Delphi Medical Systems : New Delphi Portable Oxygen Concentrator Designed to Provide Exceptional Portability to Patients

May 6, 2008 - Delphi Medical Systems, a subsidiary of Delphi Corp., is introducing its new portable oxygen concentrator, the Central Air, which can help patients gain increased freedom and independence by providing exceptional durability in a lightweight package. Delphi also announced that it has entered an exclusive agreement with evo Medical Solutions to distribute the device in North America for millions of adults who require supplemental oxygen treatment after being diagnosed with chronic obstructive pulmonary disease (COPD). Currently, the device has 510(k) clearance from the U.S. Food and Drug Administration (FDA).

Delphi's design delivers concentrated oxygen in a compact size and convenient format, and boasts the smallest footprint and package size in its class. Measuring under a foot high and weighing less than 10 pounds, the unit allows premium portability so that patients can participate in more mobile lifestyles... Delphi Medical Systems' Press Release -

ImClone : Significant Data on ERBITUX (cetuximab) and ImClone Pipeline to Be Presented at American Society of Clinical Oncology 2008 Annual Meeting

May 16, 2008 - ImClone Systems Incorporated (NASDAQ: IMCL), a global leader in the development and commercialization of novel antibodies to treat cancer, today announced that significant scientific data on ERBITUX(R) (cetuximab) will be presented at the American Society of Clinical Oncology (ASCO) 2008 Annual Meeting taking place May 30 through June 3, 2008 in Chicago...
...

Non-Small Cell Lung Cancer

• A phase II study of cetuximab (C225) in combination with chemoradiation (CRT) in patients (PTS) with stage III A/B NSCLC: A report of the 2-year and median survival (MS) for the RTOG 0324 trial. G.R. Blumenschein (#7516)
• A phase II study of pemetrexed, carboplatin and thoracic radiation with or without cetuximab in patients with locally advanced unresectable non-small cell lung cancer: CALGB 30407 - - Early evaluation of feasibility and toxicity. R. Govindan (#7518)... ImClone Systems' Press Release -
  

Olympus Medical Systems and Spiration : Agreement to Market and Distribute Minimally Invasive Pulmonary Device in 43 European Countries

May 19, 2008 – Olympus Medical Systems Corp. and Spiration, Inc. announced today that the companies have signed a definitive agreement granting Olympus exclusive marketing and distribution rights in Europe for Spiration's IBV® Valve System. Olympus will launch the product in select European countries from Autumn 2008. The IBV Valve System is a minimally invasive treatment that has diverse applications for both acute and chronic conditions of the lung.

In Europe, the system has received market clearance through CE Mark for diseased and damaged lung, a broad indication that includes the treatment of emphysema and the resolution of prolonged air leaks, a complication that can occur following lung surgery... Olympus Medical Systems' Press Release - [PDF] Spiration's Press Release -

Pfizer : New Data in Lung Cancer to Be Presented at ASCO

May 16, 2008 - Pfizer announced that study results across several difficult-to-treat cancers will be presented at the 44^th American Society of Clinical Oncology (ASCO) annual meeting in Chicago from May 30 to June 3, 2008. Pfizer will hold two briefings for journalists on June 1 and investors on June 2.

Researchers will present the latest data from the breadth of Pfizer’s oncology portfolio, focused in four areas of discovery: anti-angiogenesis, signal transduction, immuno-oncology and cytotoxics/potentiators...

...Non-small Cell Lung Cancer (NSCLC)

• Phase 2 data evaluating the activity of the anti-IGF-1R antibody CP-751,871 in combination with paclitaxel and carboplatin in NSCLC will be presented by Dr. Daniel Karp, MD Anderson Cancer Center on Monday, June 2.
• Phase 1 clinical trial data exploring the safety and preliminary activity of PF-299804, an irreversible pan-HER inhibitor will be presented by Dr. Pasi A. Janne, Dana Farber Cancer Center on Monday, June 2.
• Characterization of NSCLC patients responding to anti-IGF-1R therapy will be presented by Dr. Antonio Gualberto, Pfizer Global Research and Development on Sunday, June 1... Pfizer's Press Release -
  

Array BioPharma and AstraZeneca : New Phase 2 Development Plans for the Investigational Anti-Cancer Drug AZD6244 (ARRY-886)

May 15, 2008 - Array BioPharma Inc. (NASDAQ: ARRY) and AstraZeneca (NYSE: AZN) announced plans for two additional randomized Phase 2 trials for AZD6244 (ARRY-886). The trials, which will begin during the second half of 2008, will test AZD6244 in combination with a cytotoxic chemotherapeutic agent; one trial will be in melanoma patients and the other in non small cell lung cancer patients. These plans are based upon AZD6244's activity as a single agent in previous monotherapy Phase 2 trials and on data from multiple preclinical studies.
The data from these earlier clinical trials will be presented at the forthcoming American Society of Clinical Oncology Annual Meeting... Array BioPharma's Press Release -

Guided Therapeutics, Inc. and Konica Minolta : to Expand Cancer Detection Technology

May 06, 2008 - Guided Therapeutics, Inc. (GT) (Pink Sheets: SPRX) announced that it has entered into a collaborative option to license and no shop agreement with Konica Minolta Opto, Inc. (KMOT) of Tokyo.
Under terms of the agreement, KMOT will have a defined period of time to evaluate certain applications of GT’s technology, including the potential adaptation of its LightTouch™ non-invasive cervical cancer detection technology to lung and biliary cancer.
KMOT also will purchase prototype equipment and single use disposables... [PDF] Guided Therapeutics' Press Release -

Arriva Pharmaceuticals Granted Fusion Protein Patent

May 21, 2008 - Intellectual Property Provides Strong Position for Development of Therapy for Asthma- Arriva Pharmaceuticals, a biopharmaceutical company focused on developing anti-inflammatory therapies, announced today that it had been granted a patent in the U.S. related to a fusion protein with potential applications for treating respiratory diseases. The patent (United States Patent 7,247,704) covers compositions of matter and uses of Aeriva™, a fusion protein that combines Secretory Leukocyte Protease Inhibitor (SLPI) and recombinant alpha 1-antitrypsin (rAAT)... [PDF] Arriva Pharmaceuticals' Press Release -

EPIX Pharmaceuticals : Phase 2a Data at American Thoracic Society Meeting

May 15, 2008 - EPIX Pharmaceuticals, Inc. (NASDAQ:EPIX), a biopharmaceutical company focused on discovering and developing novel therapeutics through the use of its proprietary and highly efficient in silico drug discovery platform, announced that Michael G. Kauffman, M.D., Ph.D., chief executive officer of EPIX, is scheduled to present an oral presentation entitled "Selective Serotonin-2B Receptor Antagonist PRX-08066 Improves Pulmonary Hypertension Associated with Chronic Obstructive Pulmonary Disease" at the International Conference of the American Thoracic Society in Toronto on Wednesday, May 21, 2008 at 2:50 p.m. ET.

EPIX previously announced the results of a Phase 2a clinical trial of PRX-08066 in patients with pulmonary hypertension (PH) associated with chronic obstructive pulmonary disease (COPD)... EPIX Pharmaceuticals' Press Release -

Osiris Therapeutics : Phase II Clinical Trial Evaluating Prochymal for Chronic Obstructive Pulmonary Disease

May 21, 2008 - Osiris Therapeutics, Inc. (NASDAQ:OSIR) announced the treatment of the first patients in a new Phase II clinical trial evaluating Prochymal, a mesenchymal stem cell (MSC) therapy, for moderate to severe Chronic Obstructive Pulmonary Disease (COPD). This trial marks the sixth indication for which Prochymal has been advanced into Phase II or later-stage clinical trials.

COPD, a form of lung disease characterized by limitation or obstruction of airflow in the airway, encompasses both emphysema and chronic bronchitis. COPD is the fourth leading cause of death in the U.S. with an estimated 12 million Americans diagnosed with the disease. COPD has no known cure, thus current therapeutic intervention is aimed at providing relief of symptoms. Preclinical and clinical data suggest that Prochymal’s unique mechanism of action may provide a first-in-class treatment option with the ability to reverse the underlying disease... [PDF] Osiris Therapeutics' Press Release -

3M : First FDA-Cleared Respirators for General Public Use in Public Health Medical Emergencies Now Available

May 16, 2008 - -Consumers concerned about an influenza outbreak can breathe a little easier: 3M has just released two new NIOSH N95 respirators for use by the general public in public health medical emergencies.
These two respirators—3M™ Particulate Respirator 8612F and 3M™ Particulate Respirator 8670F—are unique because they are the first to receive clearance by the U.S. Food & Drug Administration (FDA) to reduce exposure to airborne germs during a public health medical emergency such as an influenza pandemic. The FDA outlined a special clearance process for N95 respirators used by the general public in public health medical emergencies in order to provide reasonable assurance of their safety and effectiveness... 3M's Press Release -

VGX Pharmaceuticals : multi-year production agreement with the United Kingdom Cystic Fibrosis Gene Therapy Consortium

May 12, 2008 – VGX Pharmaceuticals (VGX) announced that the Company has signed a multi-year supply agreement to provide plasmid DNA to support the ongoing toxicology and clinical trials of the United Kingdom Cystic Fibrosis Gene Therapy Consortium comprising over 80 scientists and clinicians in Edinburgh, London and Oxford dedicated to the search for effective gene therapy to the lungs of those with Cystic Fibrosis. Under the terms of the agreement, VGX will provide multiple batches of a CFTR product to support clinical studies planned to run through 2010. If all options are exercised, several hundred grams of plasmid DNA will be provided, making this agreement one of the largest contracts for non-viral gene therapy products ever undertaken... VGX Pharmaceuticals' Press Release -

Nektar : Patent Covering Pulmonary Targeted Antibiotics

May 7, 2008 - Nektar Therapeutics (Nasdaq: NKTR) announced that the U.S. Patent and Trademark Office has issued Patent No. 7,368,102, which covers compositions and methods for creating and delivering Tobramycin Inhalation Powder (TIP) and other aminoglycoside antibiotics delivered via Nektar's proprietary Dry Powder Inhaled Technology. This patent extends through the year 2022.

TIP is being co-developed by Nektar and Novartis and is currently in Phase 3 development for the prevention and treatment of Pseudomonas aeruginosa pneumonia. Cystic fibrosis patients are susceptible to chronic infection by P. aeruginosa, which is responsible for high rates of illness and death in this patient population. Nektar's Dry Powder Inhaled Technology has the capability to administer high local lung concentrations of TIP that may provide significant benefits to patients suffering from this debilitating disease... Nektar Therapeutics' Press Release -

Oscient & Menarini : Regulatory Filing for FACTIVE Tablets Submitted in Europe

May 7, 2008 - Oscient Pharmaceuticals Corporation's (Nasdaq: OSCI) commercialization partner for FACTIVE(R) (gemifloxacin mesylate) tablets, Menarini Group, a leading European pharmaceutical company based in Italy, has submitted a regulatory filing seeking approval of FACTIVE in Europe. Menarini, with broad sales and marketing coverage throughout Europe and expertise in research and clinical development, has the fourth largest pharmaceutical sales force in Europe and is second largest in terms of calls to primary care physicians...

... Menarini is seeking approval of FACTIVE for the treatment of community-acquired pneumonia, acute bacterial exacerbations of chronic bronchitis and acute bacterial sinusitis. The regulatory review time in Europe is approximately 12 months.... Oscient Pharmaceuticals' Press Release -

GE HEALTHCARE & Merck : GLOBAL MOLECULAR DIAGNOSTIC AGREEMENT TO ADVANCE RESPIRATORY DRUG DEVELOPMENT

May 05, 2008 - - GE Healthcare, a subsidiary of the General Electric Company (NYSE:GE) announced today that it has signed a non-exclusive agreement with Merck & Co., Inc. to share technology on imaging of the lungs that may help to advance respiratory treatment development.

Under terms of the agreement, Merck will be granted access to Spin Signal TechnologyTM (SST) utilizing hyperpolarized Xenon 129 gas, a molecular imaging agent that is under investigation by GE Healthcare to provide high speed, quantitative imaging of the lung using Magnetic Resonance Imaging (MRI). GE Healthcare originally licensed this technology from Princeton University... GE Healthcare's Press Release -

Sepracor & Arrow : Global License and Development Agreement Covering Technology to Enhance Ciclesonide and BROVANA Franchises

May 1, 2008- Sepracor Inc. (Nasdaq: SEPR) announced it has signed a technology license and development agreement with Arrow International Limited (Arrow), a European company, for know-how and intellectual property rights related to stable sterile steroid suspension formulations as well as other applicable nebule technology for the use in developing ciclesonide, a corticosteroid, in an inhalation solution. The agreement facilitates enhanced development of Sepracor's ciclesonide stand-alone product for the treatment of asthma as well as a planned ciclesonide/ BROVANA(R) brand arformoterol tartrate Inhalation Solution combination product for the treatment of COPD, and includes Arrow's "U-Bend" packaging technology, which allows increased accuracy in dosing through a novel U-Bend ampule design... Sepracor's Press Release -

Critical Therapeutics : Definitive Agreement to Merge with Cornerstone BioPharma

May 01, 2008 - Critical Therapeutics, Inc. (NASDAQ: CRTX) and Cornerstone BioPharma Holdings, Inc., a privately-held company, announced the signing of a definitive merger agreement.
Cornerstone is a specialty pharmaceutical company focused on developing and commercializing prescription medications for respiratory disorders... Critical Therapeutics' Press Release - Cornerstone BioPharma's Press Release -

KaloBios : Patient Dosing in its U.S. Phase 1 Trial of Its Third Drug Candidate, KB003

April 28, 2008 – KaloBios Pharmaceuticals, Inc., a privately held biopharmaceutical company, today announced that the company has completed dosing subjects in a U.S. Phase 1 clinical trial of its third drug candidate, KB003. The study is a placebo-controlled, single-dose, dose-escalation Phase 1 trial in healthy volunteers, with safety and immunogenicity as primary endpoints.
KB003 is a Humaneered™ monoclonal antibody targeted to GM-CSF, and it shares the same epitope (target) and pharmacokinetic properties with KB002, its chimeric (mouse) precursor. They are part of a major development program that collectively includes five Phase 1 and Phase 2 proof-of-principle clinical trials for inflammation-related diseases, including persistent asthma and rheumatoid arthritis. Animal studies have suggested the drug candidate also has potential in multiple sclerosis, chronic obstructive pulmonary disease (“COPD”), psoriasis, and other indications... KaloBios Pharmaceuticals' Press Release -

Compugen : Discovery of Blood Based Biomarker for Diagnosis of Lung Cancer

April 29 2008 – Compugen Ltd. (NASDAQ: CGEN) announced the discovery and experimental verification of CGEN-438, a potential blood based biomarker for lung cancer. CGEN-438 is novel splice variant peptide of delta-like protein 3 precursor (DLL3). Importantly, the Compugen discovered biomarker is a peptide that is secreted from the cell into the bloodstream, whereas the previously known DLL3 is a protein located on the cell membrane. Initial clinical evidence indicates that the Compugen discovered molecule could potentially serve as both a serum biomarker for the diagnosis of small cell lung cancer and as a component in a biomarker combination for the diagnosis of non-small cell lung cancer patients... Compugen's Press Release -

Nabi Biopharmaceuticals Prevails in Opposition Hearing for NicVAX Patent

April 30, 2008 - Nabi Biopharmaceuticals (Nasdaq:NABI) announced today that the European Patent Office (EPO) upheld the Company's European Patent No. EP 1,135,166 (Hapten Carrier Conjugates for Treating and Preventing Nicotine Addiction) that covers its NicVAX(r) vaccine. The EPO issued this patent to Nabi in late 2004 with an expiration date of January 12, 2019... Nabi Biopharmaceuticals' Press Release -

Gilead : Letairis (ambrisentan) Phase IV Program

May 1, 2008 - Gilead Sciences, Inc. (Nasdaq:GILD) announced the initiation of ATHENA-1, a Phase IV, randomized, double-blind, placebo-controlled study evaluating Letairis(R) (ambrisentan 5 mg and 10 mg tablets) in patients with pulmonary arterial hypertension (PAH) demonstrating a sub-optimal response to sildenafil monotherapy. ATHENA-1 is the first of several Phase IV Letairis studies Gilead plans to initiate in 2008 and 2009. Letairis is currently approved as a once-daily treatment for PAH (WHO Group 1) in patients with WHO functional class II or III symptoms to improve exercise capacity and delay clinical worsening... Gilead Sciences' Press Release -

Targacept : Designation of Lead Compound in Smoking Cessation Program, Milestone Payment from GlaxoSmithKline

May 05, 2008 - Targacept, Inc. (NASDAQ:TRGT), a clinical-stage biopharmaceutical company developing a new class of drugs known as NNR Therapeutics (TM), announced the designation of a lead compound in its smoking cessation program, triggering a $500,000 milestone payment under its alliance agreement with GlaxoSmithKline (GSK)...
... Neuronal nicotinic receptors (NNRs) are a class of proteins in the nervous system that modulate the levels of key chemical messengers, such as dopamine. Nicotine’s addictive effects have been linked to over-stimulation of dopamine release in brain regions involved in feelings of reward and pleasure. Various NNR subtypes modulate dopamine release in these pathways and represent optimal targets for therapeutic intervention. Compounds that can normalize the activity of these NNR subtypes have the potential to decrease the rewarding effects of nicotine and, as a result, the desire to smoke... Targacept's Press Release -

GenVec : Grant for RSV Vaccine Program

May 7, 2008 - GenVec, Inc. (Nasdaq:GNVC) announced today that it has received an Advanced Technology Phase I Small Business Innovation and Research (SBIR) grant from the National Institute of Allergy and Infectious Diseases, of the National Institutes of Health, to support the Company’s efforts to develop vaccines for the prevention of respiratory syncytial virus (RSV). The SBIR grant, valued at $600,000 over two years, will support work being conducted exclusively at GenVec... GenVec's Press Release -

Pipex Pharmaceuticals : FDA Orphan Drug Designation For Oral TTM For Idiopathic Pulmonary Fibrosis (IPF)

May 12, 2008 -- Pipex Pharmaceuticals, Inc. (AMEX: PP), a specialty pharmaceutical company developing innovative late-stage drug candidates for the treatment of neurologic and autoimmune diseases, announced that it has received an Orphan Drug designation for oral tetrathiomolybdate (oral TTM) from the FDA for the treatment of Idiopathic Pulmonary Fibrosis (IPF), a deadly pulmonary disease with no FDA-approved therapy.

IPF is a fatal respiratory disease characterized by progressive loss of lung function due to extensive fibrosis of lung tissues that are essential for respiration and life. According to the Coalition for Pulmonary Fibrosis, IPF affects an estimated 128,000 patients in the US, including 48,000 new patients per year, and results in approximately 30,000 deaths in the US annually, more than the number of US deaths annually from either breast or prostate cancer. Currently, there are no FDA-approved therapies for IPF. The standard of care for IPF patients is high-dose corticosteroids and immunosuppressants, which have numerous side effects that increase patient morbidity... Pipex's Press Release -

Pfizer Japan : Champix the First Prescription Oral Smoking Cessation Aid in Japan

April 22, 2008 - Pfizer Inc announced that on May 8, 2008, it will launch Champix® Tablet 0.5mg/1mg (varenicline tartrate), a novel smoking cessation aid for smokers with nicotine dependence in Japan, which has one of the highest rates of smoking among developed nations.

Champix was developed as the first non-nicotine drug designed for smoking cessation in the United States and will be the first oral smoking cessation aid available in Japan. The currently available smoking cessation aids such as ‘Nicotine Replacement Therapy’ (NRT) relieve withdrawal symptoms associated with smoking cessation by replacing tobacco use through delivering nicotine. In contrast, Champix brings about a smoking cessation effect through a new mechanism of action which works by selectively targeting the α4β2 nicotine receptors in the brain to reduce both craving and withdrawal symptoms and reduce the pleasure associated with smoking... Pfizer's Press Release -

Masimo : new Rad-87 Pulse CO-Oximeter, Patient SafetyNet, and noninvasive hemoglobin

May 6, 2008 - Masimo, the inventor of Pulse CO-Oximetry and Measure-Through-Motion-and-Low-Perfusion Pulse Oximetry, will showcase the latest technology for patient safety solutions at the American Association of Critical Care Nurses (AACN), National Teaching Institute (NTI) & Critical Care Exposition in Chicago on May 6-8, 2008. Live demonstrations of the new Masimo Rad-87 Pulse CO-Oximeter™, Masimo Patient SafetyNet™ and continuous, noninvasive hemoglobin (SpHb™) (pending FDA clearance) will show how Masimo technologies can help critical care clinicians advance patient safety, improve patient outcomes, and increase clinical efficiencies... Masimo's Press Release -

Discovery Labs : Approvable Letter from FDA for Surfaxin for RDS

May 2, 2008 - Discovery Laboratories, Inc. (Nasdaq:DSCO) today announced that it has received an Approvable Letter from the U.S. Food and Drug Administration (FDA) for Surfaxin(r) (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants. This official notification sets forth the remaining conditions that must be satisfied to gain U.S. marketing approval for Surfaxin... [PDF] Discovery Labs' Press Release -

PARI : eFlow delivers Alnylam RNAi Therapeutic in Phase II study

APRIL 17, 2008 – An optimized PARI eFlow platform nebulizer will be delivering Alnylam’s ALN-RSV01 in a Phase II human clinical trial that has begun enrolling patients. ALN-RSV01 is a RNAi therapeutic being developed as a treatment for respiratory syncytial virus (RSV) infection, the leading cause of pediatric hospitalization in the U.S. and a prevalent infection in immune-compromised adults. RSV currently does not have a viable treatment option.

“The progression into Phase II clinical trials with Alnylam’s therapeutic is significant as it is the first RNAi program in clinical trials using inhalation... PARI Pharma's Press Release -

Monogram Biosciences : HER1 and HER3 VeraTag™ Assays are Now Available for Use in Development and Clinical Evaluation of Cancer Therapeutics

May 1, 2008 - Monogram Biosciences, Inc. (Nasdaq: MGRM) announced that the company's HER1 and HER3 Quantitative Protein Assays are now available for clinical development use. Built on Monogram's VeraTag^™ platform, the HER1 and HER3 assays provide unique, quantitative measurements of protein expression and activity in formalin fixed paraffin embedded (FFPE) tumor samples. These assays supplement HERmark^™, Monogram's HER2 and HER2:HER2 Homodimer Breast Cancer Assay, and expands the potential clinical reach of Monogram's VeraTag assays to lung, colorectal and other cancers... Monogram Biosciences' Press Release -

MedImmune : Phase 3 Data Regarding Anti-RSV Antibody To Be Presented at Pediatric Academic Societies (PAS) Annual Meeting

May 4, 2008 - MedImmune announced that researchers are currently presenting results from a MedImmune-sponsored Phase 3 study involving motavizumab, an investigational monoclonal antibody (MAb) that is being evaluated for its potential to prevent serious disease caused by respiratory syncytial virus (RSV) in high-risk pediatric patients. Kate O'Brien, M.D., M.P.H., associate professor at the Center for American Indian Health, Johns Hopkins Bloomberg School of Public Health, is the study's principal investigator. Aruna Chandran, M.D., M.P.H., a trial co-investigator, presents the data today at the Pediatric Academic Societies (PAS) Annual Meeting in Honolulu, HI... MedImmune's Press release -

United Therapeutics : Treprostinil Data Presented at Annual Meeting of the American Thoracic Society

May 6, 2008 - United Therapeutics Corporation (Nasdaq: UTHR) and its wholly-owned subsidiary Lung Rx, Inc. announced that data related to the four different routes of administration of the drug, treprostinil, for the treatment of pulmonary arterial hypertension will be presented at the annual meeting of the American Thoracic Society (ATS), to be held in Toronto, Ontario, beginning May 16th and ending May 21, 2008,
including the first public presentation of the full data set from the TRIUMPH-1 study of inhaled treprostinil... United Therapeutics Corporation's Press Release -

Oncothyreon's PX-12 and PX-866 Data presented at AACR Annual Meeting

Apr 16, 2008 - Oncothyreon Inc. (Nasdaq: ONTY) (TSX:ONY) announced that data from pharmacokinetic studies of PX-12 and preclinical studies of PX-866 were presented at the Annual Meeting of the American Association for Cancer Research (AACR) in San Diego, held April 12-16, 2008. Information from the studies may guide future clinical development plans for these product candidates. Oncothyreon is currently conducting a Phase 2 trial of PX-12 in patients with advanced pancreatic cancer and PX-866 is expected to enter a Phase 1 trial in patients with advanced cancers in the second quarter of 2008... Oncothyreon's Press Release -

GlaxoSmithKline : further progress of oncology portfolio

22 April 2008 - GlaxoSmithKline Oncology will present a wide range of new data at the annual American Society of Clinical Oncology (ASCO) meeting in Chicago starting Friday, May 30^th...
...
Non-Small Cell Lung Cancer : Preoperative treatment with pazopanib (GW786034) a multikinase angiogenesis inhibitor in early stage non-small cell lung cancer (NSCLC): a proof-of-concept phase II study...
Small Cell Lung Cancer : Topotecan/cisplatin (TP) compared to cisplatin/etoposide (PE) for patients with extensive disease - small cell lung cancer (ED-SCLC): final results of a randomised phase III trial... GlaxoSmithKline's Press release -

AstraZeneca : Marketing Application in Europe for EGFR Inhibitor Gefitinib (IRESSA™) in Locally Advanced Pre-Treated Non-Small Cell Lung Cancer

2 May 2008 - AstraZeneca announced the submission of a marketing authorisation application to the European Medicines Agency (EMEA) for its oral anti-cancer drug, gefitinib (IRESSA™) as a treatment for locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) in patients who have been pre-treated with platinum-containing chemotherapy.
The application is based on data from the Phase III INTEREST study, which showed that patients with pre-treated advanced NSCLC who received gefitinib had non-inferior overall survival to those treated with intravenous chemotherapy (docetaxel). In addition, gefitinib had a more favourable tolerability profile than docetaxel and significantly more patients receiving gefitinib had an improvement in quality of life... AstraZeneca's Press Release -

Proteolix : Phase 2 Clinical Trial of Carfilzomib in Patients with

May 1, 2008 – Proteolix, Inc. announced that patient dosing has commenced in a Phase 2 clinical trial of carfilzomib (PR-171), a selective blocker of proteasome activity, in relapsed solid tumors. A Phase 1b dose-escalation trial of carfilzomib in patients with advanced solid tumors has recently been completed. The Phase 2 trial will evaluate the safety and efficacy of single-agent carfilzomib in patients with recurrent or advanced solid tumors. Subjects will be enrolled and stratified according to disease type, including non-small cell lung cancer, small cell lung cancer, ovarian cancer and renal cancer. The open-label, multi-center clinical trial is a two-stage design, with pre-determined criteria for continuation after an initial cohort of patients have been treated. Patients enrolled in the study will receive carfilzomib twice a week for three weeks with a one week rest period... Proteolix's Press release -

Poniard Pharmaceuticals : Final Picoplatin Data from Phase 2 Small Cell Lung Cancer Trial Demonstrating Survival Benefit

April 23, 2008 - Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused on oncology, announced that final efficacy results from its Phase 2 clinical trial of picoplatin confirming previously announced interim results showing a survival benefit in patients with recurrent small cell lung cancer (SCLC) who have failed prior platinum-containing first-line chemotherapy or who have progressed within six months of first-line therapy. The median overall survival rate was 27 weeks and both this efficacy and the safety profile compares favorably with current medical treatments which often include palliative best supportive care. Best supportive care has been shown previously to have a median overall survival of 14 weeks and is the comparator arm for the ongoing randomized Phase 3 trial to evaluate picoplatin treatment in this patient setting. The final data were presented during a poster discussion session at the 1st European Lung Cancer (IASLC) and the European Society for Medical Oncology (ESMO)... Poniard's Press Release -

Boehringer Ingelheim : Data suggests promising overall survival and progression-free survival with Vargatef (BIBF 1120)

25 April 2008 - Latest phase II data for Boehringer Ingelheim’s new cancer drug in development presented- Monotherapy treatment with the triple angiokinase inhibitor¹ BIBF 1120 (planned tradename Vargatef ™) offers promising efficacy and is well tolerated in patients with advanced, relapsed non-small cell lung cancer (NSCLC), according to results from a phase II study in patients with lung cancer². Of particular note were results from a subset of 57 patients with ‘good disease state’ (ECOG performance status^* of 0 or 1): these patients experienced longer overall survival (median overall survival was 9.5 months), longer progression-free survival (PFS; median PFS was 2.9 months) and a higher stable disease rate of 59% compared with the overall study population. The results were presented today by Dr Joachim von Pawel from Asklepios Fachkliniken München-Gauting, Germany, at the 1st European Lung Cancer Conference jointly organized by IASLC and ESMO in Geneva, Switzerland... Boehringer Ingelheim's Press Release -

Biomoda : Allowance allows company to expand patent portfolio of technologies for early detection of lung cancer

April 16, 2008 - U.S. Patent and Trademark Office Grants Biomoda Notice of Allowance for Patent Protection for Additional Intellectual Property –Biomoda, Inc. (OTC Bulletin Board: BMOD) , a development stage medical diagnostics company, announced it has been granted a notice of allowance from the U.S. Patent and Trademark Office for its invention directed to the “Method for Prognosing Response to Cancer Therapy with 5,10,15,20-Tetrakis (Carboxyphenyl) Porphine.”

Biomoda’s innovative, non-invasive technology is designed for early lung cancer screening of large populations at a reasonable cost. With the technology, clinicians can identify cancerous or aberrant cells extracted from samples of lung sputum; cancerous cells glow red under fluorescent light and can be detected under a microscope.

Current diagnostic methods for lung cancer, including CT scans and X-rays, often detect the disease at more advanced stages. Biomoda’s technology compliments these tools by screening for signs of lung cancer at an earlier stage, ensuring that patients receive advanced tests at the appropriate time... Biomoda's Press Release -

Roche acquires Piramed

15 April 2008 - Roche gains access to important oncology target with potential for treating major cancers such as breast and lung; first drug candidate in phase I clinical testing
- Second research programme centred on potential target in inflammatory indications such as rheumatoid arthritis
Roche announced today that it will acquire Piramed Limited, a privately-owned UK company focusing on therapeutics targeting PI3-kinase (PI3-K). The PI3-K pathway is known to play an important role in disease progression and in resistance to chemotherapeutics in cancer cells.

Pre-clinical studies have demonstrated the activity of PI3-K inhibitors in a broad range of tumours such as breast and lung cancer, as well as their potential importance in treating inflammatory diseases such as rheumatoid arthritis... Roche's Press Release - [PDF] Piramed's Press Release -

Biocon Limited : Phase IIb trials for NSCLC for BIOMAb EGFR

April 22, 2008 - ... Biocon commences Phase IIb trials for Glioma and NSCLC for BIOMAb EGFR :
An open label, prospective, multi-centric study to evaluate the Safety And Efficacy of BIOMAb-EGFR™ (Nimotuzumab) as Induction and Maintenance Therapy in combination with Radiotherapy plus Temozolomide (Concomitant & Adjuvant) in Indian patients with Glioblastoma Multiforme is ongoing at 8 investigational sites across the country.
Another Clinical Trial designed as an open-label, randomized, comparative, multi-centric Study To Assess Safety And Efficacy Of BIOMAb-EGFR™ &Nimotuzumab& in Combination with Chemotherapy Versus Chemotherapy alone in the treatment of Patients with Stage IIIB / IV Non Small Cell Lung Cancer (NSCLC) is also being initiated at 11 sites.
The above Clinical Trials will enable Biocon's Oncotherapeutics division to expand its market share through label extensions... Biocon's Press Release -