Transgene's Therapeutic Vaccine TG4010, Phase IIb Data in Advanced Non-Small Cell Lung Cancer

January 10, 2008 - Transgene(Euronext Paris: FR0005175080) announces promising preliminary data from the Phase IIb trial evaluating its therapeutic vaccine TG4010 (MVA-MUC1-IL2) as an adjunct to first line chemotherapy in patients with advanced non-small cell lung cancer (NSCLC)... [PDF] Transgene's Press Release-

Agennix, Pivotal Trial of Talactoferrin Alfa in First-Line Non-Small Cell Lung Cancer,

January 17, 2008 — Agennix Incorporated announced that the U.S. Food and Drug Administration (FDA) has approved the design of a single, pivotal, Phase 3 trial evaluating its lead molecule, talactoferrin alfa, in combination with chemotherapy as first-line treatment in patients with non-small cell lung cancer (NSCLC) under the Special Protocol Assessment (SPA) process. Separately, Agennix received Scientific Advice from the European Medicines Agency (EMEA) indicating that this single trial will also support a Marketing Authorization Application (MAA) in the European Union. Agennix had previously received Fast Track designation from the FDA for this indication... Agennix' Press Release-

Peregrine Pharmaceuticals, Approval to Conduct a Phase II Trial of Bavituximab in Patients With Non-Small Cell Lung Cancer

Jan 22, 2008 - Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), a clinical stage biopharmaceutical company developing monoclonal antibodies for the treatment of cancer and hepatitis C virus (HCV) infection, announced that its Phase II clinical protocol to study bavituximab in combination with chemotherapy in patients with non-small cell lung cancer (NSCLC) has been approved by the Drug Controller General of India (DCGI). The primary objective of the multi-center clinical trial is to assess the overall tumor response rate in NSCLC patients treated with the combination of bavituximab and carboplatin plus paclitaxel... Peregrine's Press Release-

Vapotherm, Patent For Apparatus And Method For Respiratory Tract Therapy

1/22/2008 – Vapotherm, the global leader in High Flow Oxygen Therapy products, announced today that U.S. patent rights have been validated for an apparatus used in the delivery tube technology for respiratory tract therapy. Reinforcing Vapotherm’s principal role in the industry, the U.S. Patent No. 7,314,046 B2 has been granted through 2022 and provides Vapotherm the right to prevent or exclude other companies from making, using, selling, or offering to sell or import the invention.

The triple lumen design is the vital component for Vapotherm products as it helps deliver humidified air to the respiratory tract of patients. Used throughout all Vapotherm products, including the 2000i and the recently introduced Precision Flow™, the apparatus allows Vapotherm to maintain the conditioned breathing gases to the patient and thus aid with respiratory tract therapy and treatment... Vapotherm's Press Release-

Serenex, to Evaluate Proprietary Small Molecule Hsp90 Inhibitors as a Potential Treatment for Lung Cancer

January 24, 2008 - Serenex, Inc., a leader in the discovery and development of small molecule Heat Shock Protein 90 (Hsp90) inhibitors, announced the signing of a Materials Cooperative Research and Development Agreement (M-CRADA) with the National Cancer Institute (NCI) at the National Institutes of Health (NIH). Under this M-CRADA, Dr. Leonard Neckers and his colleagues at the NCI will assess Serenex's novel, small molecule, orally bioavailable Hsp90 inhibitor SNX-5422 as a potential therapeutic for non-small cell lung cancer... [PDF] Serenex' Press Release-

Kamada, Phase I Studies with Aerosolized AAT for the Treatment of Lung Diseases

January 15, 2008 - Kamada (TASE: KMDA), a biopharmaceutical company developing, producing and marketing specialty life-saving therapeutics, has successfully concluded Phase I clinical studies designed to test the safety and tolerability of the aerosolized version of its flagship product, Alpha-1 Antitrypsin (AAT) using an optimized eFlow Electronic Nebulizer (PARI Pharma GmbH) to treat various lung diseases... Kamada's Press Release - PARI 's Press Release-

20/20 GeneSystems, Licenses Lung Cancer Blood Test to Ortho-Clinical Diagnostics

January 17 , 2008 - 20/20 GeneSystems, Inc. (“20/20”), a developer of innovative diagnostic products for early disease detection and personalized medicine, announced that it has entered into an agreement with Raritan, N.J., based Ortho-Clinical Diagnostics (“OCD”) to license certain 20/20 intellectual property relating to a blood test for the early detection of lung cancer(...) 20/20 and its collaborators from the University of Kentucky have published study results that showed that its multi-biomarker blood test may be able to detect non-small cell lung cancer (NSCLC) significantly earlier and with better accuracy than CT scans, the most advanced technique in current use for detecting this disease...20/20 GeneSystems' Press Release-

PhytoMedical, Patented Anti-Cancer Compounds Kill Lung Cancer Cells

January 22, 2008 - PhytoMedical Technologies, Inc. (OTCBB: PYTO) (FWB: ET6) announced that its patented bis-intercalator anti-cancer compound achieved a 50% or greater cancer cell kill rate in new in vitro studies of the DMS 114 strain of human small lung cancer cells, an important outcome given lung cancer’s high mortality rate and the lack of effective treatment options(...)Among several bis-intercalator anti-cancer compounds tested in vitro against the DMS 114 strain of human small lung cancer cells, researchers identified a high performance compound which required the least concentration in order to achieve a 50% or greater cancer cell kill rate. This strong activity against human small lung cancer cells is a significant achievement given that lung cancer kills more Americans annually than any other type of cancer, according to the National Cancer Institute... PhytoMedical's Press Release-

Pharmaxis, Aridol, first Asian Approval

Jan. 16, 2008 — Pharmaxis (ASX: PXS; Nasdaq: PXSL) announced the Korean regulatory agency has granted marketing approval for its asthma management product, Aridol... [PDF] Pharmaxis' Press Release-

Nycomed, ALVESCO , FDA approval for the U.S. market

15.01.2008 - Nycomed announced today that the Food and Drug Administration (FDA) approved ALVESCO (ciclesonide) Inhalation Aerosol in the United States for the maintenance treatment of asthma and as prophylactic therapy in adult and adolescent patients aged 12 years and older. ALVESCO is an inhaled corticosteroid with novel release and distribution properties...
...ALVESCO is based on the active ingredient ciclesonide which is Nycomed’s patented corticosteroid with a novel principle of action. Ciclesonide is a prodrug that is activated by intracellular esterases following oral inhalation. ALVESCO has wide inhibitory activities against multiple inflammatory cell types and chemicals involved in the asthmatic response... Nycomed's Press Release-

Aeras and Crucell, Start of a Tuberculosis Vaccine Clinical Trial

December 21, 2007 - Dutch biotechnology company Crucell N.V. (Euronext, NASDAQ: CRXL; Swiss Exchange: CRX) announced it will receive up to USD 5 million from Rockville, Maryland-headquartered Aeras Global TB Vaccine Foundation to support the advanced development of the candidate AdVac- and PER.C6-based tuberculosis vaccine...
Crucell and Aeras also announced the launch of a new Phase I BCG-Ad35 prime boost clinical trial of the unique AdVac-based tuberculosis vaccine, weeks sooner than expected...
Aeras and Crucell began jointly developing this vaccine candidate, called AERAS-402, in 2004 using Crucell's AdVac vaccine technology and PER.C6 manufacturing technology... Crucell's Press Release-

Exelixis, Phase 1/2 Trial of XL184 in Patients With Non-Small Cell Lung Cancer

Jan 07, 2008 - Exelixis, Inc. (Nasdaq: EXEL) announced that it has initiated a phase 1/2 trial of XL184 in patients with non-small cell lung cancer (NSCLC) who have had progressive disease while on a regimen containing erlotinib.XL184 is a small molecule that simultaneously inhibits the MET, RET and VEGFR receptor tyrosine kinases. In the initial phase 1 part of the study, safety and pharmacokinetics of combining XL184 with erlotinib will be evaluated. The primary endpoint of the phase 2 part of the study is overall response rate. Secondary endpoints include progression-free survival, overall survival and pharmacodynamics... Exelixis' Press Release-

Genzyme, License Agreement with Moffitt Cancer Center for Exclusive Rights to Lung Cancer Diagnostic

January 15, 2008 - Genzyme Corp. (Nasdaq: GENZ) announced that it has entered into a license agreement with Moffitt Cancer Center to obtain exclusive worldwide diagnostic testing rights to the discovery of the relationship of two proteins to patient response to non-small cell lung cancer (NSCLC) treatment...The expression levels of the two proteins, RRM1 and ERCC1, have been shown by Dr. Gerold Bepler, M.D., and his team from Moffitt, to correlate with patient response to platinum drugs and gemcitabine, both of which are commonly used in treating NSCLC... Genzyme's press Release-

Luminex , FDA Clearance for xTAG Respiratory Viral Panel

Jan. 3, 2008 -Luminex Corporation (NASDAQ: LMNX), the worldwide leader in multiplexed solutions, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its xTAG(TM) Respiratory Viral Panel (RVP). xTAG RVP is the first FDA-cleared assay to simultaneously detect and identify 12 viruses and viral subtypes that together are responsible for more than 85 percent of respiratory viral infections... Luminex' Press Release -

GlaxoSmithKline and Theravance, 642444 and 685698 advance in clinical development for the treatment of asthma

Jan. 03, 2008 - GlaxoSmithKline Plc (GSK) and Theravance, Inc. (NASDAQ: THRX) announced the start of large Phase 2b asthma dose-optimisation studies with both the lead inhaled corticosteroid (ICS) GW685698 ('698) and the lead long-acting beta agonist (LABA) GW642444 ('444) assets in the 'Horizon' programme to develop a next-generation combination product. GSK began enrolling patients with mild to severe asthma in the '698 Phase 2b clinical programme on 21st December 2007 and began enrolling patients with persistent asthma in the '444 Phase 2b clinical programme on 29th December 2007. These clinical programmes will determine the most effective doses to be taken into Phase 3 combination studies. The Phase 2b COPD programme with '444 is also on schedule to commence in 1H 2008... GSK's Press Release - Theravance's Press Release-

Alnylam, Progress in Clinical Development of ALN-RSV01 for the Treatment of Respiratory Syncytial Virus (RSV) Infection

Dec. 13, 2007 -Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced the presentation of results from its Phase I trial with ALN-RSV01 delivered via inhalation at the 18th Annual Drug Delivery to the Lungs meeting being held in Edinburgh, U.K. These data represent an important milestone in the company's efforts to advance ALN-RSV01 as an anti-viral drug for the treatment of RSV infection in patients. The Phase I study represents the first-ever clinical study of an RNAi therapeutic administered via inhalation... Alnylam's Press Release -