotic diseases such as idiopathic pulmonary fibrosis (IPF)... Gilead's Press Release - LG Life Sciences' Press Release -

Æterna Zentaris, Multi-Center Phase 2 Trial with Perifosine in Combination with Radiotherapy for Non-Small Cell Lung Cancer

November 14, 2007 - Æterna Zentaris Inc. (Nasdaq: AEZS TSX: AEZ;), a global biopharmaceutical company focused on endocrine therapy and oncology, announced the completion of patient recruitment for the Company’s European multi-center Phase 2 trial in non-small cell lung cancer (NSCLC) with its novel, first-in-class, oral signal transduction inhibitor, perifosine. This randomized, double-blind, placebo-controlled trial will assess the efficacy and safety of a 150 mg daily dose of perifosine when combined with radiotherapy in 160 patients with inoperable Stage III NSCLC... Æterna Zentaris' Press Release -

Alfacell's ONCONASE, Radiation Sensitizer for Lung Cancer Treatment

Oct. 30 , 2007 -... "ONCONASE significantly reduced the tumor hypertension that is the major physiological barrier of therapeutic delivery to solid tumors," said Dr. Lee. "As a result, ONCONASE increased tumor penetration and selectively increased tumor blood flow. This investigation suggests that ONCONASE may be a new and promising drug in the treatment of non-small cell lung carcinoma patients as a radiation therapy enhancer."... Alfacell's Press Release -

Nabi Biopharmaceuticals, NicVAX(R) , Significant Rates of Smoking Cessation and Continuous Long-Term Smoking Abstinence at 12 Months

Nov. 7, 2007 - ... NicVAX(R) is an innovative and proprietary investigational vaccine being developed by Nabi to treat nicotine addiction and prevent smoking relapse. NicVAX(R) is designed to stimulate the immune system to produce antibodies that bind to nicotine. A nicotine molecule attached to an antibody is too large to cross the blood-brain barrier. Therefore, NicVAX(R) blocks nicotine from reaching its receptors in the brain and prevents the highly-addictive pleasure sensation experienced by smokers and users of nicotine products... Nabi's Press Release -

Forbes Medi-Tech, Final Steps in Compound Selection for Asthma

Tue Oct 30, 2007 - Forbes Medi-Tech Inc. (TSX:FMI and NASDAQ:FMTI) announced that it has entered the final stages of compound selection for two of the most rapidly growing therapeutic indications, asthma and type 2 diabetes... Forbes Medi-Tech's Press Release -

Theravance, Initiation of Phase 2 Clinical Program with its MABA Compound in COPD

October 31, 2007 - Theravance, Inc. (NASDAQ: THRX) announced that GSK has initiated a Phase 2 clinical study of GSK961081, an investigational bifunctional muscarinic antagonist-beta₂ agonist compound for the treatment of chronic obstructive pulmonary disease (COPD)... Theravance's Press Release -

Wyeth, Tygacil for the Treatment of Patients with Community-Acquired Pneumonia

October 24, 2007 — Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE), announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s supplemental New Drug Application (sNDA) for its first-in-class antibiotic Tygacil® (tigecycline) for the treatment of patients with community-acquired pneumonia (CAP)...
Wyeth's Press Release -

Tomophase, First Cross-Sectional Images Of Human Bronchus Using Proprietary OCT System

October 16, 2007 – Tomophase Corporation announced that it will display the first cross-sectional images of excised human bronchial tissue using their proprietary optical coherence tomography (“OCT”) system at the CHEST meeting in Chicago, October 22nd through October 24th... The Tomophase OCT System enables the interventional pulmonologist to clearly visualize sub-epithelial tissue structures in the airway. The system, which is not yet FDA-approved, utilizes a near-infrared emitting probe in a catheter which is integrated with a conventional video bronchoscope... Tomophase' Press Release-

Poniard Pharmaceuticals, Orphan Medicinal Product Designation to Picoplatin for Treatment of Small Cell Lung Cancer

Oct 17, 2007 - Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused on oncology, announced that its lead product candidate, picoplatin, has been granted orphan medicinal product* designation for the treatment of small cell lung cancer (SCLC) by the European Commission. This designation is based on a recommendation from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMEA)... Poniard Pharmaceuticals' Press Release-

Pharmion , Phase 3 Study of Amrubicin in Small Cell Lung Cancer

Oct. 17 , 2007 - Pharmion Corporation (Nasdaq: PHRM) announced the initiation of an international pivotal Phase 3 clinical trial evaluating amrubicin, the Company's third-generation synthetic anthracycline, in the treatment of second-line small cell lung cancer (SCLC). The randomized, controlled, multi-center study will compare amrubicin to topotecan, the only approved chemotherapy for second-line treatment of SCLC in the US and EU. Enrollment in the study of 480 patients is underway... Pharmion's Press Release-

DEY, Clinical Trials for Perforomist™ Inhalation Solution to be Presented at CHEST 2007

October 16, 2007 - Dey, L.P. , a subsidiary of Mylan Inc. (NYSE: MYL), announces three clinical data presentations will be given at CHEST 2007, the annual scientific assembly of the American College of Chest Physicians (ACCP) on Wednesday, October 24, 2007 at the McCormick Place Convention Center in Chicago. Data will be presented from two safety studies that were included as part of the New Drug Application (NDA) filing to the U.S. Food and Drug Administration (FDA) for Perforomist™ Inhalation Solution. The third presents results from a Phase IIIb study of the concomitant use of Perforomist™ Inhalation Solution with tiotropium for the treatment of COPD... Dey's Press Release-

Altair Therapeutics Will Develop Antisense Drugs for Respiratory Conditions

Oct 16, 2007 - Isis Pharmaceuticals, Inc. (Nasdaq: ISIS) and Thomas, McNerney & Partners, LLC, announced that Altair Therapeutics Inc., a new venture capital-funded biotechnology company, has been created to focus on the discovery, development and commercialization of Isis' antisense drugs to treat asthma and other respiratory conditions. Isis has granted an exclusive worldwide license to Altair for the development and commercialization of ISIS 369645, an inhaled inhibitor of the IL-4/IL-13 signaling pathways for the treatment of asthma... Isis' Press Release-

Telik, TELCYTA Clinical Development

October 15, 2007 - Telik, Inc. (Nasdaq: TELK) announced that the U.S. Food and Drug Administration (FDA) has removed the partial hold on TELCYTA^®(canfosfamide HCl, TLK286) clinical trials. This action follows a complete review of TELCYTA data by the agency and permits the resumption of TELCYTA clinical development...TELCYTA, a tumor-activated small molecule product candidate in clinical development for the treatment of advanced ovarian cancer and non-small cell lung cancer... Telik' Press Release-

Abraxis Bioscience, Special Protocol Assessment for Phase III Trial of ABRAXANE in Non-Small Cell Lung Cancer

Oct 15, 2007 - Abraxis BioScience, Inc. (NASDAQ:ABBI), an integrated, global biopharmaceutical company, announced that it has reached a definitive agreement with the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process on the Phase III trial design of the company's pivotal study with ABRAXANE(R) for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin bound) for the treatment of non-small cell lung cancer in the first-line setting... Abraxis BioScience's Press Release-

Critical Therapeutics, Phase III Trial of Zileuton in Patients with Acute Exacerbations of COPD

Oct. 15, 2007- Critical Therapeutics (Nasdaq: CRTX) announced the start of patient enrollment in the LEUKO study, a randomized, double-blind, placebo-controlled efficacy trial to examine the effects of ZYFLO(R) (zileuton tablets) used in the treatment of adults with Chronic Obstructive Pulmonary Disease (COPD). The purpose of this trial is to examine the effectiveness of ZYFLO at reducing the length of a hospital stay for adults who are hospitalized for a COPD exacerbation, or a worsening of their COPD symptoms... Critical Therapeutics' Press Release-

Cellestis, FDA Approval for Blood Test for Detecting Tuberculosis

October 12, 2007 - Physicians & TB controllers around the country can now quickly and accurately detect M. tuberculosis infection with today's U.S. Food and Drug Administration (FDA) approval of QuantiFERON(R)-TB Gold In-Tube (QFT(TM)). This blood test detects cellular immune responses to proteins specifically associated with tuberculosis (TB) infection... Cellectis' Press Release [PDF]-

Threshold Pharmaceuticals would stop enrollment in a Phase 2 clinical trial

Calif., Oct 11, 2007 - Threshold Pharmaceuticals, Inc. (Nasdaq: THLD) announced that, as part of a planned interim analysis, it would stop enrollment in a Phase 2 clinical trial evaluating the efficacy and safety of glufosfamide in patients with recurrent, sensitive small cell lung cancer... Threshold Pharmaceuticals' Press Release-

Oridion, New Smart Capnography System for Improved Patient Safety

October 11, 2007 - Oridion Systems, Ltd. - (SWX: ORIDN) introduces Smart Capnography(TM), a major step forward in improving patient safety. This new launch takes place at this week's American Society of Anesthesiologists in San Francisco, CA. Smart Capnography combines Oridion's most advanced Microstream(R) technology with its new SARA(TM) software for improved alarm management... Oridion's Press Release [PDF]-

Proteolix , Carfilzomib in Subjects with Relapsed Solid Tumors

October 10, 2007 – Proteolix, Inc. and South Texas Accelerated Research Therapeutics (START) announced the enrollment of the first patient in a Phase 1 clinical trial to study Proteolix’s investigational drug, carfilzomib (PR-171)....

...After determining the maximum tolerated dose, additional patients will be enrolled in Phase 2 and stratified according to disease type, including non-small cell lung cancer, small cell lung cancer, ovarian cancer and renal cancer... Proteolix's Press Release -

Nektar Therapeutics, NKTR-102 (PEG-Irinotecan) in Multiple Solid Tumors

Oct 10, 2007 - Nektar Therapeutics (Nasdaq: NKTR) announced that preclinical data for its proprietary product candidate NKTR-102 (PEG-irinotecan) will be presented at the upcoming AACR-NCI-EORTC International Conference on Molecular Targets and Therapeutics in San Francisco, California on October 25, 2007. The presentations will highlight new results from preclinical trials of NKTR-102 in mouse models of colorectal, lung and breast cancers... Nektar's Press Release-

Broncus Technologies, Encouraging Results Reported on Airway Bypass Procedure , Exhale Drug-Eluting Stent

October 9, 2007 - Broncus Technologies, Inc., a medical device company investigating the airway bypass procedure for the treatment of emphysema, announced that the results of its open-label Exhale® Drug-Eluting Stent feasibility study have been published in the October issue of the Journal of Thoracic and Cardiovascular Surgery. Positive results include a statistically significant reduction in the amount of air trapped in the lungs and an improvement in breathing for patients at six months after the airway bypass procedure... Broncus' Press Release-

Exelixis, Phase II study of XL647 in Patients with Non-Small Cell Lung Cancer

Calif., Oct. 8 , 2007 - Exelixis, Inc. (Nasdaq: EXEL ) announced that data from ongoing phase 2 trials of XL880 and XL647 in papillary renal cell carcinoma and non-small cell lung cancer, respectively, will be presented at the 2007 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, which will be held October 22-26, 2007 in San Fran cisco... Exelixis' Press Release -

MediciNova Positive Phase IIa Clinical Study Results for MN-221, a Novel Treatment for Status Asthmaticus

Oct 9, 2007 - MediciNova, Inc., a biopharmaceutical company that is publicly traded on the Nasdaq Global Market (Nasdaq:MNOV) and the Hercules Market of the Osaka Securities Exchange (Code Number: 4875), announced positive results from a Phase IIa clinical study of MN-221, its novel intravenous product candidate for the treatment of status asthmaticus* (acute severe asthma attack)... MediciNova's Press Release -

PTC Therapeutics, Phase 2 Results of PTC124 in Cystic Fibrosis

October 5, 2007 - PTC Therapeutics, Inc. (PTC), a biopharmaceutical company focused on the discovery, development and commercialization of small-molecule drugs targeting post-transcriptional control mechanisms, today announced encouraging data from a Phase 2 clinical trial of PTC124 in pediatric patients with cystic fibrosis (CF) due to a nonsense mutation... PTC Therapeutics' Press Release -

Inspire, Phase 3 Cystic Fibrosis Trial

Oct. 4, 2007--Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) announced that it has completed patient enrollment in TIGER-1, the first of two planned pivotal Phase 3 clinical trials with denufosol tetrasodium inhalation solution for the treatment of cystic fibrosis*(CF)... Inspire's Press Release -

MedImmune , Phase 2 Safety Data for Anti-RSV Antibody and National RSV Surveillance Results

Oct. 4 /PRNewswire/ -- MedImmune, Inc. announced results from two important studies presented at the 2007 Infectious Diseases Society of America (IDSA) 45th Annual Meeting adding to the body of knowledge about respiratory syncytial virus* (RSV). RSV is a viral pathogen that produces annual outbreaks usually between fall and spring. While RSV typically manifests cold-like symptoms in healthy children, it can prove to be a very serious respiratory illness for premature infants and is the leading cause of respiratory infections for newborns each year... MedImmune 's Press Release -

Gilead, Phase III Study of Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis

Oct. 4, 2007--Gilead Sciences, Inc. (Nasdaq:GILD) announced detailed results of its Phase III AIR-CF1 (CP-AI-007) study of aztreonam lysine for inhalation, an investigational therapy in development for the treatment of people with cystic fibrosis* (CF) who have pulmonary Pseudomonas aeruginosa (P. aeruginosa). In this study, a 28-day treatment course of aztreonam lysine improved respiratory symptoms as assessed by the Cystic Fibrosis Questionnaire-Revised (CFQ-R), a patient-reported outcome (PRO) tool. Aztreonam lysine also improved pulmonary function in this study, as measured by relative improvement of forced expiratory volume in one second (FEV1), a standard measure of lung function... Gilead's Press Release -