NuRx Pharmaceuticals : Phase I Clinical Trial of First-in-Class RXR Agonist NRX4204

March 24, 2008 - NuRx Pharmaceuticals, Inc. (OTCBB: NURX) announced it has dosed the first patient in a Phase I clinical trial of the first-in-class rexinoid receptor (RXR) agonist NRX4204.

The single-center study, which NuRx expects to complete in the fourth quarter of this year, is designed to evaluate the safety and tolerability of the compound. NRX4204 is the company's first drug candidate in clinical trials.

"Our preclinical data show that NRX4204 is a highly potent and specific, orally bio-available RXR agonist that is effective in models of non-small cell lung cancer and breast cancer... NuRx Pharmaceuticals' Press Release -

Replidyne Discontinues Phase III Trial

April 23, 2007 - Replidyne, Inc. (Nasdaq: RDYN) announced that it has discontinued enrollment in a placebo-controlled Phase III clinical trial testing faropenem medoxomil (faropenem) in patients with acute exacerbation of chronic bronchitis (AECB). Replidyne took this action to conserve its cash assets and support initiatives that include pursuing strategic transactions and maintaining its research programs... Replidyne's Press Release -

InterMune : Progress on Pirfenidone in Idiopathic Pulmonary Fibrosis (IPF)

April 21, 2008 - InterMune, Inc. (Nasdaq: ITMN) announced that it will initiate an open-label roll-over study to evaluate the long-term safety of pirfenidone in patients with idiopathic pulmonary fibrosis (IPF). The roll-over study will be open to patients who complete one of the two concurrent Phase 3 CAPACITY studies of pirfenidone in IPF. InterMune expects that the first patient will enter the roll-over study in August 2008... InterMune's Press Release -

MedImmune and Infinity : Preclinical Data Highlighting Potential of Retaspimycin in Treating Non-Small Cell Lung Cancer With Acquired Drug Resistance

April 15, 2008 – Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) and MedImmune announced that preclinical studies evaluating lead drug candidate retaspimycin hydrochloride ("retaspimycin," also known as IPI-504) suggest that retaspimycin represents a novel strategy for the potential treatment of patients with non-small cell lung cancer (NSCLC) who exhibit resistance to Iressa® (gefitinib) or Tarceva® (erlotinib). Data were presented today during the Annual Meeting of the American Association of Cancer Research (AACR) in San Diego, California. Retaspimycin, a selective small molecule inhibitor of heat shock protein 90 (Hsp90), is currently being evaluated in the Phase 2 portion of an ongoing Phase 1/2 clinical trial in patients with advanced non-small cell lung cancer... MedImmune's Press Release - Infinity's Press Release -

Diffusion Pharmaceuticals : patent no. 7,351,844 entitled “Bipolar Trans Carotenoid Salts and Their Uses.”

April 8, 2008 – Diffusion Pharmaceuticals LLC, a clinical-stage drug-development company commercializing drugs utilizing a novel method of action that enhances oxygen diffusion, announced that it has been granted U.S. patent no. 7,351,844 entitled “Bipolar Trans Carotenoid Salts and Their Uses.” This patent includes claims to a family of first-in-class new chemical entities, known as trans biopolar carotenoid (or TBC) molecules. In addition, the Company also announced it has been granted corresponding patents from the South African and the New Zealand Patent Offices. “The issuance of these patents is a vital step in our intellectual property development strategy, furthering our goal of bringing Diffusion Pharmaceutical’s first-in-class therapeutics to market. Our highly unique compounds may one day treat patients with a broad range of disorders involving hypoxia... Diffusion Pharmaceuticals' Press Release -

Micromet : Phase 1 Clinical Trial with MT110, the First BiTE Antibody for Treatment of Solid Tumors

April 23, 2008 - Micromet, Inc. (Nasdaq: MITI), a biopharmaceutical company developing novel, proprietary antibodies for the treatment of cancer, inflammation and autoimmune diseases, announced the start of a phase 1 clinical trial with its BiTE(R) antibody MT110. The study will explore the safety, pharmacokinetics, pharmacodynamics and anti-tumor activity of MT110 in patients with lung and gastrointestinal cancers. MT110 targets the epithelial cell adhesion molecule (EpCAM or CD326), which is highly expressed on colon, lung, breast, prostate, ovarian, gastric and pancreas cancers... Micromet's Press Release -

Sorin : approval to market heart-lung machine in Japan

April 21, 2008 – The Sorin Group, the largest European cardiovascular company and world leader in medical technologies for cardiac surgery, announces that it received the Japanese Pharmaceutical and Medical Devices Agency's (PMDA) approval to market its Stöckert S5 Heart-Lung Machine in Japan.

Every year, over one million patients in the world undergo life-saving open-heart procedures supported by heart-lung machines.
With more than 30 years of experience in the cardiopulmonary business field, the Sorin Group is the undisputed leader in the manufacturing and marketing of heart-lung machines, with a share of over 60% of the installed base of machines... Sorin's Press Release -

Gene Express : licensing agreement with University of South Florida

04.21.08 - Gene Express, Inc. announced that it has signed an agreement with the Division of Patents & Licensing Research Office at the University of South Florida (USF) to license some of their gene expression technology necessary to develop prognostic tests for cisplatin and irinotecan chemoresistance.

The ability to assess patients for resistance to chemotherapeutics prior to chemotherapy would offer physicians an important tool in providing appropriate chemotherapy to patients afflicted with cancers of the lung and colon. Mechanisms of chemoresistance likely involve multiple gene products involved in DNA repair, drug uptake and other unspecified processes... Gene Express' Press Release -

Genentech : "AVAiL" Phase III Study of Avastin Plus Chemotherapy in First-Line, Advanced, Non-Squamous, Non-Small Cell Lung Cancer

april 20, 2008 -- Genentech, Inc. (NYSE: DNA) announced an update for the previously reported Roche-sponsored international Phase III clinical study (AVAiL) of Avastin® (bevacizumab) in combination with gemcitabine and cisplatin chemotherapy, in patients with advanced, non-squamous, non-small cell lung cancer (NSCLC). The update confirmed the clinically and statistically significant improvement in the primary endpoint of progression free survival (PFS) for the two different doses of Avastin studied in the trial (15 mg/kg and 7.5 mg/kg) compared to chemotherapy alone. The study did not demonstrate a statistically significant prolongation of overall survival, a secondary endpoint, for either dose in combination with gemcitabine and cisplatin chemotherapy compared to chemotherapy alone. Median survival of patients in all arms of the study exceeded one year, longer than previously reported survival times in this indication... Genentech's Press Release -

Spectrum Pharmaceuticals : Preclinical Data Demonstrates Potential Applications In Lung Cancer Therapy

April 17, 2008- Spectrum Pharmaceuticals, Inc., (Nasdaq:SPPI) announced preclinical data on lucanthone via poster presentation at the 2008 Annual Meeting of the American Association of Cancer Research (AACR), held in San Diego, California. Lucanthone is an orally administered small molecule inhibitor of DNA repair. The Company is expected to initiate shortly a Phase I dose-escalation study of lucanthone in patients with recurrent malignant gliomas receiving temozolomide. Data presented demonstrates that lucanthone improves the activity of pemetrexed (Alimta(R), Eli Lilly & Co.) in lung cancer animal models... Spectrum Pharmaceuticals' Press Release -

Kosan : Phase 2 Trial of Epothilone KOS-1584 in Non-Small Cell Lung Cancer

April 14, 2008 - Kosan Biosciences Incorporated (Nasdaq: KOSN) announced that the Phase 2 trial of epothilone KOS-1584 in patients with non-small cell lung cancer has been initiated. The Phase 2 trial is an open-label, multi-center, monotherapy study of KOS-1584 in patients with measurable advanced or metastatic non-small cell lung cancer who have previously received only one prior chemotherapy regimen. The primary endpoint of the Phase 2 trial is objective response rate. Secondary endpoints include progression-free survival, time to progression, time to treatment failure, time to response, duration of response and overall survival. KOS-1584 will be administered via a 3-hour intravenous infusion weekly for two weeks out of every three weeks at a dose of 25 mg/m(2). The Phase 2 trial will enroll up to 50 patients in a two-stage Simon design... Kosan Biosciences' Press Release -

Infinity Pharmaceuticals' Hedgehog Antagonist Delays Tumor Growth Following Chemotherapy in Preclinical Model of Small Cell Lung Cancer

Apr 15, 2008, 2008 - Infinity Pharmaceuticals, Inc. (Nasdaq:INFI) announced that preclinical data from a model of small cell lung cancer (SCLC) show that following treatment with chemotherapy, once-daily oral administration of IPI-926 leads to a statistically significant delay in tumor re-growth, compared to vehicle control (p=0.01). These results suggest that inhibiting the Hedgehog pathway with IPI-926, Infinity's novel, potent Hedgehog pathway antagonist following chemotherapy delays tumor recurrence in SCLC. These data were presented today during the Annual Meeting of the American Association of Cancer Research (AACR) in San Diego, California... Infinity Pharmaceuticals' Press Release -

Oncolytics Biotech : Dose Escalation in Combination REOLYSIN®/Paclitaxel and Carboplatin Trial

4/14/2008 - April 14, 2008 - Oncolytics Biotech Inc. (“Oncolytics”) (TSX:ONC, NASDAQ:ONCY) has completed patient enrolment in the dose escalation portion of its U.K. clinical trial to evaluate the anti-tumour effects of systemic administration of REOLYSIN® in combination with paclitaxel and carboplatin in patients with advanced cancers including head and neck, melanoma, lung and ovarian... Oncolytics Biotech's Press Release -

Alfacell's ONCONASE : Potential as Radiation Sensitizer for Lung Cancer Treatment

April 14, 2008 - Alfacell Corporation (NASDAQ:ACEL) announced that Dr. Intae Lee with the University of Pennsylvania has reported that Alfacell's ONCONASE (ranpirnase) could be a promising radiation sensitizer for lung cancer treatment. Dr. Lee presented the pre-clinical in vivo and in vitro data in a poster at the 2008 American Association of Cancer Research (AACR) Annual Meeting being held April 12 - 16 in San Diego.

In the poster titled "The inhibition of radiation repair by ranpirnase +/- I-buthionine sulfoximide on lung cancer," Dr. Lee provided pre-clinical evidence that ONCONASE +/- I-buthionine sulfoximide significantly increased the radiation-induced growth delay of lung tumors in vivo without increases in skin reaction, compared to radiation alone. Additionally, in vivo and in vitro data presented indicated that ONCONASE significantly increased apoptosis (programmed cell death) in several human non-small cell lung cancer (NSCLC) cell lines (A549, NCI-H1975 and HOP-62). Dr. Lee and his team of researchers also showed that the radiation repair mechanisms known as sub-lethal damage repair (SLDR) and potentially lethal damage repair (PLDR), which lead to radiation resistance in tumors, were significantly inhibited by ONCONASE in vitro... Alfacell's Press Release -

Lilly's ALIMTA : European Approval for Histologically-Based Use in First-Line Treatment of Most Common Lung Cancer

Apr 11, 2008 - Approval Marks Third European Indication for ALIMTA

Eli Lilly and Company (NYSE: LLY) announced that European health authorities have approved the use of ALIMTA® (pemetrexed for injection) for a histologically-based use in the first-line treatment of advanced non-small-cell lung cancer (NSCLC), the most common form of lung cancer. This approval - the third for pemetrexed in Europe - follows an initial positive opinion issued by the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) on February 21, 2008.

The EMEA specifically approved pemetrexed in combination with cisplatin as a first-line treatment for NSCLC patients with other than predominantly squamous cell histology. Histology is the microscopic study of tissue and NSCLC is classified by its histology. Previously, all histologies were treated similarly... Lilly's Press Release -

Rosetta Genomics : Agreement With West Coast CLIA Certified Lab to Develop and Validate Tests Applying Company's MicroRNA Technology

April 14, 2008- Rosetta Genomics, Ltd. (Nasdaq:ROSG), a leader in the development of microRNA-based diagnostic and therapeutic products, announced it has signed an agreement with University of California, Irvine School of Medicine (UC Irvine), relating to the development and validation of diagnostic tests based on the company's microRNA technology. The tests are designed to differentiate squamous versus non-squamous lung cancer, differentiate mesothelioma from adenocarcinoma, and identify cancers of unknown primary (CUP) origin... Rosetta Genomics' Press Release -

Pharmaxis : CF Trial in Children Returns Positive Data

04 April 2008 - Pharmaxis Ltd (ASX:PXS; NASDAQ: PXSL) announced that a Phase II clinical trial in children with cystic fibrosis demonstrated excellent lung function improvement following three months treatment with Bronchitol that matched that achieved by the current marketed product rhDnase1. The improvement in lung function after three months on Bronchitol reflects that seen in a previous study following two weeks of treatment.

The study was an independent investigator initiated study conducted in the United Kingdom in 20 children with a mean age of 13 years. Those children enrolled in the trial completed three months treatment with each of three different therapies – Bronchitol alone, both Bronchitol and rhDNase together and rhDNase alone. The trial measured changes in lung function, airway inflammation, infections, and quality of life... Pharmaxis' Press Release -

MedImmune : Asthma Program with Start of a Phase 2 Trial in Europe and Australia and First U.S.-Based Clinical Trial for Antibody Targeting IL-13

April 15, 2008 - MedImmune announced that it has advanced its efforts to develop CAT-354, a potential treatment for patients with asthma, with the start of two new trials with a monoclonal antibody (MAb) targeting interleukin-13 (IL-13). One of the studies is a Phase 2 clinical trial in Europe and Australia designed to assess the potential of the anti-IL-13 MAb in patients with uncontrolled asthma despite optimal treatment. The company has also begun dosing patients in the first U.S.-based clinical trial of the antibody, a Phase 1 study to assess pharmacokinetics in healthy adult patients... MedImmune's Press Release -

Transave : Study Confirms Anti-Infective ARIKACE Effectively Penetrates Mucus and Biofilm, and Kills Pseudomonas, a Bacteria Plaguing Cystic Fibrosis

March 31, 2008 – Transave Inc. reported today that its lead product candidate, ARIKACE™ (liposomal amikacin for inhalation), may have the ability to penetrate mucus and biofilms, and decrease the number of Pseudomonas aeruginosa lung infections in patients with cystic fibrosis, according to results of a study published in the Journal of Antimicrobial Chemotherapy.

Results of the study titled "Biofilm penetration, triggered release and in vivo activity of inhaled liposomal amikacin in chronic Pseudomanas aeruginosa lung infections," were published in the April issue of the journal. Transave is a biopharmaceutical company focused on the development of next-generation liposomal drug products for inhalation.

ARIKACE is a form of the antibiotic amikacin, which is enclosed in nanocapsules of lipids called liposomes... Transave's Press Release -

Antisoma and Novartis : phase III lung cancer trial of ASA404

11 April 2008 – Cancer drug developer Antisoma plc (LSE: ASM; US OTC: ATSMY) announces that its partner Novartis has started the pivotal phase III trial of ASA404 combined with first-line chemotherapy in non-small cell lung cancer (NSCLC). The study, called ATTRACT-1, is designed to support applications for marketing authorisations in the US, Europe and other territories.

Its initiation triggers a USD 25 million milestone payment to Antisoma... Antisoma's Press Release - Novartis' Press Release -

UCB : Phase II results for CDP791 in non-small cell lung cancer support further clinical development

March 31, 2008 - UCB announces first results of its phase II exploratory study of CDP791, a specific VEGFR-2/KDR inhibitor, in combination with carboplatin and paclitaxel chemotherapy in first line non-small cell lung cancer (NSCLC). Positive improvements were observed on several efficacy endpoints including tumour response rate and time to tumour progression. The data support further late stage clinical development of the drug in first line NSCLC. UCB will now work on the consequent clinical development plans and is evaluating partnership options... UCB's Press Release -

Dinamika : A New Asthma Treatment Introduced by Russian Scientists

2008/04/03 -A new treatment without medication has recently been announced and claimed effective by a group of Russian researchers who have found and tested it, and are now ready to introduce the invention to the world market. The treatment implies learning particular respiratory patterns through practising breathing exercises with Frolov's® Respiration Training Device, the rights for manufacturing of which now belong to a Russian company Dinamika.
Novosibirsk, Russia -- Contemporary asthma treatment can be different according to the severity of asthma symptoms in each patient. There are three main types of treatment: medication, desensitization (when the body gradually adapts to the allergen) and respiratory exercises, which are known as Buteyko therapy... Dinamika 's Press Release -

SkyePharma : exclusive License Agreement with Kyorin for Development and Distribution of Flutiform in Japan

22 April, 2008 - SkyePharma PLC (LSE: SKP) announces that it has entered into an exclusive Development, Distribution and License Agreement for Flutiform(TM), its lead development product for the treatment of asthma, with Kyorin Pharmaceutical Co., Ltd., a subsidiary of Kyorin Co., Ltd. for Japan. SkyePharma will receive signing, development and approval milestones worth several millions of pounds plus a high mid-single digit royalty on sales.The development costs associated with obtaining approval for the Japanese market will largely be met by Kyorin, which is responsible for clinical trials and regulatory submissions. Development is expected to take several years... SkyePharma's Press Release -

eResearchTechnology, Inc. and nSpire Health, Inc. : Alliance to Deliver Integrated Cardiac Safety and Pulmonary Trial Services

April 14, 2008 - eResearchTechnology, Inc. (eRT), (Nasdaq: ERES), and nSpire Health, Inc. announced today their alliance to provide integrated Cardiac Safety and Pulmonary Core Lab Services to clinical researchers worldwide.
eResearchTechnology is a leading provider of centralized electrocardiographic (ECG), eClinical technology, ePRO, and other services to the pharmaceutical, biotechnology, medical device, and related industries.

nSpire Health is a leading provider of respiratory clinical trials services, including Cardiopulmonary Exercise Testing, High Definition Pulmonary Diagnostics Systems, Spirometry, and Home Monitoring... nSpire Health's Press - eResearchTechnology's Press release -

Alnylam : ALN-RSV01 in Adult Lung Transplant Patients Naturally Infected with Respiratory Syncytial Virus (RSV) Infection

April 9, 2008- Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced it has initiated a Phase II clinical trial to assess the safety and tolerability of aerosolized ALN-RSV01 versus placebo in adult lung transplant patients naturally infected with RSV. As a secondary objective, this trial will be the first to evaluate the anti-viral activity of ALN-RSV01 in a naturally acquired RSV lower respiratory tract infection... Alnylam's Press Release -

Critical Therapeutics : Phase I Clinical Trial of the R(+) Isomer of Zileuton

April 8, 2008- Critical Therapeutics, Inc. (Nasdaq: CRTX) announced the results of its Phase I clinical trial to assess the safety and tolerability of an oral single dose of the R(+) isomer of zileuton in healthy subjects. R(+) zileuton combined in equal proportion with its mirror image isomer, S(-) zileuton, comprise racemic zileuton, which is the pharmaceutical ingredient in ZYFLO CR(TM) (zileuton) extended-release tablets... Critical Therapeutics' Press Release -

bioMerieux & University of Sunderland : Collaboration in New Research Significantly Improving the Identification of Pseudomonas aeruginosa

April 3, 2008 . A team of researchers from the University of Sunderland and bioMérieux, a leading company in the field of in vitro diagnostics, have achieved a new step in the fight against Pseudomonas aeruginosa, a bacterium responsible for deadly healthcare-associated infections, which kills tens of thousands of people throughout the world every year .

Researchers at the University of Sunderland’s Pharmacy School, Professor Paul Groundwater and Dr. Roz Anderson, in collaboration with Prof. John Perry of Freeman Hospital in Newcastle, Prof. Arthur James of Northumbria University and Sylvain Orenga of bioMérieux have discovered a new technique for the highly specific detection of Pseudomonas aeruginosa, which primarily infects the lungs of patients with cystic fibrosis. It is also a major cause of infection among patients with immune deficiencies, such as patients with AIDS and cancer or those suffering from burns... bioMérieux's Press Release -

TaiGen : Positive Data From the Phase II Study of Nemonoxacin (TG-873870) in Community-Acquired Pneumonia

2008/04/07 - -TaiGen Biotechnology Co., Ltd. announced today that the nemonoxacin phase II top-line data in community-acquired pneumonia (CAP) met the primary endpoint of non-inferiority versus levofloxacin, the leading quinolone on the market. Nemonoxacin is a novel non-fluorinated quinolone that has a broad spectrum of activity against gram-positive and gram-negative bacteria and atypical pathogens. Importantly, nemonoxacin possesses the first-in-class activity against MRSA (both hospital- and community-acquired) and vancomycin-resistant pathogens... TaiGen Biotechnology's Press Release -

Aeolus Pharmaceuticals : AEOL 10150 Protects Lungs from Fractionated Radiation

April 15, 2008 -Aeolus Pharmaceuticals, Inc. (OTCBB: AOLS) reported data published in the peer-reviewed journal, Free Radical Research, show the Company’s lead compound, AEOL 10150, provided statistically significant protection of the lungs of Fisher 344 rats exposed to fractionated radiation in a study led by Zeljko Vujaskovic, M.D. Ph.D. of Duke University. The study also demonstrated that the compound reduced markers for tissue hypoxia, angiogenesis, inflammation and oxidative stress in rats studied in this experiment.

The primary objective of this study was to determine whether administration of AEOL 10150 reduces the severity of long-term lung injury induced by fractionated radiation.. [PDF] Aeolus Pharmaceuticals' Press Release -

AVEO’s Novel Triple VEGF Receptor Inhibitor... Clinical Activity and Tolerability in other Solid Tumors including Colon and Lung Cancers

April 14, 2008 – AVEO Pharmaceuticals, Inc., a biotechnology company leveraging breakthrough discoveries in cancer biology to discover, develop and commercialize targeted oncology therapies, today announced that their novel oral triple VEGF receptor inhibitor AV-951 shows clinical activity in multiple advanced solid tumor types including renal, colon and lung cancers and is well tolerated according to new data from the expanded Phase 1 clinical trial of the company’s lead product candidate. Partial response or stable disease was observed across all patients with renal cell carcinoma, and overall, one-third of patients across all tumor types achieved tumor shrinkage during treatment with AV-951... AVEO Pharmaceuticals' Press Release -

Idera Pharmaceuticals : Preclinical Data of its Toll-Like Receptor - Targeted Compounds at AACR Meeting

Apr 09, 2008 - Idera Pharmaceuticals, Inc. (Nasdaq: IDRA) announced that preclinical data from its Toll-Like Receptor (TLR) programs will be presented at the 2008 Annual Meeting of the American Association for Cancer Research (AACR) being held in San Diego, CA, April 12-16, 2008...
... Abstract 2078 entitled "Antitumor activity of IMO-2055, an agonist of TLR9, in combination with erlotinib and bevacizumab in non-small cell lung cancer xenografts in mice" will be presented by Idera. In the study, IMO-2055, a TLR9 agonist, was evaluated in combination with erlotinib and bevacizumab in preclinical mice models... Idera Pharmaceuticals' Press Release -

Kamada : New Orphan Drug Designation by the FDA, for its Aerosolized AAT for the treatment of Bronchiectasis

April 8th, 2008 - Kamada, a biopharmaceutical company which develops, manufactures and markets specialty life-saving therapeutics, announces today that the company was granted an Orphan Drug Designation to its Aerosolized Alpha-1 Antitrypsin (AAT) product to treat Bronchiectasis.
Kamada's aerosolized AAT product for treating Bronchiectasis, a lung disease that results in the distortion of one or more of the conducting bronchi or airways, is currently undergoing Phase II clinical trials... Kamada's Press Release -

Yale and Asuragen : a microRNA Can Reduce Lung Cancer Growth

March 25, 2008 - -A microRNA (miRNA) molecule known as let-7 substantially reduced cancer growth in multiple mouse models of lung cancer as reported by researchers at Yale University School of Medicine and Asuragen, Inc. in the journal Cell Cycle.

Cancer afflicts 1.5 million people a year in the United States alone, and lung cancer is the most common and deadly form of cancer worldwide. This study indicates a direct role for a miRNA in cancer progression and introduces a new therapeutic paradigm that features the treatment of cancer with a naturally occurring small RNA... [PDF] Asuragen's Press Release - [PDF] Mirna Therapeutic's Press Release -

Aradigm : Trial of Lung Rx's Inhaled Treprostinil

April 8, 2008--Aradigm Corporation (OTCBB: ARDM) announced it initiated a bridging clinical trial of inhaled treprostinil utilizing its AERx Essence(R) pulmonary delivery system. The trial in healthy volunteers is being conducted in the United Kingdom to evaluate aerosol delivery by assessing lung distribution, pharmacokinetics and safety of inhaled treprostinil delivered by the AERx Essence system versus delivery with the Nebu-Tec OPTINEB*-ir nebulizer.
The latter device was used by Lung Rx, Inc. (Lung Rx), a wholly owned subsidiary of United Therapeutics Corporation, in the recently concluded TRIUMPH (TReprostinil Sodium Inhalation Used in the Management of Pulmonary Arterial Hypertension) study of inhaled treprostinil in patients with Pulmonary Arterial Hypertension (PAH)... Aradigm's Press Release -

KaloBios : Phase 1/2 Trial of Humaneered Monoclonal Antibody KB001 for Treatment of Pseudomonas Infections in Cystic Fibrosis Patients

March 31, 2008 – KaloBios Pharmaceuticals, Inc., a privately held biopharmaceutical company, announced the initiation of a Phase 1/2 clinical trial of KB001, a Humaneered™, high-affinity antibody fragment that KaloBios is developing for the treatment of P. aeruginosa infections. The trial is being conducted in conjunction with the Cystic Fibrosis Foundation and its affiliated organizations.
The blinded, placebo-controlled trial, which is being conducted at over 10 sites across the United States, will enroll up to 48 patients with cystic fibrosis who will receive either one of two dose levels of KB001 or placebo. Endpoints for the trial include safety, reduction of P. aeruginosa bacteria, and inflammatory markers... KaloBios' Press Release -

Kamada : Phase III Clinical Trial with Intravenous AAT

April 02, 2008 - Kamada, a biopharmaceutical company developing, producing and marketing a line of specialty, life-saving therapeutics, announced that it has successfully met the primary endpoint in the Phase III US clinical trials with its intravenous Alpha-1 Antitrypsin (AAT). The product is used to treat hereditary AAT deficiency which leads to Congenital Emphysema... Kamada's Press Release -

Cortex : Enrollment in Opiate Induced Respiratory Depression Clinical Trial in Germany

March 31, 2008 — Cortex Pharmaceuticals, Inc. (AMEX: COR), was notified by the German regulatory agency which approves the use of narcotic drugs that it can proceed with the trial which will use alfentanil, an opiate analgesic. With this approval the enrollment of subjects into the dose response study evaluating the ability of CX717 to prevent respiratory depression caused by opiate analgesics has begun. The study is a placebo controlled, double blinded, cross-over design with three doses of CX717compared to placebo. Depending on the pace of subjects being enrolled, Cortex at this point believes that top-line data will be available from this study by the end of June, 2008... Cortex Pharmaceuticals' Press Release -

Actelion and Nippon Shinyaku : pulmonary arterial hypertension (PAH) compound collaboration

February 29, 2008 - Nippon Shinyaku Co., Ltd. and Actelion Ltd announced today that the two companies have signed a binding letter of intent regarding Nippon Shinyaku's novel PGI 2 receptor agonist NS-304 for the treatment of pulmonary arterial hypertension (PAH) *1).NS-304, originally discovered and synthesized by Nippon Shinyaku, is an orally available long acting prostaglandin I 2 receptor agonist *2) , w hich stim ulates PGI 2 receptor in blood vessels and exerts vasodilating effects. NS-304 has major potential as a novel treatment of PAH. Nippon Shinyaku has recently completed phase I evaluation in the United Kingdom. A phase II program in PAH patients was initiated in Europe at the end of 2007... Nippon Shinyaku's Press Release - Actelion's Press Release -

Angeion : Medical Graphics Platinum Elite Series Plethysmograph for Pulmonary Function Testing

March 17, 2008 ─ Angeion Corporation (NASDAQ: ANGN) introduced the Medical Graphics Platinum Elite™ Series plethysmograph. Based on the award winning Elite Series design, the Platinum Elite offers advanced functionality, ease of operation, precision, reliability and improved patient comfort. Designed for use in hospitals and doctors’ offices, the Platinum Elite is used to measure pulmonary function in the diagnosis of airway diseases such as chronic obstructive pulmoary disease (COPD), asthma, emphysema, allergies and other lung conditions... Angeion's Press Release -

Ceragenix Pharmaceuticals : CeraShield(TM) Coated Endotracheal Tubes Provide up to 21 Days of Protection against Bacterial Colonization in Preclinical

Mar 18, 2008 -- Ceragenix Pharmaceuticals, Inc. (OTCBB:CGXP) (the "Company"), a biopharmaceutical and medical device company focused on infectious disease and dermatology, announced that preclinical testing of the Company's CeraShield(TM) coated endotracheal tubes and C.R. Bard's recently FDA cleared Agento(TM) tube has shown that Cerashield(TM) coated endotracheal tubes were able to provide a 7 fold increase in the duration of antimicrobial protection compared to the recently cleared silver coated Agento(TM) tube from C.R. Bard. The CeraShield(TM) coated endotracheal tube was able prevent bacterial colonization and biofilm development for 21 days while C.R. Bard's Agento(TM) endotracheal tubes lost their ability to prevent bacterial colonization and biofilm development after 3 days when challenged with daily high inocula (10E6) of Pseudomonas aeruginosa. Bacterial growth on endotracheal tubes is a key component in the pathogenesis of Ventilator Associated Pneumonia ("VAP") which afflicts an estimated 250,000 patients each year and is associated with high morbidity ( 36,000 deaths) and added hospital costs of $4 billion in the U.S. alone... Ceragenix's Press Release -

NIR Diagnostics : agreement with a European medical device distributor for HemoNIR

March 17, 2008 - NIR Diagnostics Inc. (TSX Venture: NID), an innovator in the development of handheld healthcare diagnostic devices, announced that it has signed a regional distribution agreement for its portable CO-oximeter device, HemoNIR™, with a European based medical device distributor company. The multi-year agreement stipulates that the Distributor must meet a defined set of sales performance criteria. NIR Diagnostics is currently not disclosing the name of the Distributor pending the completion of negotiations with North American medical device companies also interested in distribution rights to HemoNIR™... NIR Diagnostics' press Release -

Third Wave’s InPlex CF Molecular Test : FDA Clearance

March 14, 2008—Third Wave Technologies Inc. (NASDAQ: TWTI) announced that the company has received clearance from the U.S. Food and Drug Administration of its InPlex™ CF Molecular Test. The test simultaneously detects and identifies cystic fibrosis mutations in patient DNA samples. The InPlex™ CF Molecular Test delivers the accuracy of Third Wave’s Invader® chemistry in an easy-to-use microfluidic card developed in collaboration with 3M Co. In studies submitted to the FDA as part of the company’s clearance application, the InPlex™ CF Molecular Test achieved 100% agreement on cystic-fibrosis positive samples and 99.96% overall agreement when compared to DNA sequencing, the standard for genotype determination... Third Wave Technologies' Press Release -