Masimo : Desaturation Index 3D Alarm as Standard Feature in All Radical-7 Pulse CO-Oximetry Devices

September 10, 2008 – Masimo (NASDAQ: MASI), the inventor of Pulse CO-Oximetry and Measure-Through-Motion-and-Low-Perfusion pulse oximetry, announced that all customers purchasing the Masimo Radical-7, the company's flagship product, will now receive Desat Index 3D Alarm as a standard feature.

Conventional pulse oximeters typically alarm based on large and isolated drops in oxygen saturation values, known as a "desaturation". However, published research has shown that a cycle of moderate desaturations has been shown to precede respiratory failure in hospitalized patients.^{1, 2} Masimo Desat Index 3D Alarm enables advanced notification of these conditions, based on clinician-specified severity and number of desaturations occurring in a specified period of time... Masimo's Press Release -

Pharmaxis : Second Pivotal Phase 3 Trial In Cystic Fibrosis

4 September 2008 - Pharmaceutical company Pharmaxis (ASX:PXS, NASDAQ:PXSL) announced that it has enrolled the first subject into its second pivotal Phase 3 clinical trial evaluating Bronchitol in cystic fibrosis sufferers.
The Phase 3 trial is being conducted in 41 hospitals across North America, Argentina and Germany, and is the final clinical step before Pharmaxis seeks approval to market Bronchitol for cystic fibrosis in the United States... [PDF] Pharmaxis' Press Release -

Simcere Pharmaceutical : Interim Results of Endu Phase IV Clinical Study

Sept. 3, 2008 - Simcere Pharmaceutical Group (NYSE: SCR), a leading manufacturer and supplier of branded generic pharmaceuticals and manufacturer of the patented anti-cancer biotech product Endu (also known as Endostar) in China, announced the interim results of Endu Phase IV clinical study.

At the request of the SFDA, Simcere initiated a Phase IV clinical study to further validate the safety and therapeutic efficacy of Endu, a modified version of recombinant human endostatin, in combination with platinum-based chemotherapy, on large samples of patients in advanced stages of non-small cell lung cancer (NSCLC). The primary endpoint of this study was to evaluate the safety and therapeutic efficacy of Endu in conjunction with platinum-based chemotherapy. It is designed as an open label, prospective, and multi-center Phase IV study, which for the interim results, included 648 patients at the advanced stages of NSCLC. This study is led by the center of Good Clinical Practice (GCP) of Cancer Hospital of Chinese Academy of Medical Sciences... Simcere Pharmaceutical's Press Release -

Oncolytics Biotech : U.S. Phase 2 Combination Clinical Trial for Non-Small Cell Lung Cancer Patients with K-RAS or EGFR-Activated Tumours

September 2, 2008 - Oncolytics Biotech Inc. (“Oncolytics”) (TSX:ONC, NASDAQ:ONCY) announced that following U.S. Food and Drug Administration (FDA) review, the Company is initiating a U.S. Phase 2 clinical trial using intravenous administration of REOLYSIN® in combination with paclitaxel and carboplatin in patients with non-small cell lung cancer (NSCLC) with K-RAS or EGFR-activated tumours. The Principal Investigator is Dr. Miguel Villalona-Calero, Professor Division of Hematology/Oncology and Department of Internal Medicine and Pharmacology at The Ohio State University Comprehensive Cancer Center... Oncolytics Biotech's Press Release -

Forest Laboratories and Almirall : Phase III Clinical Studies of Aclidinium Bromide Show Statistical Significance vs. Placebo in Patients With COPD

Sept. 3, 2008 - Forest Laboratories, Inc. (NYSE: FRX) and Laboratorios Almirall, S.A. announced results from two global Phase III studies of aclidinium bromide, a novel long-acting inhaled anticholinergic for the treatment of patients with chronic obstructive pulmonary disease (COPD).

In both the ACCLAIM/COPD I&II (AClidinium CLinical Trial Assessing Efficacy and Safety In Moderate to Severe COPD Patients) studies, once-daily aclidinium bromide showed a statistically significant difference vs. placebo in the primary endpoint trough FEV1, a measure of pulmonary function that is decreased in moderate to severe COPD patients... Forest Laboratories' Press Release -

Boehringer Ingelheim & Pfizer : Established Safety Profile of Spiriva Confirmed by 30 Rigorously Controlled Clinical Trials & the Landmark Trial UPLIF

23 September 2008 - Boehringer Ingelheim and Pfizer have released a new analysis of 30 rigorously controlled clinical trials confirming the long term safety profile of Spiriva^® (tiotropium). The new and expanded safety data contradicts the conclusions about tiotropium in an article by Singh et al. published in the 24 September issue of the Journal of the American Medical Association.¹ Both companies considered it important to release these data to ensure doctors have the most comprehensive, up-to-date safety information on tiotropium in order to make the best treatment decisions for their patients.



Because COPD patients (Chronic Obstructive Pulmonary Disease) have in general a higher cardiovascular risk than the average population,² cardiovascular safety in a COPD medication is of critical importance. Therefore Boehringer Ingelheim has put special emphasis on the broad investigation of Spiriva^® including its cardiovascular safety... Boehringer Ingelheim's Press Release - Pfizer's Press Release -

Wyeth Pharmaceuticals : Major Adult Vaccine Clinical Trial for Pneumonia Prevention

September 23, 2008 ― Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced the initiation of the Community Acquired Pneumonia Immunization Trial in Adults a major study in adults of an investigational 13-valent conjugate vaccine designed to help prevent pneumococcal pneumonia – the leading cause of bacterial pneumonia in adults.

In Europe and the United States, pneumococcal pneumonia is the most common community-acquired bacterial pneumonia, for which the adult mortality rate averages between 10 to 20 percent. That rate may exceed 50 percent in high-risk groups worldwide.

The results from this trial are not intended or required for inclusion in Wyeth’s currently planned regulatory filings for the use of the 13-valent pneumococcal conjugate candidate vaccine in adults. Rather, this study is being initiated proactively as part of a Phase 4 commitment, and in agreement with the U.S. Food and Drug Administration (FDA).

The Community Acquired Pneumonia Immunization Trial in Adults is a double-blind, placebo-controlled study expected to enroll approximately 85,000 participants 65 years of age and older. The study is being conducted by the Julius Center for Health Sciences and Primary Care at the University Medical Center Utrecht in the Netherlands. Participants in the trial will receive either Wyeth’s investigational 13-valent pneumococcal conjugate vaccine or placebo... Wyeth Pharmaceuticals' Press Release -

Cystic fibrosis : Axentis Pharma Initiates Clinical Trial for Lung Infections

05 Sep 2008 - Axentis Pharma AG has initiated a clinical phase IIa trial to assess the safety and tolerability of a new therapeutic formulation for the treatment of severe pulmonary infection in cystic fibrosis patients. The new formulation allows an established therapeutic agent to be delivered directly to the site of infection. The forthcoming trial will also compare the effects of two different doses of the new drug. Initial results are expected in summer 2009. Axentis Pharma acquired all the necessary rights for this formulation from international partners just eight months ago. In addition to these advances, the company has also succeeded in appointing two renowned experts to its Scientific Advisory Board.
Axentis Pharma AG (Switzerland) announced that all the necessary requirements for a clinical phase IIa trial have been fulfilled. The objective of this trial is to assess the safety and tolerability of an inhalable tobramycin, a well characterised and established drug for the treatment of pulmonary infection in cystic fibrosis patients. The product ARB-CF0223 also known as Fluidosome(R) tobramycin is a liposomal formulation of tobramycin, delivered directly to the site of infection via standard nebulizers. ARB-CF0223 has an improved safety profile and higher efficacy compared to current treatments for infections of the respiratory tract in patients with cystic fibrosis. It can be used in lower doses and also reduces the frequency and severity of side effects for pulmonary infections. The company expects to begin recruiting patients at its four international trial centres by the end of the year... [PDF] Axentis Pharma AG's Press Release-

MERCK SERONO SUBMITS NEW LICENSE APPLICATION FOR ERBITUX IN FIRST-LINE NON-SMALL CELL LUNG CANCER IN EUROPE

September 11, 2008 – Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced that it has submitted an application to the European Medicines Agency (EMEA) to license Erbitux® (cetuximab) for the first-line treatment of epidermal growth factor receptor (EGFR) expressing, advanced or metastatic non-small cell lung cancer (NSCLC).
The submission is supported by data from the Phase III FLEXa study presented this year at the plenary session of the American Society of Clinical Oncology (ASCO) Annual Meeting. The study demonstrated a significant increase in overall survival for patients receiving Erbitux in combination with a platinum-based chemotherapy as a first-line treatment for advanced NSCLC... [PDF] Merck Serono's Press Release -

Tianyin Pharmaceutical : Chinese SFDA Approval for Laonian Kechuan Tablets

Sept. 11, 2008 - Tianyin Pharmaceutical, Co., Inc., (OTC Bulletin Board: TYNP), a manufacturer and supplier of modernized traditional Chinese medicine ('TCM') based in Chengdu, China, announced that the Company has received approval from the Chinese State Food and Drug Administration (SFDA) to produce Laonian Kechuan Tablets in the dosage form of 0.25 gram/tablet (SFDA approval number Z20083360). The Company plans to launch Laonian Kechuan Tablets in the domestic market and begin recording revenue in November 2008.

Laonian Kechuan Tablets is a TCM drug that effectively treats asthma in people aged 60 or above. According to Chinese SFDA statistics, the market size in China for asthma drugs exceeded $580 million in 2004. Due to the low toxicity and high efficacy, TCM's for asthma have proven to be more readily accepted by patients, and currently comprise over 75% share of the retail market segment for long-term asthma drug users... Tianyin Pharmaceutical's Press Release -

Compugen : Peptide Drug Candidate for Treatment of Solid Tumor Cancers and Positive In Vivo Results

September 16, 2008 – Compugen Ltd. (NASDAQ: CGEN) announced that its proprietary DAC Blockers Discovery Platform has led to the discovery of CGEN-25008, a novel peptide antagonist of the Clusterin protein. Compugen also announced that recently analyzed in vitro and initial in vivo results from cell-based assays and a lung cancer mouse model indicate that CGEN-25008 reduces the growth rate of several cancer cell lines and significantly enhances the anti-cancer activity of Taxol™, a frequently used cancer chemotherapeutic drug.
Compugen’s DAC Blockers Platform was designed to predict peptides that can block proteins of interest from achieving certain disease-associated three-dimensional conformations. This discovery platform, announced in March 2008, is one of nine proprietary discovery platforms, to date, that have been developed and validated by Compugen for predictive discovery of drug and diagnostic product candidates... Compugen's Press Release -

Aeris Therapeutics : Phase 2 Trial Results for Non-Surgical Emphysema Treatment

September 3, 2008 - Biologic Lung Volume Reduction (BLVR) System Trial Achieves Primary Efficacy Endpoint; Preparations for Phase 3 Trials are Underway – Aeris Therapeutics, Inc., a company specializing in the development and commercialization of novel treatments for patients with emphysema and other advanced lung diseases, announced that the primary efficacy endpoint in Phase 2 clinical trials for its Biologic Lung Volume Reduction (BLVR) System has been achieved. BLVR is designed to provide a safe non-surgical alternative to lung volume reduction surgery, one of the few available treatments for patients with advanced emphysema. The BLVR system is the first biologic therapy that has been successfully used to remodel the lung and improve breathing function... Aeris Therapeutics' Press Release -

Draeger Medical Extends Its Partnership with Intensive Care On-Line Network, Inc. (ICON)

27.08.08 – Draeger Medical Inc. has announced its enhanced and exclusive partnership with Intensive Care On-Line Network (ICON) to provide 24x7 clinical and educational support for Dräger ventilation equipment now including the Babylog 8000+.

ICON has supported Draeger Evita Series ventilator customers in the United States and Canada beginning in September 2001 and has since extended support to Savina and Babylog ventilator customers.

ICON uses telephone and broadband technology to connect subscribers to its Critical Care Resource Center, which provides immediate live support for users of Draeger Evita, Savina and now, Babylog 8000+ ventilators. ICON clinicians are certified and trained in the use of these Draeger ventilators and are available 24x7 to answer questions about the equipment, assist in troubleshooting alarms and help guide ICU staff through critical ventilation issues. ICON clinicians can even be contacted via live video, enabling uni- or bidirectional visual and audio interaction between ICU staff and the support team... [PDF] Draeger Medical's Press Release -

Orexo : clinical phase II program for OX914 - a new product candidate for the treatment of inflammatory airway diseases

September 2, 2008 - Orexo AB (OMX: ORX), the Swedish pharmaceutical company, announced that the phase II program for the product OX914 has started. This is a new product candidate for the treatment of inflammatory airway diseases including asthma, COPD (chronic obstructive pulmonary disease) and rhinitis.

OX914 is a so called PDE4 inhibitor with an improved safety profile in development for the treatment of asthma, COPD and rhinitis.

The patients will be treated with OX914 in a disease model for inflammatory airway disease. Thirty six patients with seasonal allergic rhinitis will be given placebo or OX914 in doses of 15 or 50 mg for two weeks in a double blind 3-way cross-over study. Effects on nasal symptoms, inflammatory response, as well as safety and tolerability will be documented... Orexo's Press Release -

Discovery Labs : Aerosolized KL-4 Surfactant Selected for Evaluation in Phase 2a Cystic Fibrosis Clinical Trial

September 3, 2008 - First Clinical Trial Evaluating Aerosolized KL-4 Surfactant in Patients With Cystic Fibrosis - Discovery Laboratories, Inc. (NasdaqGM:DSCO) announces that its proprietary, aerosolized KL-4 surfactant has been selected for a Phase 2a clinical trial in patients with Cystic Fibrosis (CF). The trial is being conducted as an investigator-initiated study under the direction of Dr. Scott H. Donaldson at The University of North Carolina and is funded primarily through a grant provided by the Cystic Fibrosis Foundation.
The trial is designed as a double-blind, randomized study to evaluate whether Discovery Labs' aerosolized KL-4 surfactant is safe and well tolerated in patients with mild to moderate CF lung disease. In addition, the short-term effectiveness of aerosolized KL-4 will be assessed. UNC's Investigational New Drug (IND) Application for this study was submitted to the United States Food and Drug Administration and went into effect in May 2008. Patient enrollment is expected to begin this fall.

CF is characterized by a genetic mutation that produces thick, viscous mucus that is difficult to clear from the airways of the lung and typically leads to life-threatening respiratory infections. Preclinical and exploratory clinical studies suggest that therapeutic surfactants may improve lung function by loosening mucus and making it easier to clear... [PDF] Discovery Labs' Press Release -

Idera Pharmaceuticals : Milestone Payment Under Asthma and Allergy Collaboration

Sept. 2, 2008 - Idera Pharmaceuticals, Inc. (Nasdaq: IDRA), announced that it will receive a milestone payment from Novartis under the two companies' research collaboration and license agreements. Under the terms of the agreement, the payment was triggered by the initiation of a Phase 1 clinical study by Novartis of QAX935. QAX935 is a novel agonist of Toll-Like Receptor 9 (TLR9) exclusively licensed by Idera to Novartis...

...About the Collaboration

In June 2005, the Company and Novartis announced they had entered into research collaboration and license agreements for the discovery, optimization, development, and commercialization of TLR9 drug candidates targeting asthma and allergy based on Idera's proprietary Immune Modulatory Oligonucleotide (IMO(TM)) technology platform. The agreements are structured in two phases. During the research collaboration phase, the Company and Novartis have been working together to evaluate novel IMOs from which Novartis may select IMO candidates for further development through human clinical "proof of concept" trials. Based on the results, Novartis may then elect to implement the commercialization agreement, complete the development and commercialize one or more of the IMO candidates... Idera Pharmaceuticals' Press Release -

ImClone Systems : ERBITUX(R) Phase 3 BMS-099 Lung Cancer Study Secondary Endpoint Update: Overall Survival Results Announced

Aug. 29, 2008 - ImClone Systems Incorporated (NASDAQ: IMCL) announced overall survival results from BMS CA225-099 (BMS-099), an open-label Phase 3 study of ERBITUX(R) (cetuximab) in combination with a taxane and carboplatin in the first-line treatment of all histological subtypes of advanced non-small cell lung cancer (NSCLC).

These results pertaining to overall survival, a secondary endpoint, are an update to the previously reported results for progression-free survival (PFS), the study's primary endpoint, which were announced in June 2007. The study did not meet its primary endpoint of PFS, as assessed by an independent radiology review committee (IRRC). Response rate, as assessed by the IRRC, and PFS, as assessed by clinical investigators, were statistically significant and favored the ERBITUX-containing arm... ImClone Systems' Press Release -