M. D. Anderson and Aureon Laboratories : to Evaluate Biomarkers Associated with Non-Small Cell Lung Cancer

June 9, 2008 - Aureon Laboratories, Inc. announced a collaborative research effort with Dr. Ignacio Wistuba, associate professor of pathology at The University of Texas M. D. Anderson Cancer Center. The goal of the study will be to quantitate and evaluate biomarkers that are associated with progression of disease and overall survival. The project will apply Aureon’s systems pathology platform for the analysis of tissues from approximately 350 non-small cell lung cancer (NSCLC) patients.
Aureon’s systems pathology platform applies morphometric imaging to formalin-fixed, paraffin-embedded (FFPE) tissue specimens, enabling quantitation and integration of histological attributes and multiplexed protein biomarkers on a cell-by-cell basis. Additionally, Aureon has developed a multivariate algorithm that integrates histological, molecular, and clinical features to establish a comprehensive biometric signature associated with patient outcome. This approach allows for an analysis of histological and molecular information extracted from intact tissue specimens resulting in the identification of phenotypes associated with disease course... Aureon Laboratories' Press Release -

Aradigm : Phase 2 Study of Inhaled Liposomal Ciprofloxacin in Bronchiectasis

June 19, 2008- Study Will Explore New Treatment of a Severe Respiratory Disease Condition with Unmet Medical Need -Aradigm Corporation (OTCBB: ARDM) (the "Company") announced it has initiated a multicenter Phase 2 clinical trial of its inhaled liposomal ciprofloxacin in adult patients with non-cystic fibrosis bronchiectasis.

Following an antibiotic washout period, 36 patients will be enrolled to receive daily inhaled liposomal ciprofloxacin for a period of 28 consecutive days. The primary efficacy endpoint will be treatment of respiratory infection measured as the change in the density of Pseudomonas Aeruginosa bacterial colony forming units (CFU) in the sputum over the treatment period. Secondary endpoints will include pulmonary function measurements and respiratory symptoms. The study is being conducted in leading bronchiectasis centers in the United Kingdom... Aradigm's Press Release -

Alnylam and Kyowa Hakko : Alliance for the Development and Commercialization of

June 19, 2008 -Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY -) and Kyowa Hakko Kogyo Co., Ltd. (TSE: 4151 - ) today announced that they have formed an exclusive alliance to develop and commercialize ALN-RSV01, an RNAi therapeutic in Phase II clinical development by Alnylam for the treatment of respiratory syncytial virus (RSV) infection, in Japan and other major markets in Asia... Alnylam's Press Release -

Kyowa Hakko Kogyo's Press Release -

Altus Pharmaceuticals : Last Patient Visit Of Trizytek Phase 3 Efficacy Trial

June 13, 2008 -- Altus Pharmaceuticals Inc. (NASDAQ: ALTU), a biopharmaceutical company focused on oral and injectable protein therapeutics for gastrointestinal and metabolic disorders, announced the completion of the last patient visit of the Trizytek Phase 3 efficacy trial. In this trial, Altus is evaluating the efficacy of an oral, non-porcine enzyme replacement therapy for cystic fibrosis patients with exocrine pancreatic insufficiency. Derived from recombinant technology, Trizytek (porcine-free enzymes) is a consistent, stable and pure combination of three active enzymes in a fixed-ratio that is designed to improve fat, protein and carbohydrate absorption in pancreatic insufficient individuals... Altus Pharmaceuticals' Press Release -

Transave : POSITIVE PHASE II RESULTS FOR ONCE-DAILY ARIKACE™ IN THE TREATMENT OF CYSTIC FIBROSIS PATIENTS WHO HAVE PSEUDOMONAS LUNG INFECTIONS

June 13, 2008 – Transave, Inc., reported positive results from a Phase II clinical trial on its lead investigational drug, Arikace™ (liposomal amikacin for inhalation). The compound is being developed for the treatment of cystic fibrosis (CF) patients who have lung infections due to the bacterium Pseudomonas aeruginosa. The Phase II data indicated that Arikace, delivered once daily for 28 consecutive days, produced a significant improvement in lung function, was well-tolerated, and had a side-effect profile comparable to placebo. The Phase II trial was a randomized, double-blind, placebo-controlled study of 64 patients from 15 centers in Europe... Transave's Press Release -

Gilead : Interim 12-Month Phase III Study Results for Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis

Jun 13, 2008 - Gilead Sciences, Inc. (Nasdaq:GILD) announced results from an interim analysis of 12-month data from its open-label, Phase III AIR-CF3 (006) 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). AIR-CF3 is an ongoing, multi-center study designed to evaluate the safety of repeated exposure to aztreonam lysine in cystic fibrosis patients who originally participated in the pivotal Phase III AIR-CF1 (007) or AIR-CF2 (005) studies... Gilead's Press Release -

Pharmacopeia and GlaxoSmithKline Collaboration : a New Lead Compound

Jun 04, 2008 - Pharmacopeia (NASDAQ: PCOP), an innovator in the discovery and development of novel small molecule therapeutics, announced that it has identified a new lead compound for advancement in its alliance with GlaxoSmithKline (NYSE: GSK), through its collaboration with the Center of Excellence for External Drug Discovery (CEEDD). This newly identified lead compound is the second from a program being evaluated as a potential treatment for respiratory disease.
As a result of this identification, Pharmacopeia received a $500,000 milestone payment from GSK... Pharmacopeia's Press Release -

Banner Pharmacaps : FDA Approval for Amantadine Softgel Capsules

June 2, 2008 - Banner Pharmacaps Inc., a leader in the pharmaceutical industry for the development of soft gelatin dosage form technology, announces that the US Food & Drug Administration granted approval for the Company's Abbreviated New Drug Application (ANDA) for Amantadine Hydrochloride USP 100 mg soft gelatin capsules on May 29, 2008. Amantadine is indicated for the prophylaxis and treatment of signs and symptoms of infection in the respiratory tract caused by various strains of influenza A virus... [PDF] Banner Pharmacaps' Press Release -

ImmunoCellular Therapeutics : Research Agreement with George Mason University for Detection of Certain Cancers

June 19, 2008 - ImmunoCellular Therapeutics, Ltd. (OTC: IMUC.OB) (IMUC), a biotechnology company, today announced that the company has signed a research agreement with George Mason University for the development of a blood test to detect small cell lung cancer and pancreatic cancer using IMUC's monoclonal antibody technology. The blood-based test would be designed to look for certain markers for the cancers potentially allowing for early detection of these cancers as well as assisting the selection of patients most likely to respond to the company's monoclonal antibody therapy, ICT-109... ImmunoCellular Therapeutics' Press Release -

Vitrolife : STEEN Solution approved for sales in Australia

2008-06-18 - Vitrolife’s product STEEN Solution™ is part of a new method for functional testing and preservation of lungs outside the body. The technology makes it possible for the first time to test the function of donated lungs outside the body by pumping STEEN Solution™ into the organ’s system of vessels before possible use...
With the STEEN Solution™ method, the number of potential organs that can be transplanted increases considerably. In the USA, for example, less than 20 percent of the lungs donated are transplanted today, due to uncertainty about the function of the organ. In time the STEEN Solution™ method can lead to a fivefold to tenfold increase in the number of lung transplantations carried out, as the need for donated organs using today’s methods considerably exceeds supply. So far 8 transplantations have been performed using this method, all at the University Hospital of Lund... Vitrolife’s Press Release -

Pharmaxis : Special Protocol Assessment with FDA for Bronchitol Phase 3 Trial

20.06.2008 - Pharmaxis (ASX: PXS, Nasdaq: PXSL) announced that the company and the U.S. Food and Drug Administration (FDA) have reached agreement on the phase 3 registration trial of Bronchitol for bronchiectasis via the Special Protocol Assessment process.
The SPA process allows for FDA evaluation of a clinical trial protocol intended to form the primary basis of an efficacy claim in support of a New Drug Application, and provides an agreement that the study design, including trial size, clinical endpoints and/or data analyses are acceptable to the FDA.
Pharmaxis previously agreed on the trial design with the European regulatory agency (EMEA). This trial will therefore form the basis of a marketing application in both the U.S. and Europe.
The phase 3 trial has been designed in collaboration with internationally renowned experts in the field of bronchiectasis and will be a randomized, placebo controlled, double‐blind investigation o Bronchitol twice daily in approximately 350 adults with bronchiectasis. Participants will be treated for 52 weeks and the primary endpoints are reduction in frequency of exacerbations and improvement in quality of life. Secondary endpoints include time to first exacerbation and duration of exacerbation. Additional secondary endpoints are antibiotic use, sputum volume, exercise tolerance and lung function measurements. The trial includes health economic analysis and will be conducted in centers across Europe and the U.S... [PDF] Pharmaxis' Press Release -

FASgen : Production and Investment Agreement with Tetracore

May 29, 2008 - FASgen Diagnostics, LLC (Baltimore) and Tetracore, Inc. (Rockville) have announced that they have entered into a collaboration to produce cGMP ELISA and IHC tests for cancer biomarkers using FASgen's proprietary antibodies. The tests measure the over-expression of the enzyme fatty acid synthase (FAS), which is found in virtually all solid tumor cancers. FASgen's FAS-detect(TM) Elisa and FAS-detect(TM) IHC tests, currently available for research purposes, have demonstrated repeated and highly significant success in identifying the progression of the disease in a series of different solid tumors, including, pancreas, ovarian, prostate and lung cancer.
These research results were recently the subject of multiple independent papers and presentations at the AACR annual meeting and at the earlier annual meeting of the Society of Gynecological Oncologists... FASgen Diagnostics' Press Release - Tetracore's Press Release -

Vall d’Hebron University Hospital and Cyclacel Pharmaceuticals to initiate Phase 1 combination study of Seliciclib and Tarceva

May 29, 2008 – Vall d’Hebron University Hospital and Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP) announced a collaboration to conduct a Phase 1 study of investigational therapy seliciclib in combination with erlotinib (Tarceva®) in patients with advanced solid tumors including non-small cell lung cancer (NSCLC). Seliciclib, Cyclacel’s orally available cyclin dependent kinase (CDK) inhibitor, has shown encouraging anti-cancer activity in several Phase 1 and Phase 2 studies. Seliciclib is currently being tested as a single agent in the treatment of patients with non-small cell lung cancer in the Phase 2b APPRAISE trial and in a Phase 2 study in patients with nasopharyngeal cancer... Cyclacel Pharmaceuticals' Press Release -

Ikaria : INOFLO (NITRIC OXIDE) FOR INHALATION TO BE OFFICIALLY APPROVED IN JAPAN

June 18, 2008 – Ikaria Holdings, Inc., through its subsidiary INO Therapeutics LLC, announced today that Japan’s Ministry of Health, Labor, and Welfare’s Council on Drugs and Food Sanitation (CDFS) has recommended approval of INOflo (nitric oxide) for inhalation. INOflo (brandname INOmax® in the United States) will be indicated for the treatment of newborns who suffer from hypoxic respiratory failure (HRF), a potentially life-threatening condition that keeps babies’ lungs from delivering enough oxygen to their bodies. INOflo is expected to be officially approved by Japan’s Ministry of Health, Labor and Welfare (MHLW) in July 2008... [PDF] Ikaria's Press Release -

Boehringer Ingelheim : to acquire Actimis Pharmaceuticals

17 June 2008 - Boehringer Ingelheim GmbH announced an agreement to acquire Actimis Pharmaceuticals, Inc., a privately owned biotech company based in San Diego. The acquisition will occur through a structured buyout in which Boehringer Ingelheim will acquire shares of Actimis depending on the achievement of several successive milestones with Actimis’ leading asthma compound AP768. If AP768, currently in phase I clinical development, is successfully advanced into a phase III, Boehringer Ingelheim will own 100% of Actimis’ shares.

Upon successful completion of the entire development programme, the total deal will be worth US$ 515 million. Further financial details were not disclosed... Boehringer Ingelheim's Press Release -

SkyePharma : Second Flutiform Phase III Efficacy Study Meets Primary Endpoints

17 June, 2008 - SkyePharma PLC (LSE: SKP) announces that its second Phase III efficacy study evaluating Flutiform™ for the treatment of moderate to severe asthma in adolescent and adult patients has met its primary endpoints. This is the second of several clinical efficacy studies being carried out in preparation for regulatory filing.
The study (SKY2028-3-004) was conducted in centres across the United States and Europe. The full analysis set includes a total of 557 patients. The study was a randomised, double-blind, placebo-controlled, parallel group, stratified, multi-centre study comparing the safety and efficacy of fluticasone and formoterol combination (Flutiform™ 100/10μg or 250/10μg twice daily) in a single inhaler (SkyePharma HFA pMDI) versus the administration of either placebo or fluticasone (250μg twice daily) or formoterol (10μg twice daily) alone in adolescent and adult patients with moderate to severe asthma. Patients were treated for 12 weeks after initial screening and a 14 day run-in period... SkyePharma's Press Release -

ALK-Abelló : GRAZAX® Demonstrates Significant Reductions on Asthma Symptoms in Children

June 8, 2008 - At the European Academy of Allergology and Clinical Immunology (EAACI 2008) in Barcelona, ALK-Abelló presented successful results from a new clinical trial, GT-12, designed to measure the impact of GRAZAX® on allergic rhinitis and allergic asthma. GT-12 compared the effects of GRAZAX® with symptomatic medication versus symptomatic medication alone on the ability to reduce symptoms of allergic rhinitis and seasonal asthma.

A significant reduction of asthma symptoms was demonstrated. GRAZAX® reduced a combined asthma symptom score by 64%. The asthma symptoms included were: coughing, wheezing, chest tightening/shortness of breath (dyspnoea) and exercise induced symptoms. Participants in the study also experienced a 67% reduction in the number of days with asthma symptoms (median)... ALK-Abelló's Press Release -

Anesiva and Transcription Factor Therapeutics : Licensing Agreement for Development and Commercialization of NF-kappa B Clinical Program

June 5, 2008 - Anesiva, Inc. (Nasdaq: ANSV) announced that it has out-licensed all worldwide rights to its NF-kappa B Decoy (NF-kB Decoy) program, which includes the clinical drug candidate Avrina(TM), to Transcription Factor Therapeutics, Inc. (TFT). NF-kB Transcription Factor Decoy inhibits NF-kappa B, a protein implicated in the inflammatory cascade in diseases such as inflammatory bowel disease (IBD), eczema, rheumatoid arthritis, and asthma... Anesiva's Press Release -

AstraZeneca submits an sNDA for SYMBICORT® for the treatment of asthma in children as young as age six

June 4, 2008 – AstraZeneca (NYSE: AZN) announced that it submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for approval of a new indication for SYMBICORT® (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol for the long-term maintenance treatment of asthma in pediatric patients ages 6 to 11 years old. SYMBICORT is currently approved for the long-term maintenance treatment of asthma in patients 12 years and older... AstraZeneca' Press Release -

Critical Therapeutics : Phase II Clinical Trial for Zileuton Injection

Jun 02, 2008 - Critical Therapeutics, Inc. (Nasdaq: CRTX) announced top-line results from its Phase II clinical trial of the injectable formulation of zileuton (zileuton injection), the Company's investigational compound for acute asthma in the emergency department (ED). The clinical trial was designed to explore the pulmonary function profile, safety, tolerability and pharmacokinetic profile of zileuton injection.
Asthma results in approximately two million ED visits and 500,000 hospitalizations each year in the U.S., according to the Allergy and Asthma Foundation of America. It is estimated that ED visits and hospitalizations for asthma account for more than 50 percent of the healthcare costs of the disease... Critical Therapeutics' Press Release -

Novavax : Proprietary Method to Create SARS Vaccine and Renewal of NIH Funding for SARS Vaccine Development

May 22, 2008 - Novavax, Inc. (Nasdaq: NVAX) announced that it has created a new proprietary process to develop a vaccine candidate against Severe Acute Respiratory Syndrome (SARS). The company also received renewed research funding from the National Institutes of Health (NIH) to continue preclinical development of SARS vaccine candidates using Novavax's virus-like particle (VLP) technology... [PDF] Novavax's Press Release -

Jennerex Promising Results from Cancer Clinical Trial of JX-594 Published in Lancet Oncology

May 21, 2008 – Jennerex, Inc. (San Francisco, CA and Ottawa, Ontario), and its South Korean partner Green Cross Corp., announced today that Phase I clinical trial results from its first-in-class lead product JX-594 were published in the premier journal Lancet Oncology. The majority of these end-stage patients with solid tumors had objective tumor destruction and responses following treatment with the cancer biotherapeutic. Half of the JX-594-treated patients survived for more than eight months, well beyond their life expectancies of three to four months, and four patients with tumor responses survived for 11 to over 18 months. Results were especially promising for liver and lung cancer patients. Importantly, treatment with JX-594 was shown to be well-tolerated. A Phase II clinical trial is now underway for JX-594 in liver cancer. The world-wide liver cancer market is estimated at over one billion dollars per year... Jennerex's Press Release -

Emphasys Medical : VENT Clinical Trial Data at ATS 2008

May 12, 2008 - Emphasys Medical Inc., announced that one-year data from the VENT clinical trial of the company's Zephyr(R) Endobronchial Valve (EBV) will be presented at the International Conference of the American Thoracic Society (ATS) occurring May 16 to 21 in Toronto, Canada....
... The Zephyr EBV is a novel, minimally-invasive device intended to treat emphysema. The Zephyr EBV is designed to isolate diseased, overinflated portions of the lung and cause them to shrink thereby allowing healthier portions of the lung to function more normally... Emphasys Medical's Press Release -

Angiotech : completion of Bio-Seal clinical trial enrolment

June 3, 2008 - Angiotech Pharmaceuticals,Inc. (NASDAQ: ANPI, TSX: ANP), a global specialty pharmaceutical and medical device company, announced the completion of U.S. clinical trial enrolment for its novel Bio-Seal lung biopsy track plug...
...Bio-Seal is a novel technology designed to reduce the incidence of post-operative pneumothorax (collapsed lung) in patients who undergo lung biopsy procedures. The technology involves the placement of an expanding hydrogel plug along the biopsy needle track during the procedure, closing off the track to subsequent influx of air into the chest during respiration after the biopsy needle is withdrawn. The seal is airtight and the plug is absorbed into the body after healing of the puncture site has occurred... [PDF] Angiotech's Press Release -

Bayer HealthCare and Nektar Therapeutics : Amikacin Inhale Shows Promising Results in Phase II Study

May 19, 2008 , 2008 - Bayer HealthCare together with Nektar Therapeutics (Nasdaq: NKTR), today presented positive preliminary Phase II data on their unique drug-device combination Amikacin Inhale at the American Thoracic Society (ATS) annual meeting. Amikacin Inhale, currently being studied for the adjunctive treatment of Gram-negative pneumonia in intubated and mechanically-ventilated patients, achieved over 1000 times greater lung exposure to the antibiotic amikacin as compared to intravenous route of administration.
This shows that targeting antibiotic therapy to the site of infection might offer superior bacterial eradication and increased efficacy, which may result in a higher likelihood of the patient's survival. Currently, Gram-negative pneumonia carries a mortality risk as high as 50 percent in mechanically-ventilated patients(1)... Nektar Therapeutics' Press Release -

Lilly : Study Showed ALIMTA (pemetrexed for injection) Improved Survival in Certain Types of Non-Small Cell Lung Cancer

May 28, 2008 - The type of non-small cell lung cancer (NSCLC) patients have may now influence their treatment regimen and, in turn, survival outcome according to the results of a major study published online in the Journal of Clinical Oncology. Publication of the study was announced by Eli Lilly and Company.
The 1,725-patient study, the largest Phase III clinical trial in the first-line NSCLC setting, evaluated ALIMTA(R) (pemetrexed for injection) plus cisplatin versus GEMZAR(R) (gemcitabine HCl for injection) plus cisplatin, a standard of treatment in this setting. The trial met its primary endpoint of non-inferiority relative to overall survival... Lilly's Press Release -

GlaxoSmithKline : New data for pazopanib – GSK’s latest investigational anti-cancer agent – shows promise across multiple cancers

31 May 2008 - GlaxoSmithKline announced the results of two Phase II trials demonstrating the potential for pazopanib, an oral, investigational angiogenesis inhibitor, as a treatment for non-small cell lung cancer (NSCLC), [1] the most common form of lung cancer, [2] and renal cell carcinoma (RCC). [3] The data were presented at the 44^th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago. Pazopanib is not approved in any market for any indication at this time.

Pazopanib targets vascular endothelial growth factor receptor (VEGFR), platelet derived growth factor receptor (PDGFR) and c-kit, key proteins that help with the growth of new blood vessels in the body. [4] This process, known as angiogenesis, plays a critical role in the growth and spread of tumors. [5]... GlaxoSmithKline's Press Release -

Rosetta Genomics and M. D. Anderson to Develop a MicroRNA-based Diagnostic Test to Identify Risk of Recurrence of Lung Cancer

June 6, 2008 - Rosetta Genomics, Ltd. (NASDQ: ROSG), a leader in the development of microRNA-based diagnostic and therapeutic products, announced today a research collaboration with The University of Texas M. D. Anderson Cancer Center and the Kleberg Center for Molecular Markers to develop a microRNA- based diagnostic test to predict risk of disease recurrence in lung cancer patients who have undergone curative resection.

Current treatment for lung cancer includes surgical resection which may be followed by adjuvant therapy. While patients with high risk of recurrence may benefit from adjuvant therapy, those with low risk of recurrence may be exposed to unnecessary toxicities. The goal of this collaboration is to develop a test that will enable physicians to distinguish between patients with high and low risk of recurrence to optimize treatment regimens... Rosetta Genomics' Press Release -

GlaxoSmithKline : New data on MAGE-A3 cancer immuno therapy support novel options of treating non-small cell lung cancer and melanoma

30 May 2008 - New data presented by GlaxoSmithKline (GSK) highlighted the potential of its investigational MAGE-A3 Antigen-Specific Cancer Immunotherapeutic (ASCI) through results of three studies evaluating highly targeted immunotherapy as a treatment for metastatic melanoma and non-small cell lung cancer (NSCLC). These data were presented at the 2008 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago[Abstract Nos: 9065^[i], 9045^[ii] and 7501^[iii].

A randomised, open label Phase II study designed to evaluate two different formulations of the MAGE-A3 ASCI in patients with metastatic melanoma has been conducted. In this study, the ASCI, which is a combination of MAGE-A3 recombinant protein and a GSK proprietary Adjuvant System, was evaluated and resultant data suggest a positive trend for clinical response... GlaxoSmithKline's Press Release -

Pulmo BioTech : Details of the Methodology for its Phase I Human Trials

May 16 2008 - Pulmo BioTech Inc has announced details of the methodology and purpose of its Phase I Human Trials with its PulmoBind Molecular Imaging technology for the diagnosis of Pulmonary Embolism and Pulmonary Hypertension.

The work will be carried out by Pulmo BioTech subsidiary PulmoScience Inc and the title of the work is: “Phase I Study of the Use of PulmoBind for Molecular Imaging of the Pulmonary Circulation”.

The study will be a single center, Phase 1 safety and efficacy study of a single intravenous injection of PulmoBind in human subjects with no history of lung disease... Pulmo BioTech's Press Release -

MDS Pharma Services : Therapeutic Focus on Respiratory

May 20, 2008 - MDS Pharma Services, a leading provider of innovative drug discovery and development solutions, has named two experienced medical professionals to lead its late stage clinical trial management activities related to respiratory ailments and metabolic disorders. Dr. Bernard Tisserand and Dr. Jonny L. Salyer have been named Executive Medical Directors for Respiratory Disorders and Metabolic Disorders, respectively. These therapeutic areas represent serious global public health concerns and are key areas of focus for MDS Pharma Services' customers.

Respiratory disorders include conditions such as asthma, allergic rhinitis, chronic obstructive pulmonary disease (COPD), and community acquired pneumonia (CAP), while metabolic disorders include diabetes, dyslipidemia, obesity and metabolic syndrome, which is defined as a cluster of conditions that damage the cardiovascular system... MDS Pharma Services' Press Release -

DEY : Concomitant Use of Nebulized Formoterol Fumarate and Tiotropium Provides Significant Improvement in Dyspnea, COPD Symptoms and ...

May 20, 2008 – Data presented at the International Conference of the American Thoracic Society (ATS) demonstrate that concomitant therapy with Perforomist™ Inhalation Solution (formoterol fumarate inhalation solution; FFIS), delivered by nebulization, and Spiriva^® (tiotropium; TIO) is significantly more effective than treatment with tiotropium alone.
Perforomist Inhalation Solution was approved in 2008 by the FDA for long-term, twice-daily maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. It is the only FDA-approved nebulized formoterol fumarate... Dey's Press Release -

Almirall & Forest : Positive Results of Clinical Studies for Aclidinium Bromide, a Novel, Long-Acting Anticholinergic for the Treatment for COPD

May 20, 2008 - Forest Laboratories, Inc. and Laboratorios Almirall, S.A. presented results from four clinical trials assessing the efficacy and safety of aclidinium bromide, an investigational treatment for chronic obstructive pulmonary disease (COPD). Data from four preclinical studies further describing the properties of aclidinium were also presented at the meeting.

Presentations included data from a 464-patient randomized, double-blind, four-week, Phase IIb study that evaluated both the efficacy and tolerability of once-daily aclidinium (25 mcg, 50 mcg, 100 mcg, 200 mcg or 400 mcg) or placebo in patients with moderate to severe COPD. An open-label tiotropium (18 mcg) arm was included as an active control... Forest Laboratories' Press Release - Almirall's Press Release -

Basilea Pharmaceutica : Ceftobiprole shows high cure rates in patients hospitalized with community-acquired pneumonia

May 20, 2008 - Basilea Pharmaceutica Ltd. (SWX: BSLN) highlights the presentation of positive phase III results on ceftobiprole in the treatment of community-acquired pneumonia (CAP) requiring hospitalization at the International Conference of the American Thoracic Society (ATS). The detailed analysis of previously announced top line results demonstrate high cure rates in patients at risk for poor outcomes.

The randomized, double-blind phase III study compared clinical outcomes following the treatment with ceftobiprole versus ceftriaxone with or without linezolid in patients hospitalized with community-acquired pneumonia. The clinical cure rate in the clinically evaluable patient population with moderate to severe pneumonia was 87% for ceftobiprole and 88% for the comparator arm. In patients infected with Streptococcus pneumoniae, the most common pathogen in CAP, high cure rates were achieved with ceftobiprole (93%) and the comparator (89%). In the overall study population ceftobiprole met non-inferiority with a margin (delta) of 10%... Basilea Pharmaceutica's Press Release -

Perceptronix Medical : Early Detection Brings Hope

May 16, 2008 - "Early detection of any cancer is always the best hope for successful treatment and a positive outcome, but early detection for lung cancer has never been more important than now," says Bojana Turic, MD, president and CEO of Perceptonix Medical Inc., Vancouver, "when on average 388 Canadians will die of lung cancer every week."

Current international studies show that even smokers who have kicked the habit are still at risk of developing lung cancer since researchers believe that the lung tissue damaged by smoking may never repair to normal status and, therefore, former smokers continue to be at risk throughout their lifetime. The risk decreases the longer one has stopped smoking... [PDF] Perceptonix Medical's Press Release -

TeraRecon iNtuition : at the Stanford MDCT face-off in Las Vegas

May 15 , 2008 - TeraRecon, Inc., a leader in advanced imaging processing technology and 3D visualization solutions, applied new innovations in client-server advanced visualization at the 6th “Workstation Face-off” held at the 10th Annual Stanford University International Symposium on Multidetector-Row CT, held at the Wynn resort in Las Vegas.

The workstation face-off posed challenges at a new level of complexity and functionality to the participants, with clinical 4 cases to be reviewed in a total of less than 20 minutes. The assigned tasks included CT Colon, CT brain perfusion, quantitative vascular analysis of significantly diseased vessels in the head and neck, simultaneous CT-PET fusion of two pairs of data (one prior pair and one follow-up pair), detection and temporal change analysis of lung nodules from a prior / follow-up pair of CT lung scans, coronary CTA analysis of real-world, sub-optimal data, and processing of a surprise case presented “cold” during the face-off, to be loaded and processed on the spot, within the allotted time... TeraRecon's Press Release -

Critical Outcome Technologies : Amalgamation With DDP Therapeutics

May 2, 2008 - Critical Outcome Technologies Inc. (TSX VENTURE:COT) announced that it has amalgamated with its wholly owned subsidiary, 6441513 Canada Inc, operating as DDP Therapeutics (DDP) effective May 1, 2008. DDP was acquired as announced on November 27, 2007. This amalgamation completes the process of integrating the small cell lung cancer (SCLC) molecule library of DDP with the research development operations of Critical Outcome Technologies Inc. (COTI)... [PDF] Critical Outcome Technologies' Press Release -

Dako : unique package of RTU antibodies for cancer diagnostics

Apr 24, 2008 - Dako’s new set of ready-to-use antibodies, Flex RTU, is the largest and most clinically relevant antibody portfolio on the market. It has been developed for diagnosis of the most common types of cancer (breast, colon, lung, prostate, melanoma, etc.).

With the number of patients waiting for cancer diagnosis continually on the rise, Dako works to provide pathology laboratories with workflow solutions linking knowledge, reagents, instruments and software for fast and accurate answers... Dako’s Press Release -

Med BioGene and University Health Network : Collaboration to Commercialize Critical Lung Cancer Prognostic Test

April 23, 2008 - Med BioGene Inc. (TSX Venture: MBI) and the University Health Network (UHN) announced that they have entered into license and collaboration agreements providing MBI with exclusive, world-wide rights to develop and commercialize a critical prognostic test for early stage non-small-cell lung cancer developed by UHN. The test will be marketed under MBI’s trade name LungExpress Dx™.

LungExpress Dx™ is a gene expression-based assay that provides valuable information regarding each patient’s prognosis for survival to more effectively guide treatment and improve the selection of patients for chemotherapy following surgical removal of their cancerous tumour... Med BioGene's Press Release -