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Nov 21, 2012

Ampliphi Biosciences : Encouraging Pre-Clinical Data on the Use of Phage-Based Therapies to Treat Bacterial Lung Infections

AmpliPhi Biosciences
October 18, 2012 - AmpliPhi Biosciences Corporation (APHB.PK) [‘AmpliPhi’] presented encouraging data from a pre-clinical animal model study of acute infection with Pseudomonas aeruginosa at the 26th Annual North America Cystic Fibrosis Foundation Conference held 11-13 October in Florida, USA (NACFC). The data generated in collaboration with scientists at Institut Pasteur in Paris and using AmpliPhi’s phage discovery platform show that the company’s proprietary mix of bacteriophage is able to clear lung infection with efficacy comparable or superior to a high dose of an antibiotic shown to be effective against the infecting bacteria in the laboratory. Furthermore, the bacteriophage therapy rapidly eradicates bacteria in the oropharynx and lungs of the infected mice. In fact, its action appears to be faster than the antibiotic, showing efficacy at just six hours, with reduced dissemination of the infection... source : AmpliPhi Biosciences' press release -

May 21, 2012

Chugai Pharmaceutical : Approval of an Orphan Drug, “Pulmozyme®,” a Recombinant Human Deoxyribonuclease I (rhDNase)

Chugai Pharmaceutical Roche Group
March 30, 2012 (Tokyo) - Chugai Pharmaceutical Co., Ltd. [Main Office: Chuo-ku, Tokyo. Chairman & CEO: Osamu Nagayama (hereafter, “Chugai”)] announced that it has obtained approval on March 30, 2012, from the Ministry of Health, Labour and Welfare (MHLW), for Pulmozyme® Inhalation Solution 2.5mg (hereafter, “Pulmozyme®”)[recombinant human deoxyribonuclease I (rhDNase), generic name: dornase alfa] for the indication of “improvement of pulmonary function in patients with cystic fibrosis.” Pulmozyme® is designated as an orphan drug for this indication by the MHLW.

As a result of the evaluation by the “Review Committee on Unapproved Drugs and Indications with High Medical Needs*” held on April 18, 2011, it was concluded that it is reasonable that dornase alfa be filed for approval in this indication based on available data, and on July 15, 2011, the filing was made using overseas data. In overseas clinical studies, administration of dornase alfa by inhalation is confirmed to be effective for the improvement of pulmonary function and reduction of the risk of serious infection of the respiratory tract in cystic fibrosis patients, compared to placebo... Chugai Pharmaceutical's Press Release -

Apr 24, 2012

Synairgen : Positive Phase II asthma clinical trial data

Synairgen
April 19, 2012 - Synairgen plc (LSE: SNG), announces positive data from its Phase II clinical trial. This pioneering trial investigated the potential for SNG001 (inhaled interferon beta) to protect asthmatics from respiratory virus infections (principally the common cold) that can spread to the lung, which are a major cause of worsening asthma symptoms. It is estimated that viral infection is associated with up to eight out of ten asthma-related emergency department visits.

There are 5.4 million asthmatics in the UK (Asthma UK) and 25.7 million in the USA (Centers for Disease Control and Prevention).

The study investigated SNG001 in a population of 134 adult asthma patients, representing 'mild-moderate' through to 'severe' asthmatics, who caught a cold. Patients with 'difficult to treat' asthma, being approximately half of the patients in the trial, benefitted significantly from SNG001 treatment. This category of patient is estimated to represent between 10% and 20% of all adult asthma sufferers... [PDF] Synairgen's Press Release -

Apr 4, 2012

Almirall and Menarini : licence agreement and commercial alliance for Aclidinium in the majority of European member states and a number of non-EU countries

Menarini
26 March 2012 - Almirall and Menarini sign a licence agreement and commercial alliance for Aclidinium in the majority of European member states and a number of non-EU countries -

  • Partnership fulfills Almirall's key criteria: territorial complementarity, non-competing portfolio assets, strong primary care capabilities and proven track record 
  • Aclidinium, a new therapeutic option, is awaiting regulatory feedback in the US and Europe, while partnerships have already been established in the US, Japan and Korea 
  • Chronic Obstructive Pulmonary Disease (COPD) affects nearly 44 million people in Europe1 and is considered by the World Health Organization (WHO) a global epidemic 
Almirall and Menarini announce an agreement by which Almirall grants Menarini marketing rights for Aclidinium in most EU and other European countries for the treatment of COPD. The agreement includes both aclidinium monotherapy and its combination with formoterol.

Menarini will have joint commercialisation rights across the majority of EU member states (excluding the UK, the Netherlands and the Nordic countries where Almirall retains sole marketing rights for the product) as well as Russia, Turkey and other CIS countries.

Almirall

In the territories for which Menarini holds rights to market aclidinium, it currently has a commercial infrastructure of over 5,000 sales representatives. These strong commercial capabilities and excellent track record in partnering have been key for Almirall in selecting Menarini. The commercial capabilities of Menarini are especially strong in Germany, Italy and France as well as Turkey, Central and Eastern Europe... Almirall's Press Release - Menarini's Press Release -

Mar 21, 2012

Covidien : Definitive Agreement to Acquire superDimension, Ltd.

Covidien
Mar. 19, 2012-- Covidien (NYSE: COV), a leading global provider of healthcare products, announced a definitive agreement to acquire superDimension, Ltd., a private company based in Herzliya, Israel, that develops minimally invasive interventional pulmonology devices.


Covidien will acquire all of the outstanding capital stock of superDimension Ltd., for approximately $300 million, with future earn out payments possible. The transaction, subject to customary closing conditions, including receipt of certain regulatory approvals, is expected to be completed in the second calendar quarter of 2012.



With annual sales of approximately $30 million, superDimension’s i·Logic™ System uses Electromagnetic Navigation Bronchoscopy® to provide minimally invasive access to lesions deep in the lungs as well as mediastinal lymph nodes. By extending the reach of conventional bronchoscopes, the i·Logic System facilitates more effective evaluation of lung lesions, potentially enabling safer, more effective tissue biopsies... Covidien's Press Release -

Mar 13, 2012

PhRMA : More Than 70 Medicines in Development for Asthma

PhRMA
March 5, 2012 — America’s biopharmaceutical research companies are developing 74 medicines to treat or prevent asthma, according to a report released today by the Pharmaceutical Research and Manufacturers of America (PhRMA). All of the medicines are either in clinical trials or awaiting review by the Food and Drug Administration.

“Asthma is a lifelong disease that can limit a person’s quality of life and even lead to death, if not treated properly,” said PhRMA President and CEO John J. Castellani. “The good news is that potential treatments highlighted in this report offer asthma sufferers new hope of living a healthier, more productive lives.”

Asthma is a narrowing of the airways to the lungs caused by inflammation in the air passages, resulting from both genetic and environmental influences. Today, more than 24 million American adults and children suffer from asthma, with the prevalence increasing 12 percent in the last decade, according to the Centers for Disease Control and Prevention. Each day, 40,000 Americans miss school or work due to asthma, costing the U.S. economy an estimated $56 billion each year in direct and indirect costs... PhRMA's Press Release -

Feb 13, 2012

Quanterix : to Collaborate With the Forsyth Institute and Beth Israel Deaconess Medical Center to Develop Tuberculosis Test

Quanterix
Feb. 9, 2012 - Partnership to Develop Innovative Pathogen Detection Test -

Quanterix Corporation, a company enabling a new generation of molecular diagnostic tests based on its revolutionary Single Molecule Array (SiMoA™) technology, announced that it will apply its cutting-edge technology towards the development of an improved test to aid in the diagnosis of active tuberculosis (TB). In collaboration with the Forsyth Institute and Beth Israel Deaconess Medical Center (BIDMC), Quanterix will validate novel low abundance protein biomarkers that may be useful for identifying individuals with active disease. Through this strategic partnership, Quanterix will continue to expand its infectious disease applications to include the development of a fast and simple test that will provide accurate diagnosis of active TB in high-burden countries.

"The Forsyth Institute has utilized a proteomics-based approach to identify a panel of novel M. tuberculosis markers present in the urine of human patients with active TB, but conventional protein detection platforms lack the analytical sensitivity to reliably detect these proteins in urine or blood. Using SiMoA, we are routinely able to improve the sensitivity of existing immunoassays by more than 1,000-fold, enabling accurate measurement of analytes that have previously been considered undetectable. Applying our technology to evaluate biomarkers that could not otherwise be detected will allow us to address a variety of important unmet medical needs, including the development of an improved test for the diagnosis of active tuberculosis," said David Duffy, Ph.D., Vice President of Research at Quanterix... Quanterix 's Press Release -

Feb 7, 2012

PhRMA : More Than 50 Medicines in Development for COPD, Third Leading Cause of Death in U.S.

Pharmaceutical Research and Manufacturers of America PhRMA
February 2, 2012 — America’s biopharmaceutical research companies are working on 54 medicines to treat chronic obstructive pulmonary disease (COPD), according to a report released by the Pharmaceutical Research and Manufacturers of America (PhRMA). These exciting therapies are in late-stage development, meaning they are either in clinical trials or awaiting review by the Food and Drug Administration (FDA).

Today, more than 13 million American adults suffer from COPD, one of the most common lung diseases in the U.S. A chronic, progressive lower respiratory disease that encompasses two main conditions – chronic bronchitis and emphysema – COPD is characterized by obstructed airflow to the lungs that interferes with normal breathing. People with COPD may be limited in their ability to work, exercise and perform routine activities.

According to the National Institutes of Health (NIH), the number of patients with COPD is increasing. In addition to those who have been diagnosed with the disease, 12 million Americans likely have COPD without knowing it.

“Early detection of COPD is imperative, as effective treatment can change the course and progression of this devastating disease,” said PhRMA President and CEO John J. Castellani. “The promising new therapies highlighted in this report illustrate how emerging scientific approaches to treating respiratory diseases such as COPD offer great hope to improve and save the lives of future patients.”... PhRMA's Press Release -

Jan 26, 2012

Uptake Medical : Australian Therapeutic Goods Administration Approval of InterVapor for Patients With Severe Emphysema

Uptake Medical
Dec. 21, 2011 – Uptake Medical® announced that it received Australian Therapeutic Goods Administration (TGA) approval for its InterVapor™ System for endoscopic lung volume reduction for the treatment of severe emphysema. InterVapor is the first non-surgical, endoscopic lung volume reduction system for the treatment of severe emphysema that uses the body’s natural healing processes without leaving implants or foreign materials in the lung.

Clinical efficacy of InterVapor has been established by the multi-center VAPOR trial which showed a reduction in lung volume as well as statistical and clinical significance in lung function improvement (FEV1) and health-related quality of life (SGRQ) at six months.

“Our involvement with Uptake Medical and InterVapor goes back to the first usage in patients, and we are delighted to see the TGA approval,” commented Professor Gregory Snell, head of lung transplant services at the Alfred Hospital in Melbourne, Australia. “InterVapor has continued to demonstrate clinical efficacy and safety and we look forward to offering InterVapor to our patients.”... Uptake Medical's Press Release -

Jan 19, 2012

NovaBiotics : plans for cystic fibrosis drug after EU grants orphan status

NovaBiotics
20th December 2011 - NovaBiotics reveals plans for cystic fibrosis drug after EU grants orphan status -

Bolstered by the an EU orphan drug designation for its drug candidate for cystic fibrosis, Lynovex (cysteamine), UK-based NovaBiotics revealed to Scrip that it plans to begin a first-in-man, safety/tolerability and evidence of efficacy study of the product in 2012, followed by other trials in 2013.

The company announced that the Committee on Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) has granted orphan status to the novel dual mucolytic-antibacterial drug for the treatment of cystic fibrosis and added that it is "currently in discussions with a number of interested parties with a view to licensing or co-developing the drug".

NovaBiotics stated it would "now progress with follow-on orphan applications for paediatric use and also applications for orphan drug designation in the US".

"This novel drug candidate is expected to be tested in patients in 2012," the biotech firm highlighted. It told Scrip that the study slated for next year would test Lynovex when used in conjunction with conventional inhaled ABX (antibiotic) therapies in the first instance. In 2013, NovaBiotics said it would initiate a second and third trial to further assess efficacy.

The company confirmed that it intends to partner the product, and "as per our core business model [this is] most likely after the second clinical study". With respect to its finances, it said: "NovaBiotics remains fully equity funded (still pre-revenue) and this is how development has been/will be funded in the short-term for Lynovex, but as the programme develops towards final clinical studies, revenue from Novexatin and Luminaderm commercialisation deals will be reinvested into the Lynovex programme."... NovaBiotics' Press Release -

Jan 12, 2012

Geron : Phase 2 Trial of GRN1005 in Brain Metastases From Lung Cancer

Geron
December 22, 2011 - Geron Corporation (Nasdaq: GERN) announced the initiation of GRABM-L (GRN1005 Against Brain Metastases - Lung cancer), a Phase 2 clinical trial to evaluate GRN1005 in patients with brain metastases arising from non-small cell lung cancer (NSCLC). GRN1005 is the company's lead LRP-directed peptide-drug conjugate (LRP-directed PDC) and consists of the cytotoxic drug paclitaxel linked to a peptide (Angiopep-2) that targets the LRP receptor to cross the blood-brain barrier (BBB) and to target tumors in the brain.

"With the treatment of the first patient in the GRABM-L study, we have initiated both of the planned Phase 2 clinical trials of GRN1005 in patients with cancer metastases in the brain, a significant unmet medical need for which there are currently no approved drug therapies," said Stephen M. Kelsey, M.D., Geron's Executive Vice President, Head of R&D and Chief Medical Officer. "We have been encouraged by the preliminary evidence of anti-tumor activity against brain metastases observed in the Phase 1 study of GRN1005, and we hope to confirm these results in our Phase 2 trials."

Phase 2 Clinical Trial Design (GRABM-L) 

The purpose of the Phase 2 study is to assess the efficacy, safety and tolerability of GRN1005 in patients with brain metastases from NSCLC. The trial plans to enroll 50 patients.

GRN1005 will be administered at a dose of 650 mg/m2 by intravenous (IV) infusion every three weeks. The primary efficacy endpoint for the trial is overall (intra-cranial and extra-cranial disease) objective response rate. Key secondary endpoints include duration of overall objective response, duration of overall progression-free survival and six month overall survival....Geron's Press Release -

Jan 6, 2012

Orchid Pharma : successful completion of Phase I study of its novel PDE4 inhibitor molecule, OCID 2987

Orchid Pharma
January 02, 2012 - The Chennai-based global pharma major, Orchid Chemicals & Pharmaceuticals (Orchid) stated that it has successfully completed in Europe a Phase I trial of its orally administered PDE4 (phosphodiesterase 4 inhibitor) molecule OCID 2987 positioned for the treatment of inflammatory disorders including COPD (Chronic Obstructive Pulmonary Disease).

The Phase I study was conducted to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic effects of OCID 2987 at escalating single or repeated doses on healthy male volunteers. OCID 2987 was well tolerated up to the highest doses administered in both single and repeat dose studies and did not demonstrate a potential for nausea/emesis, a common unacceptable side-effect with most PDE4 inhibitors. There were no serious adverse events or any cardiac safety concerns reported in the study... Orchid Pharma's Press Release -