Vision-Sciences : Advanced, Video-Based Bronchoscope and EndoSheath® Technology to Enthusiastic International Pulmonary Market

BERLIN- Vision-Sciences, Inc. (Nasdaq: VSCI) announced the international introduction of its new, advanced video bronchoscopy platform at the 18th Annual European Respiratory Society (ERS) conference in Berlin, Germany. Over 17,000 participants attended the scientific and educational conference, the largest in Europe and one of the most comprehensive ever in the field of lung health and disease.

Vision-Sciences’ new bronchoscopy system is the latest addition to its revolutionary 5000 Series video endoscopy line. The new bronchoscope provides high resolution video imaging and superior endoscopic functionality. It employs the company’s proprietary EndoSheath^® technology, for the first time allowing pulmonologists high performance bronchoscopy combined with the unparalleled practice efficiency and enhanced safety of the EndoSheath^® technology... Vision-Sciences' Press Release -

Varian Medical Systems : Clinicians in Netherlands Treat Lung Cancer Patients Using New RapidArc Radiotherapy Technology

Oct. 14, 2008 - Doctors in the Netherlands have used RapidArc technology from Varian Medical Systems (NYSE: VAR) to treat four early stage lung cancer patients in what is believed to be among the world's first treatments of their kind. Clinicians at VU University Medical Center in Amsterdam now plan to replace conventional stereotactic radiotherapy treatments with RapidArc for all such patients.

A 57-year-old male, diagnosed with a 1.2cm diameter non-small cell lung tumor in the right upper lobe and deemed unfit for surgery as a result of severe emphysema, was the first patient to receive the pioneering radiotherapy treatment at the hospital in early September... Varian Medical Systems' Press Release -

Quark : Publication of Study on Use of siRNA against Proprietary Target for Inhibiting Tumor Growth and Sensitization of Cancer Cells to Chemotherapy

October 13, 2008 - Quark Pharmaceuticals, Inc., a development-stage pharmaceutical company discovering and developing novel RNA interference (RNAi)-based therapeutics, announced that the journal Cancer Research published results on efficacy of siRNA targeting its proprietary target gene against non-small cell lung cancer (NSCLC) in the edition dated October 1, 2008. The paper, entitled “RNAi-Mediated Silencing of Nuclear Factor Erythroid-2–Related Factor 2 Gene Expression in Non–Small Cell Lung Cancer Inhibits Tumor Growth and Increases Efficacy of Chemotherapy,” reports on research performed in collaboration with Professor Shyam Biswal of the Division of Pulmonary and Critical Care Medicine, School of Medicine, Johns Hopkins University. The results provide a basis for a potential new drug candidate to be added to Quark’s pipeline.
The study examined efficacy of RNAi-mediated reduction of Nuclear Factor Erythroid-2–Related Factor 2 (Nrf2) expression in vitro and in in vivo mouse NSCLC xenograft models alone or in combination with chemotherapy. The results show that RNAi-mediated reduction of Nrf2 expression generates reactive oxygen species, suppresses tumor growth, and increases sensitivity to chemotherapeutic drug–induced cell death... Quark Pharmaceuticals' Press Release -

Aerovance : Aerovant Inhalation Powder is Well Tolerated in Asthma Patients

Oct. 7, 2008 – Aerovance Inc. reported pharmacokinetic (PK) and safety data from a Phase I trial of its Aerovant inhalation powder that demonstrate good tolerability with no evidence of local irritancy following asthma patients’ inhalation of a single 10 mg dose.

This 10 mg dose will be the highest of three doses investigated in Aerovance’s Phase IIb dose-ranging study, which is scheduled to begin early next year. Evidence gathered from nonclinical and clinical studies indicates the primary action of Aerovant is local to the lung, while the PK data confirm that the dry powder inhaler achieved the targeted lung dose. The data were presented by E. Burmeister Getz, Ph.D, at the European Respiratory Society (ERS) Annual Congress in Berlin... Aerovance's Press Release -

Aires Pharmaceuticals : Key Technology License Agreement with the National Institutes of Health

October 21, 2008 - Aires Pharmaceuticals Inc., a drug development company focused on developing therapies for pulmonary conditions, announced the signing of an exclusive license agreement with the U.S. National Institutes of Health for the patented use of a nitric oxide prodrug to treat cardiopulmonary conditions.

The technology, identified at the NIH’s National Heart, Blood and Lung Institute, shows that nitrite, which is converted by the body into nitric oxide, can be delivered as an effective treatment for pulmonary hypertension, myocardial infarction, transplantation and cerebral vasospasm. Aires Pharmaceuticals is developing Aironite™, a proprietary, inhalable formulation of nitrite, to treat pulmonary arterial hypertension (PAH). The company has Orphan Drug Status from the U.S. Food and Drug Administration and has completed its first Phase I clinical trial for this indication... Aires Pharmaceuticals' Press Release -

Novartis and Nektar Therapeutics Pulmonary Business

Novartis' Press Release :
Novartis to acquire Nektar Therapeutics pulmonary business unit, strengthening respiratory drug delivery capabilities
October 21, 2008 - Novartis has strengthened its capabilities for developing medicines that can be delivered via the lungs through a definitive agreement to acquire the pulmonary drug delivery business unit of Nektar Therapeutics (NASDAQ: NKTR) for USD 115 million in cash.

Important capabilities gained from Nektar, which has approximately 140 associates who will join Novartis and remain in San Carlos, California, include product formulation and delivery expertise along with a broad device platform. This transaction excludes Nektar's inhalation programs for insulin, vancomycin, ciprofloxacin and amikacin.

Novartis will utilize these skills to build on existing capabilities and accelerate its pipeline targeting life-threatening diseases such as chronic obstructive pulmonary disease (COPD), asthma and cystic fibrosis as well as the life-cycle management of late-stage development projects that are closer to regulatory submissions. Potential applications will also be assessed in other areas of the Novartis healthcare portfolio... Novartis' Press Release -


Nektar's Press Release :
Nektar Sells Pulmonary Business to Novartis For $115 Million and Nektar Retains Key Pulmonary Programs Including Amikacin Inhale, Inhaled Vancomycin, and Ciprofloxacin Inhalation Powder
Oct 21, 2008 - Nektar Therapeutics (Nasdaq: NKTR) announced that Novartis AG has agreed to acquire from Nektar specific pulmonary delivery assets, technology, and intellectual property for $115 million in cash.

"This agreement will allow us to focus our efforts on the development of novel therapeutics using our PEGylation and conjugate chemistry-based drug development platforms," said Nektar President and CEO Howard W. Robin. "The transaction also strengthens our balance sheet and significantly reduces expenses. It is a perfect example of our ability to monetize assets that had little future value for Nektar."

Novartis will assume ownership of certain dry powder and liquid pulmonary formulation and manufacturing assets, including capital equipment and manufacturing facility capital lease obligations. The agreement also transfers to Novartis approximately
140 Nektar personnel, as well as certain intellectual property and manufacturing methods. Additionally, Nektar will transfer manufacturing and royalty rights to the Tobramycin inhalation powder (TIP) program, already partnered with Novartis... Nektar's Press Release -

Ranbaxy & GSK : IND APPLICATION TO DCGI FOR RESPIRATORY INFLAMMATION CANDIDATE

October 13 , 2008 - Ranbaxy Laboratories Limited (Ranbaxy) announced that the Company has submitted an Investigational New Drug (IND) application to the Drug Controller General of India for permission to initiate Phase-I human clinical trials. The IND application is for the Respiratory Inflammation candidate that the Joint GSK-Ranbaxy steering committee had identified earlier last year.

Ranbaxy has successfully completed all the required regulatory safety and toxicity studies on the drug candidate and also plans to seek regulatory approval in other countries outside India in order to initiate Phase-I human clinical trials at the earliest... Ranbaxy Laboratories' Press Release -

Bayer Schering Pharma : Progress in Clinical Program for Riociguat

October 6, 2008 – Based on positive Phase II trial findings, Bayer Schering Pharma will move into Phase III trials with its oral agent riociguat (BAY 63-2521). Riociguat is the first member of a new class of vasodilating agents called soluble guanylate cyclase (sGC) stimulators. It is being investigated as a new approach for the treatment of different forms of pulmonary hypertension. Riociguat demonstrated significantly improved exercise capacity in a Phase II study in patients with chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary arterial hypertension (PAH) as compared to baseline values. The Phase III program for these indications is planned to be initiated in late 2008... Bayer Schering Pharma's Press Release -

APT Pharmaceuticals : Phase III Trial of Inhaled Cyclosporine following Lung Transplantation

SEPTEMBER 30, 2008 - Proceeds to Fund Completion of Phase III Trial of Inhaled Cyclosporine following Lung Transplantation - APT Pharmaceuticals, a specialty drug development company focused on inhaled treatments for serious lung diseases, announced the completion of a $32.3 million Series B financing. The financing was led by Three Arch Partners and joined by additional new investors, InterWest Partners and Pinnacle Ventures. Existing investors Charter Life Sciences, Great Point Partners, Versant Ventures and Vivo Ventures also participated in the round... APT Pharmaceuticals' Press Release -

NeoGenomics Laboratories Extends Its Cancer Testing Services Through Exclusive Agreement with Response Genetics, Inc.

September 29, 2008 – NeoGenomics Laboratories (OTCBB: NGNM), a national clinical reference laboratory specializing in high-complexity, cancer-specific testing, announced an exclusive agreement with



Response Genetics Inc. (Nasdaq: RGDX) to offer its proprietary ResponseDX: Colon™ and ResponseDX: Lung™ tests nationwide. ResponseDX: Colon™ and ResponseDX: Lung™ are proprietary PCR-based tests in a cost-effective panel format which serve to help oncologists make optimal therapeutic treatment decisions for patients with colorectal cancer (CRC) and non-small cell lung cancer (NSCLC)... [PDF] NeoGenomics Laboratories' Press Release -

BioView : Interim Results of Early Detection Lung Cancer Diagnostic Test

September 24, 2008 – BioView Ltd, (TASE: BIOV ) from Rehovot, Israel, reported results of its internal clinical trial of the non-invasive diagnostic test under development for early detection of lung cancer.

In the trial a total of 76 sputum samples were collected from four groups of patients:
1. Healthy inviduals that never smoked
2. Heavy smokers with no signs of lung cancer
3. Early stage lung cancer patients (Stage 1)
4. Advanced stage lung cancer patients

The sputum samples were blindly scanned and analyzed morphologically and genetically, with fluorescent probes exclusively licensed to BioView, on BioView’s automated Duet scanning station by Company personnel. The results of the test were classified as “Normal”, i.e. no cancer detected and “Abnormal”, i.e. Cancer detected. These results were then compared to the actual data received from the hospital of the patients’ condition.

The samples included 32 cases of lung cancer patients (about half of them early stage patients) and 44 samples taken from people with no clinical evidence of lung cancer. Thirty one of the thirty two (96.9%) sick patients were correctly diagnosed as “Abnormal” and thirty six of forty four (about 82%) healthy people were correctly diagnosed as “Normal”... BioView's Press Release -

Novartis : Early data show potential for imatinib to treat life-threatening form of pulmonary artery disease

October 8, 2008 - An early proof-of-concept study presented shows promising results for imatinib in the treatment of pulmonary arterial hypertension (PAH), a severe, incurable blood vessel disorder.

Preliminary findings from a 59-patient, multi-center Phase II clinical trial suggest imatinib provides a treatment benefit, as demonstrated by a significant improvement in pulmonary vascular resistance and a numerical increase in cardiac output, key hemodynamic measures used to monitor the progression of the disease. Improvements in the six-minute walk test, the primary endpoint of the study, approached, but did not reach, statistical significance... Novartis' Press Release -

Alfacell's ONCONASE(R) Targets siRNA : Paper in Cell Cycle

Oct. 9, 2008- Alfacell Corporation (Nasdaq: ACEL) announced that a paper published in Cell Cycle (2008; Vol. 7, Issue 20) reports that ONCONASE (ranpirnase) targets small interfering RNA (siRNA), likely within the RNA-induced silencing complex (RISC) of the RNA interference (RNAi) mechanism.

The paper is the result of research conducted by collaborators at the Brander Cancer Research Institute and Department of Pathology at New York Medical College and Alfacell. The study demonstrated that silencing the glyceraldehyde 3-phosphate dehydrogenase (GAPDH) gene (an abundant and ubiquitously expressed housekeeping gene) in human lung adenocarcinoma A549 cells by siRNA was effectively prevented by ONCONASE. While transfection of cells with GAPDH siRNA reduced expression of this protein by nearly 70 percent, the expression was restored in the cells exposed to ONCONASE for 48 or 72 hours. The data thus provide evidence that one of the targets of ONCONASE (ranpirnase) is siRNA... Alfacell's Press Release -

Neotropix : Expansion of On-going Clinical Trial for Adult Neuroendocrine Cancers

October 8, 2008 - Neotropix®, Inc., a clinical-stage development company focused on neuroendocrine cancer treatments, announced that it has begun enrolling neuroendocrine cancer patients into an expanded clinical trial of its lead candidate, NTX-010 (SVV-001), a tumor-selective naturally-occurring oncolytic virus. Neotropix® also announced that it has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) of NTX-010 for the treatment of neuroendocrine tumors.

After reviewing safety data from the current Phase I dose escalation study, conducted in neuroendocrine cancer patients, and as previously defined in the on-going protocol, the study is open to recruit more patients at the highest dose planned for long-term drug development. The expansion phase of the study allows the clinical sites to enroll additional patients meeting the enrollment criteria to evaluate safety and efficacy across a range of related cancers. To date, the Company has tested this clinical candidate, primarily in patients with carcinoid cancers of multiple origins, small cell cancer, including lung cancer, pancreatic islet cancer, and neuroendocrine cancers of unknown origin... Neotropix' Press Release -

Health Hero Network : Recertification from National Committee for Quality Assurance (NCQA) for Chronic Care Programs

October 23, 2008 - Health Hero Network, a leading innovator of technology solutions for chronic care management, announced today that it has received recertification in Disease Management from the National Committee for Quality Assurance (NCQA) for 10 of its Health Buddy® health management programs. NCQA certification indicates that Health Buddy® Programs have passed rigorous reviews for their quality in implementing evidence-based practice guidelines for patient education and care management. These programs are delivered via the Health Buddy System, which serves as the interface between patients at home and care providers, facilitating patient education and monitoring of chronic conditions. “We appreciate NCQA’s continued recognition and validation that our Health Management programs meet the highest level of quality,” says Leslie Honor, RN, Clinical Director for Health Hero Network. “This recertification assures our customers that these Health Buddy Programs indeed offer quality care management for their patients with chronic illnesses.”

Health Buddy® System

NCQA DM certification standards are intended to help organizations achieve the highest level of performance possible, reduce patient risk, and create an environment of continuous improvement. Health Hero Network received recertification in all ten previously recognized areas of care. The Health Buddy Programs recertified by NCQA include asthma, cancer, cardiovascular disease, chronic pain, depression, pediatric asthma, chronic heart failure (CHF), chronic obstructive pulmonary disease (COPD), diabetes, and hypertension programs... Health Hero Network's Press Release -

Teva Pharmaceutical : Proair® HFA, the Market Leading Albuterol Inhaler, Receives New Pediatric Indication

September 24, 2008 - Teva Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved ProAir® HFA (albuterol sulfate) Inhalation Aerosol for use in patients as young as 4 years of age. Previously, ProAir HFA had been indicated for use in patients aged 12 and older.
In clinical studies, ProAir HFA, the market leading albuterol sulfate inhaler, exhibited significant bronchodilator efficacy in pediatric asthmatics aged 4 to 11 years. ProAir HFA provides physicians with a treatment option to help relieve children's asthma symptoms as they occur wherever they occur, which is especially important as children return to school. With asthma affecting more than one child in every 20 in the United States, studies show that asthma emergency room and hospitalization rates spike in September... Teva Pharmaceutical's Press Release -

Gemin X : Key U.S. Patent Issued for Obatoclax

September 23, 2008 -Novel Pan Bcl-2 Inhibitor is a Potential Treatment for Broad Range of Cancers - Gemin X, a clinical stage biopharmaceutical company developing novel, targeted cancer therapeutics, announced that the United States Patent & Trademark Office issued to Gemin X a patent protecting the composition of matter of obatoclax through 2025 - U.S. Patent No. 7,425,553. One of Gemin X's lead pipeline programs, obatoclax is an oncology treatment based on programmed cell death, or apoptosis, and has the potential to be a first-in-class pan Bcl-2 inhibitor. Obatoclax is currently in Phase 2 clinical trials for the treatment of elderly acute myeloid leukemia and the treatment of small cell lung cancer... Gemin X's Press Release -

Kuros Biosurgery and Aeris Therapeutics : Exclusive License Agreement in the Field of Lung Volume Reduction

September 23, 2008 - Kuros Biosurgery AG and Aeris Therapeutics, Inc., both privately held biotech companies, announced today that Kuros has granted Aeris an exclusive license in the field of lung volume reduction to certain patent rights Kuros exclusively licensed from the American Red Cross that cover the delivery of certain drugs in a fibrin sealant. In return for the license, Kuros will receive upfronts, milestones and royalties on the sale of Aeris’ lead product, the AeriSeal™ Biologic Lung Volume Reduction (BLVR) System, a novel investigational emphysema treatment. Aeris is currently preparing for the initiation of Phase 3 clinical trials for the AeriSeal BLVR system... [PDF] Kuros Biosurgery's Press Release - Aeris Therapeutics' Press Release -

REGENERX : RGN-457 for Cystic Fibrosis

October 01, 2008 - REGENERX BIOPHARMACEUTICALS, INC. (AMEX:RGN) announced that it is seeking a strategic partner to assist in the development of RGN-457 for the treatment of cystic fibrosis (CF). RGN-457 is based on thymosin beta 4 (TB4) peptide formulated as an inhaled therapeutic agent to address this patient population. CF is a life-threatening, hereditary disease that impairs the patient's ability to breathe due to the accumulation of thick and sticky mucus secretions in the airways of the lungs. There are estimated to be 30,000 and 40,000 CF patients in the U.S. and Europe, respectively. It is, therefore, considered an "orphan" disease in both territories. In 2006, the predicted median age of survival for patients with cystic fibrosis was 37 years... REGENERX BIOPHARMACEUTICALS' Press Release -

Gilead Complete Response Letter from U.S. Food and Drug Administration for Aztreonam Lysine for Inhalation, an Investigational Treatment for CF

Sept. 16, 2008 - Gilead Sciences, Inc. (Nasdaq:GILD) announced that the company has received a complete response letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for aztreonam lysine for inhalation, an investigational therapy in development for people with cystic fibrosis who have Pseudomonas aeruginosa (P. aeruginosa).

In this letter, the FDA informed Gilead that the review of the company's NDA has been completed. The agency stated that they cannot approve the application in its current form and an additional clinical study will be required. Gilead will continue its dialogue with the FDA to determine whether further analyses of existing data could lead to approval, or whether the company will need to conduct the additional study as stated in the letter... Gilead Sciences' Press Release -

MD Biosciences : Preclinical Disease Models at the 15th International Inflammation Research Association Conference

September 15, 2008 – MD Biosciences, a global biotechnology company focused in inflammations & neurology research will showcase its inflammations related pre-clinical services and research products at the Inflammation Research Association (IRA) International Conference, September 21-24, Chantilly, VA. Capabilities featured will be pre-clinical efficacy disease models and research products for drug discovery and research.

MD Biosciences will be hosting a lunch and learn session titled “Discovery of novel therapies for asthma requires suitable and relevant disease models”. Conference attendees are invited to register for this free session upon arrival of the conference. This session will focus on the OVA-induced Asthma model and airway hyperresponsiveness (AHR) as well as the OVA-IgE specific ELISA for measuring OVA specific IgE levels in murine serum samples... MD Biosciences' Press Release -

Medical Acoustics : Results on Efficacy of Medical Acoustics’ Lung Flute® to be Presented at European Respiratory Society Congress

September 22, 2008 — Medical Acoustics LLC, a commercial-stage medical device company which employs acoustic technologies for diagnostic and therapeutic medical applications, announced that the tuberculosis (TB) study of its innovative and easy to use pulmonary device, the Lung Flute^®, conducted by Dr. Akira Fujita, and Dr. Kengo Murata at Tokyo Metropolitan Fuchu Hospital, Tokyo, Japan, has been accepted for a presentation at the European Respiratory Society’s Annual Congress on October 6^th 2008, in Berlin, Germany. The results of the study, entitled “A Novel Method for Sputum Induction by the Lung Flute^® in Patients Suspected of Pulmonary Tuberculosis” were previously presented at the APSR Congress in Australia in December 2007 and at the Japanese Respiratory Society Conference in Kyoto, Japan in June 2008... Medical Acoustics' Press Release -

Arriva Pharmaceuticals : Protein Production Patent

1 October 2008 - Arriva Pharmaceuticals, a biopharmaceutical company focused on developing anti-inflammatory therapies, announced that it had been granted a patent in the U.S. for methods to produce certain proteins in yeast. Among the proteins whose production is covered by the patent (United States Patent 7,419,801) is recombinant alpha 1-antitrypsin (rAAT), the protein used in Respriva™, the company’s lead product.

“This patent extends our patent portfolio and strengthens our intellectual property estate for Respriva™,” said Sue Preston, chief executive officer of Arriva. “As we move forward with the development of Respriva™, we have multiple competitive advantages that leave us well positioned in the global market.”

Respriva™ is an inhaled rAAT. Arriva is currently conducting clinical trials with Respriva™ as replacement therapy in hereditary emphysema (HE). Patients with HE have a congenital deficiency in naturally occurring alpha 1-antitrypsin (AAT). Respriva™ also has the potential to ameliorate lung disease in other indications, such as chronic obstructive pulmonary disease (COPD), asthma and cystic fibrosis... [PDF] Arriva Pharmaceuticals' Press Release -

Dynavax Technologies : Milestone from AstraZeneca

Sep 22, 2008 - Novel Asthma/COPD Drug Candidate Nominated for Clinical Development - Dynavax Technologies, Inc. (NASDAQ:DVAX) announced receipt of a $4.5 million milestone payment from its partner AstraZeneca AB for the nomination of candidate drug AZD1419 for the treatment of asthma and chronic obstructive pulmonary disease (COPD). As part of this potential $136 million development and commercialization collaboration, AstraZeneca and Dynavax have initiated Investigational New Drug (IND) enabling studies with AZD1419 and plan to begin phase 1 clinical development in 2009.


AZD1419 represents a new strategy for the treatment of allergic respiratory diseases such as asthma. AZD1419 is designed to modify the course of these diseases by reprogramming the immune response to multiple allergens. AZD1419 is based on Dynavax's proprietary second-generation immunostimulatory sequences (ISS), which are short DNA sequences that specifically target Toll-Like Receptor 9 (TLR9) to stimulate the innate immune response... Dynavax Technologies' Press Release -

Advanced Life Sciences : NDA Submission for Cethromycin in Community Acquired Pneumonia

Oct. 1, 2008 - Advanced Life Sciences Holdings, Inc. (Nasdaq: ADLS), announced the submission of a new drug application (NDA) for cethromycin in mild-to-moderate community acquired pneumonia (CAP). Advanced Life Sciences also entered into debt and equity financing agreements to strengthen its balance sheet and help fund commitments associated with the NDA submission and pre-commercialization activities.

CAP is the sixth most common cause of death in the United States. CAP and other respiratory tract infections are caused by pathogens such as Streptococcus pneumoniae and Haemophilus influenzae. CAP affects 5.6 million patients in the United States each year, with 10 million physician visits and 2 million hospitalizations occurring annually.

Macrolides and penicillins are currently the front-line treatments for respiratory tract infections such as CAP. As macrolide and penicillin resistance grows and has the potential to cause more clinical failures, there is a need for new antibiotics with unique mechanisms of action that can overcome this emerging resistance... Advanced Life Sciences' Press Release -

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 -