Philips introduces HomeLox : only system that generates and stores liquid oxygen at home

June 21, 2011 - Philips introduces only system that generates and stores liquid oxygen at home; HomeLox helps increase freedom for patients and reduces costs for providers — Royal Philips Electronics (NYSE: PHG, AEX: PHI) introduced the HomeLox portable liquid oxygen system. The innovative system enables oxygen users to generate and store the liquid form of oxygen in the home setting. The HomeLox system offers users the long-lasting and lightweight characteristics of traditional liquid systems, while freeing them from difficulties of filling and dependence on deliveries associated with conventional systems.

Home oxygen is a critical, life-sustaining medical treatment prescribed to nearly 1.5 million Medicare patients annually who suffer from respiratory illnesses such as chronic obstructive pulmonary disease (COPD). (National Heart, Lung, and Blood Institute and American Thoracic Society)

HomeLox includes a liquid oxygen generation and storage unit that remains in the user’s home, and a lightweight and long-lasting portable device, GoLox. HomeLox generates liquid oxygen by converting room air into oxygen, and then chilling and converting it to liquid form using a proprietary refrigerant along with standard refrigeration technology found in industrial and household applications. The liquid oxygen is stored within the HomeLox unit until transferred to GoLox for portable use.



In addition to giving users the ability to generate and store liquid oxygen at home, the HomeLox system features a new hands-free clean filling process. To fill the GoLox portable device, the user simply places the unit on top of HomeLox, turns and locks the unit, and pulls the filling lever. The hands-free process helps reduce freezing, overfilling, and under filling.

For homecare providers, the new HomeLox liquid system reduces the cost and complexity of current systems commonly associated with delivered liquid oxygen systems which may include the purchase of specialized vehicles, testing equipment, and storage containers, as well as recurrent deliveries and filling-related service calls... Philips' Press Release -

Cephalon : Encouraging Results of Obatoclax in Extensive-Stage Small Cell Lung Cancer at ASCO Annual Meeting

June 7, 2011 – Cephalon presented new phase 2 data on an investigational compound, obatoclax, at the 47th Annual Meeting of the American Society of Clinical Oncology in Chicago, Ill. The data show that patients with extensive-stage small cell lung cancer receiving obatoclax in addition to standard chemotherapy demonstrated a trend toward improved overall response rate (ORR), progression-free survival (PFS) and overall survival (OS) when compared to chemotherapy alone. This is the first presentation of solid tumor data for the Company following its acquisition of Gemin X in March 2011, which developed the drug. Obatoclax expands the Cephalon portfolio in oncology beyond hematologic malignancies.
“Small cell lung cancer is a deadly and fast-growing tumor type. Approximately 65 percent of patients with this type of lung cancer have extensive disease at presentation and new approaches to treatment are needed,” said Lesley Russell, Chief Medical Officer at Cephalon. “The results of this study, suggest that obatoclax could be a new treatment option for patients if these treatment effects are replicated in a larger phase 3 study.”... Cephalon's Press Release -

Insmed : ARIKACE® Demonstrates Sustained Benefit Through Six Cycles of Treatment for Cystic Fibrosis Patients With Pseudomonas Lung Infections

June 10, 2011 - Insmed Incorporated (Nasdaq CM: INSM), a biopharmaceutical company, announced positive data through six treatment cycles (72 weeks total duration) of its Phase 2 clinical trial program for ARIKACE® (liposomal amikacin for inhalation) in cystic fibrosis (CF) patients with Pseudomonas lung infections. The data were presented at the 34th European Cystic Fibrosis Conference in Hamburg, Germany, by Predrag Minic, M.D., Professor of Pediatrics and Head of Pediatrics Pulmonology Department, Mother and Child Health Institute, Belgrade, Serbia, and co-lead investigator of the study.

The open label Phase 2 study was designed to evaluate ARIKACE over multiple treatment cycles in CF patients with Pseudomonas lung infections. The study enrolled 49 patients to receive ARIKACE 560 mg once daily for 28 days of therapy, followed by a 56-day off-treatment observation period. ARIKACE was administered using an optimized, investigational eFlow® Nebulizer System (PARI Pharma GmbH).

The data demonstrated that ARIKACE, delivered once-daily for 28 consecutive days, followed by 56 days off-treatment, for a total of six cycles, resulted in statistically significant improvement in lung function that was sustained over a 72 week period. Specifically, inhalation of 560 mg of ARIKACE produced a mean increase in pulmonary function (FEV1) of 11.7% at the end of the 28 day treatment period of the sixth cycle (p<0.0001).

During the course of the study, FEV1 improvement was also sustained at the end of 56 days off-treatment in each of cycles one through six, with an estimated relative increase in FEV1 of 5.7% (95% CI +3.0%, +8.5%; p=0.0001). Overall, ARIKACE was well-tolerated during all six cycles, with adverse events reported as consistent with those expected in a population of CF patients receiving inhaled medicines... Insmed's Press Release -

CytRx Increases Clinical Sites to 15 in Tamibarotene Phase 2b Clinical Trial in 1st Line Non-Small-Cell Lung Cancer to Expedite Patient Recruitment

Apr 20, 2011 - Clinical Trial Data Could Be Available in Second Half of 2012 - Development of Tamibarotene for Potential Multibillion Dollar Market is Major Priority for CytRx - CytRx Corporation (Nasdaq:CYTR), a biopharmaceutical company specializing in oncology, has expanded enrollment to 15 clinical sites in its Phase 2b clinical trial with tamibarotene in combination with chemotherapeutical agents for the treatment of patients with advanced non-small-cell lung cancer (NSCLC). The large number of sites is expected to accelerate recruitment, and full enrollment of the approximately 140 patients is now anticipated in 12 months.
"We have opened enrollment in 15 clinical sites in the U.S. and Mexico for our tamibarotene clinical trial in 1st line NSCLC to expedite recruitment for an indication that could represent a blockbuster opportunity," said CytRx CEO Steven A. Kriegsman. "We expect these additional sites will accelerate enrollment, which means we could have data from this Phase 2b clinical trial by the end of 2012. What makes NSCLC so compelling is that it is responsible for more deaths than breast, prostate and ovarian cancers combined."
Daniel Levitt, MD, Ph.D., CytRx's Chief Medical Officer, said, "Tamibarotene is 10 times more potent than all trans retinoic acid (ATRA), while simultaneously showing properties that suggest it may lead to fewer adverse effects than ATRA. Recent published clinical data demonstrated that ATRA in combination with chemotherapeutical agents was statistically significant as a treatment for advanced NSCLC, which may open the door for tamibartotene based on its greater potency and lower side effect profile than ATRA."
In December 2010, CytRx initiated the Phase 2b clinical trial in patients with advanced NSCLC at a single clinical site. In this randomized clinical trial, patients with advanced NSCLC are treated with paclitaxel plus carboplatin and either tamibarotene or placebo. The primary objective of this trial is to determine the objective response rate (complete and partial responses) and progression-free survival. Secondarily, the trial will evaluate overall survival, quality-of-life and examine the pharmacokinetics of tamibarotene in this population, among other measures... CytRx's Press Release -

Promedior : Clinical Data for PRM-151 (rhPTX-2) in Idiopathic Pulmonary Fibrosis at American Thoracic Society 2011

May 16, 2011 - Data Highlights Safety and Biomarker Activity in Patients with IPF – Promedior, Inc., a clinical stage biotechnology company developing novel therapies to treat fibrotic and inflammatory diseases, presented data from a clinical study of PRM-151 (recombinant human Pentraxin-2 (PTX-2)) at the 2011 American Thoracic Society International Conference (ATS 2011). The poster presentation entitled ”The Effects Of Recombinant Human Pentraxin-2, (PRM-151), On Circulating Fibrocytes In Idiopathic Pulmonary Fibrosis (IPF)” included clinical data from a completed Phase 1 study of PRM-151 that evaluated comprehensive safety endpoints and exploratory biomarker activity in healthy subjects and IPF patients. Across all study participants, PRM-151 was shown to be generally safe and well tolerated; and in a subset of study participants with IPF, PRM-151 showed activity against efficacy biomarkers through reductions in IPF-related blood fibrocytes levels and serum IL-6 levels.

"We are excited to present data from this clinical study, which underscore the potential of PRM-151 as a novel and powerful first-in-class agent to treat IPF, one of the most serious and difficult-to-treat fibrotic diseases... Promedior's Press Release -

Pfizer : The European Commission Approves Pfizer’s Revatio® (sildenafil) for the Treatment of Pulmonary Arterial Hypertension in Children

May 05, 2011 - New Indication Specifically for use in Pediatric Patients Based on Largest Placebo-Controlled Study Conducted in this Population - Pfizer Inc. announced that Revatio® (sildenafil citrate) has been approved by the European Commission for the treatment of pediatric patients aged 1 to 17 years old with pulmonary arterial hypertension. Efficacy in terms of improvement of exercise capacity or pulmonary hemodynamics has been shown in primary pulmonary hypertension and pulmonary hypertension associated with congenital heart disease.

“Pulmonary arterial hypertension is a rare, devastating disease that can affect children," said Dr. Cara Cassino, vice president, Pfizer Medicines Development Group. “With the approval of Revatio, these young patients now have an important treatment option that may help manage their condition. This approval is another example of our ongoing commitment to rare diseases.”

The approval was based on results of a dose-ranging phase 3 study that evaluated the efficacy and safety of Revatio versus placebo in 234 pediatric patients with primary pulmonary hypertension or pulmonary hypertension associated with congenital heart disease. The primary endpoint was improvement from baseline in exercise capacity as assessed by change in peak volume of oxygen consumption (peak VO2) following 16 weeks of treatment. In children who were deemed developmentally unable to perform the test due to young age or the presence of other conditions, efficacy was assessed using secondary endpoints, including hemodynamics and change in WHO functional class... Pfizer's Press Release -

Almirall strengthens its respiratory franchise with a new generation of Chronic Obstructive Pulmonary Disease (COPD) treatment

April 11th, 2011 - New class of dual action long-acting Muscarinic Antagonist Beta-2 Agonist (MABA) has potential to change the paradigm of COPD treatment - Almirall is aiming at starting clinical studies during first half of 2012 - Almirall strengthens its position in the respiratory field with apositive development progress of another New Chemical Entity (NCE). LAS190792 is a new dual long-acting Muscarinic Antagonist β2 Agonist (MABA), which combines two bronchodilator mechanisms in a single molecule for the treatment of COPD. This new class of inhaled long-acting bronchodilators is expected to provide additional symptom relief in patients living with COPD, and to form the basis of so called triple combinations together with ICS (inhaled corticosteroids). The MABA franchise (MABA and MABA/ICS combination) offer the convenience of different mechanisms of action in one inhaler therapy, and is envisaged to become a future block buster in COPD.

“Almirall’s MABA (LAS190792) represents an exciting opportunity for the treatment of COPD and shows the strength of Almirall´s commitment to research in respiratory disease”, said Dr Bertil Lindmark, MD, PhD, and Chief Scientific Officer at Almirall.

MABA compounds offer the advantage over the two-molecule bronchodilator combinations (LABA/LAMA), in that MABA/ICS combinations can be developed with a reasonable size development programme.

In preclinical models, LAS190792 has shown to have a long duration of action and high anti-muscarinic activity combined with β2 agonism. The molecule shows very favourable drug properties and safety.

Almirall is planning to priorize the finalization of the pre-clinical phase, aiming at starting clinical studies during first half of 2012.

LAS190792 will be developed in the Genuair® inhaler, a novel, state-of-the-art, multi-dose dry powder inhaler... Almirall's Press Release -

Sanofi-aventis and Regeneron : Top-line Results from Phase III Study with aflibercept (VEGF Trap) in Second-Line Non-Small Cell Lung Cancer

March 10, 2011 - Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) and Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) announced results from the Phase III VITAL trial evaluating the investigational agent aflibercept (VEGF Trap) for the second-line treatment of non-small cell lung cancer (NSCLC). The data showed that adding aflibercept to the chemotherapy drug docetaxel did not meet the pre-specified criteria for the primary endpoint of improvement in overall survival compared with a regimen of docetaxel plus placebo (HR=1.01, CI: 0.868 to 1.174). The addition of aflibercept to docetaxel demonstrated activity as measured by key secondary endpoints of the study: progression free survival (PFS) (HR=0.82, CI: 0.716 to 0.937) and an overall objective response rate (ORR) of 23.3% in the aflibercept arm compared to 8.9 percent in the placebo arm.


The treatment emergent adverse events (AEs) on the aflibercept arm with an incidence that was 10 percent greater than the control arm were stomatitis, weight decrease, hypertension, epistaxis and dysphonia. Grade 3 or 4 AEs that occurred at a frequency of at least 5 percent in patients who received aflibercept were fatigue, stomatitis, disease progression, hypertension, febrile neutropenia, dyspnea, neutropenia, and asthenia. AEs leading to treatment discontinuation occurred in 27.2 percent of patients in the aflibercept arm compared to 14.6 percent in the placebo arm. The types and frequencies of AEs reported in the aflibercept treatment arm were generally consistent with those reported in previous studies with anti-VEGF agents... [PDF] Sanofi-aventis' Press Release - Regeneron Pharmaceuticals' Press Release -

Revalesio : research on the anti-inflammatory effects of RNS60 in Asthma

March 16, 2011 – Revalesio Corporation announced that research related to the use of RNS60, its novel anti-inflammatory, will be featured in two poster presentations at the Annual Meeting of the American Academy of Allergy Asthma and Immunology (AAAAI) in San Francisco on March 18-22.
AAAAI is the largest professional organization in the United States devoted to the specialty of allergy and immunology. It has nearly 6,500 members in the United States, Canada and 60 other countries.
Revalesio will present findings that demonstrate the novel anti-inflammatory activity of charge-stabilized nanostructures both in a preclinical model of allergic asthma and in cell culture experiments. These data suggest that Revalesio’s novel therapeutic RNS60 provides an opportunity for the development of a new generation of low-risk therapeutics for inflammatory pulmonary diseases.

In the preclinical model of asthma, RNS60 showed significant efficacy in the reduction of key inflammatory cytokines, including interleukin-6, interleukin-4, tumor necrosis factor-α (TNF-α), eotaxin and other cytokines known to be drivers of asthma. In addition to reducing inflammatory cytokines, RNS60 improved respiratory parameters compared to treatment with the inhaled corticosteroid budesonide... Revalesio's Press Release -

FDA informs Novartis of extension to US regulatory review period for QAB149, a novel once-daily bronchodilator for treatment of COPD

March 23, 2011 - Novartis announced that the US Food and Drug Administration (FDA) has extended the regulatory review period for QAB149 (indacaterol) for the once-daily long-term maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

The FDA asked for a three-month extension in order to complete its review of the new drug application (NDA) for QAB149 by July 2011. In its notification, the FDA said it needed more time to examine the data submitted by Novartis in support of the application. The agency did not request additional data.

"This three-month extension reflects discussion at the advisory committee based on the comprehensive clinical program resulting in a large amount of data to be reviewed," said Trevor Mundel, MD, Global Head of Development at Novartis Pharma AG. "COPD is a life-threatening lung disease and a major cause of serious long-term disability[1]. We remain committed to bringing new therapies to patients who suffer from this condition."... Novartis' Press Release -

Stempeutics Research : DCGI nod to start Phase II clinical trial for four debilitating diseases

January 20 th, 2011 – Stempeutics Research a group company of Manipal Education & Medical Group announced that Drug Controller General of India (DCGI) has granted clearance of the company’s Investigational Medicinal Product “Stempeucel” for conducting Phase II clinical trials in patients with Osteo Arthritis, Diabetes Mellitus – Type2, Liver Cirrhosis and Chronic Obstructive Pulmonary Disease. Stempeucel product is developed from allogeneic mesenchymal stem cells derived from donated bone marrow using Stempeutics proprietary technology. Earlier the company has received approval from DCGI for Phase I/II clinical trial for Acute Myocardial Infarction and Critical Limb Ischemia in March 2009. Stempeutics is funded by Manipal Group and Cipla...


[...]

...Chronic Obstructive Pulmonary Disease

Chronic obstructive pulmonary disease (COPD) is a disease of the lungs in which the airways become narrowed. This leads to a restriction to the flow of air to and from the lungs causing shortness of breath. Currently the available treatment options are targeted at only symptomatic relief of COPD, which do not provide long term benefits to the patients. Mesenchymal stem cells are thought to stimulate the endogenous stem cells and help them to differentiate into alveolar epithelium, thus repairing the lung damage and improving pulmonary function. This study involves the evaluation of safety and efficacy of “Stempeucel” in COPD and finding the appropriate safe and effective dose for the disease... [PDF] Stempeutics Research's Press Release -

Forest Laboratories : FDA Approval of DalirespTM (Roflumilast) as a Treatment to Reduce the Risk of COPD Exacerbations in Patients with Severe COPD...

Mar 01, 2011 - Forest Announces FDA Approval of DalirespTM (Roflumilast) as a Treatment to Reduce the Risk of COPD Exacerbations in Patients with Severe COPD Associated with Chronic Bronchitis and a History of Exacerbations - Forest Laboratories, Inc. (NYSE: FRX) announced that Daliresp [TM] (roflumilast) was approved by the U.S. Food and Drug Administration (FDA) as a treatment to reduce the risk of chronic obstructive pulmonary disease (COPD) exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. The efficacy and safety of Daliresp was evaluated in eight clinical studies including 9,394 adult patients.

COPD is an under-diagnosed, progressive, irreversible lung disease. Symptoms of COPD include breathlessness, chronic cough and excessive production of phlegm. A significant worsening of symptoms - called an exacerbation - can last several weeks and often requires substantial medical intervention, including hospitalization.

Daliresp is the first and only selective phosphodiesterase-4 (PDE4) inhibitor approved and is an oral tablet taken once daily. While the specific mechanism by which Daliresp exerts its therapeutic action in COPD patients is not well defined, it is thought to be related to the effects of increased intracellular cyclic AMP in lung cells. Forest expects Daliresp to be available to wholesalers in the second calendar quarter of 2011... Forest Laboratories' Press Release -

Theratechnologies : new clinical program in muscle wasting in Chronic Obstructive Pulmonary Disease (COPD)

February 22, 2011 - Theratechnologies (TSX: TH) announced a new clinical program for muscle wasting in Chronic Obstructive Pulmonary Disease (COPD) using the Company's lead compound, tesamorelin, a human growth hormone releasing factor ("GRF") analogue.
Based on tesamorelin's anabolic properties, the Company has chosen to pursue the development of its lead compound in muscle wasting in patients with COPD as its second indication. COPD is characterized by progressive airflow obstruction due to chronic bronchitis or emphysema leading in certain cases to muscle wasting, a decrease of muscle mass and deterioration in functionality. Previously, Theratechnologies completed a Phase 2 trial in stable ambulatory COPD patients which demonstrated a statistically significant increase in lean body mass. The Company intends to commence a second Phase 2 clinical study in the second half of 2011 to test different dosages of tesamorelin with a new formulation... Theratechnologies' Press Release -

Helix BioPharma: European Clinical Trial Application For A Phase I/II Study Of Its Lung Cancer Drug Candidate L-DOS47

February 24, 2011 – Helix BioPharma Corp. (TSX, NYSE Amex, FSE: “HBP”), a developer of biopharmaceutical drug candidates for the prevention and treatment of cancer,announced that it has filed a clinical trial application (“CTA”) with the Central Register of Clinical Trials at the Polish Ministry of Health seeking approval to perform its planned Phase I/II clinical safety, tolerability and preliminary efficacy study of its lung cancer drug candidate L-DOS47.
L-DOS47 is Helix’s first therapeutic immunoconjugate drug candidate under development based upon the Company’s novel DOS47 technology, which is designed to modify the microenvironmental conditions of cancer cells in a manner that leads to their destruction.L-DOS47 is intended to offer an innovative approach to the first-line treatment of inoperable, locally advanced, recurrent or metastatic, non-small cell lung cancer (“NSCLC”)... [PDF] Helix BioPharma's Press Release -