KaloBios, Phase 1/2 Trial of KB002 Engineered Monoclonal Antibody in Persistent Asthma

March 10, 2008 – KaloBios Pharmaceuticals, Inc., a privately held biopharmaceutical company, announced the initiation of a Phase 1/2 clinical study of KB002, the company’s anti-GM-CSF monoclonal antibody, as a potential treatment for persistent asthma. The blinded, placebo-controlled study, which is being conducted at over five sites in Australia, will enroll up to 24 patients who will receive either KB002 or placebo. Endpoints for the study will include safety, measurements of Forced Expiratory Volume (FEV1 – a measurement of expiratory air flow), and inflammatory markers... KaloBios' Press Release -

Cerner and UNMHSC, agreement to evaluate dry-powder inhaler drug-delivery technology

March 11, 2008 – Cerner Corporation (NASDAQ: CERN), the University of New Mexico Health Sciences Center (UNMHSC) College of Pharmacy, the UNM School of Engineering and STC.UNM (STC), the University’s technology-transfer corporation, announced the signing of a Sponsored Research Agreement to evaluate UNMHSC’s dry-powder inhaler (DPI) drug-delivery technology for use in both pulmonary and systemic conditions, like asthma and chronic obstructive lung disease. Upon completion of the research studies, the agreement provides Cerner an option for exclusive licensing of UNMHSC’s technology for clinical and commercial use worldwide... Cerner 's Press Release -

Talecris Biotherapeutics, 20th Anniversary of Launch of Prolastin

(Feb. 21, 2008) — Talecris Biotherapeutics, Inc., a leading global biotherapeutics and biotechnology company, is celebrating the 20th anniversary of the launch of Prolastin^® (Alpha1-Proteinase Inhibitor [Human]). Prolastin is the market leader among alpha1-antitrypsin (AAT) augmentation therapies and is used to treat people with AAT deficiency, or Alpha-1, who have developed emphysema as a result of low circulating levels of AAT. AAT deficiency is an inherited condition thought to affect as many as 150,000 people in North America and Europe, although only an estimated five percent have been diagnosed. Prolastin was the first plasma-derived AAT augmentation therapy to receive approval from the U.S. Food and Drug Administration (FDA). Approved in December 1987, and launched in February 1988, Prolastin was the first FDA-approved product for AAT augmentation therapy for Alpha-1 patients and remained so for nearly 17 years...
...Before Prolastin was approved, people with Alpha-1 received only supportive therapy for their pulmonary symptoms but did not have access to a specific therapy that raises AAT (anti-elastase) levels above the protective threshold to preserve lung function... Talecris' Press Release -

Amira Pharmaceuticals and GSK, global agreement for FLAP inhibitor programme

4-February-2008: Amira Pharmaceuticals and GlaxoSmithKline enter global agreement for FLAP inhibitor program. Deal follows positive phase I data from novel product candidate AM103 for the oral treatment of respiratory diseaseAmira Pharmaceuticals and GlaxoSmithKline today announced they have entered into a worldwide exclusive agreement to develop, manufacture and commercialize FLAP (5-Lipoxygenase Activating Protein¬) inhibitors for the treatment of respiratory and cardiovascular disease... Amira Pharmaceuticals' Press Release - GlaxoSmithKline's Press Release -

Asthmatx, Bronchial Thermoplasty in Refractory Asthma Results

Sunnyvale, CA, February 11, 2008 – Asthmatx, Inc., a medical device company that has developed a catheter-based procedure under investigation for the treatment of asthma, announced today the publication of data from the Research in Severe Asthma (RISA) Trial of bronchial thermoplasty in the American Journal of Respiratory and Critical Care Medicine (AJRCCM, 2007; 176:1185-1191). The publication reports that despite a transient increase in procedure related adverse events, patients experienced longer term improvement in pulmonary function, improved quality of life and asthma control, and a reduction in rescue medication use for patients treated with bronchial thermoplasty.

Bronchial thermoplasty is a non-drug treatment for asthma and is currently under clinical investigation. Bronchial thermoplasty is an investigational procedure in which precisely controlled thermal energy is delivered with a tiny catheter to targeted airway walls of patients with asthma. This procedure is intended to reduce muscle in the walls of airways, and thereby decrease the ability of airways to narrow in patients with symptomatic asthma... Asthmatx's Press Release -

Orexo, eoxins, new mechanism for asthma and COPD treatment

2008-01-10 - The discovery of the eoxins and their characteristics has paved the way for a new class of pharmaceuticals for treatment of asthma and COPD. One of the world’s most-cited scientific journals, Proceedings of the National Academy of Sciences of the United States (PNAS), is now publishing Orexo´s research on the initial discovery and biological functions of eoxins. The publication describes the scientific rationale behind Orexo´s drug development program on eoxin inhibitors.Eoxins constitute a new group of inflammatory mediators, which adds to understanding the mechanisms for airway inflammation. Eoxins are pro-duced from the endogenous fatty acid arachidonic acid, via the initial action of the enzyme 15-lipoxygenase. Inflammatory cells in the res-piratory tract are the main producers of eoxins, and the production is initiated by well known inflammatory mediators released in connection with allergy and asthma. These data, together with the powerful pro-inflammatory effects demonstrated for the eoxins, indicate an important role for eoxins in the inflammation seen in connection with asthma and COPD, chronic obstructive pulmonary disease... Orexo´s Press Release -

Boehringer Ingelheim’s BIBW 2992 for the treatment of late stage non small cell lung cancer (NSCLC)

14 February 2008 – Boehringer Ingelheim’s investigational cancer treatment BIBW 2992 has recently received a Fast Track Designation status by the FDA. Under this designation, Boehringer Ingelheim will conduct a pivotal trial programme studying BIBW 2992 in a non-small cell lung cancer (NSCLC) patient group where prior treatment with reversible EGFR inhibitors has failed.
The FDA`s Fast Track Programme will facilitate the development programme and expedite the review of new treatments that demonstrate the potential to address an unmet medical need in serious or life-threatening diseases... Boehringer Ingelheim’s Press Release -

AstraZeneca RECENTIN BR24 Non-Small Cell Lung Cancer Trial Will Not Progress

27 February 2008 - ... AstraZeneca also announced that the National Cancer Institute of Canada Clinical Trials Group (NCIC-CTG) has informed AstraZeneca that the BR24 Phase II/III study of RECENTIN at 30mg in first line non-small cell lung cancer (NSCLC) will not continue into Phase III following the planned end of Phase II efficacy and tolerability analysis by the study’s Data Safety Monitoring Committee. Although evidence of clinical activity was seen, there appeared to be an imbalance in toxicity and therefore the study was considered not to have met the pre-defined criteria for automatic continuation into Phase III... AstraZeneca's Press Release -

Aerocrine, Chest M.I. market and sell NIOX MINO in Japan

February 11, 2008 – Aerocrine AB (OMX Nordic Exchange: AERO) announces that the company has entered into a distribution agreement with Chest M.I. Inc. Chest will market and sell NIOX MINO® in Japan.Chest manufactures and sells a large range of products to measure lung function as well oxygen delivery systems for home use.
The company which was founded in 1965 is one of the largest companies in its field with over 50% share of the Japanese market.Chest has an impeccable reputation and impressive market coverage with over 10 local sales offices. Chest will apply for market authorization of NIOX MINO in Japan and then proceed to product launch... [PDF] Aerocrine's Press Release-

N30 Pharma, Successful Initiation of Human Studies with N30-201

Jan. 28, 2008 - N30 Pharma (N30), a biopharmaceutical company focused on the discovery, development, and commercialization of respiratory drugs that target endogenous s-nitrosothiols, announced today that it has successfully completed Phase 1 study of N30-201 in healthy volunteers.
N30 intends to develop N30-201 for the treatment of reactive and obstructive airway diseases, including Cystic Fibrosis and asthma... N30 Pharma's Press Release -

Glenmark, USD 15 million as milestone payments from Forest for Oglemilast, GRC 3886

February 06, 2008 – Glenmark Pharmaceuticals Ltd. [Glenmark], announced that its wholly owned Swiss subsidiary Glenmark Pharmaceuticals SA (GSA), has received a milestone of USD 15 Million from Forest Labs, which is Glenmark’s North American partner for Oglemilast (GRC 3886). This follows a favourable response from USFDA, allowing Forest to initiate an additional Phase II study in COPD for Oglemilast. Glenmark and Forest Labs are working together closely to initiate additional studies for further longer term development of Oglemilast, including a Phase II study in Asthma... [PDF] Glenmark Pharmaceuticals' Press Release -

BioMarck Pharmaceuticals, FDA Agreement on its Phase 2 Clinical Trial Plans

Jan. 29, 2008 - BioMarck Pharmaceuticals, a biopharmaceutical research and development company focused on new therapies for the treatment of respiratory diseases, announced that it has obtained agreement from the U.S. Food and Drug Administration (FDA) for its proposed plans for a Phase 2 trial of the novel respiratory drug, BIO-11006 Inhalation Solution.

Phase 1 studies of BIO-11006, an inhaled drug designed to combat the oversecretion of mucus and inflammation in diseases such as chronic obstructive pulmonary disease (COPD), asthma, and cystic fibrosis, were conducted on healthy volunteers and have demonstrated that the treatment is safe and well tolerated... [FLASH] BioMarck's Press Release -

ADVENTRX, Complete ANX-530 Pharmacokinetic Data at the 2008 American Association for Cancer Research Annual Meeting

Feb. 7, 2008 - ADVENTRX Pharmaceuticals, Inc. (Amex: ANX), announced that complete pharmacokinetic data from the Company's marketing-enabling bioequivalence clinical study of ANX-530 (vinorelbine emulsion) has been accepted for presentation at the 2008 American Association for Cancer Research (AACR) Annual Meeting, which takes place April 12 - 16, 2008 in San Diego, CA...
... ANX-530 is designed to reduce the incidence and severity of injection site reactions from intravenous delivery of vinorelbine tartrate. Vinorelbine tartrate works by disrupting microtubule formation and is a member of the vinca alkaloid class of antineoplastic agents. Vinorelbine is indicated as a single agent or in combination with cisplatin for treatment of advanced non-small cell lung cancer and has also shown activity in breast, ovarian, and other cancers...ADVENTRX's press Release-

Hana Biosciences, Top-Line Phase 1 Clinical Trial Data Demonstrating Alocrest to be Well-Tolerated With Promising Anti-Tumor Activity

Calif., Feb. 12, 2008 - Hana Biosciences (Nasdaq:HNAB), a biopharmaceutical company focused on strengthening the foundation of cancer care, today announced that the company has completed patient enrollment in its Phase 1 dose-escalation clinical trial of Alocrest(tm) (vinorelbine liposomes injection, OPTISOME(tm)). This trial was designed to assess the safety, tolerability and preliminary efficacy of Optisomal encapsulated vinorelbine, or Alocrest...
... Alocrest is a novel sphingomyelin/cholesterol liposome-encapsulated vinorelbine tartrate formulation. Vinorelbine, a semi-synthetic vinca alkaloid, is a microtubule inhibitor that has been approved for use as a single agent or in combination with cisplatin for the first-line treatment of advanced non-small cell lung cancer... Hana Biosciences' Press Release -