Biosystems International : Development of a Diagnostic Blood Test for Lung Cancer

PARIS-may 14, 2009 -Biosystems International a biotechnology company focused on the development of novel monoclonal antibody-based cancer diagnostics has initiated the development of an in vitro diagnostic blood test for lung cancer. This decision is based on the successful validation of a panel of monoclonal antibodies on multiple cohorts of lung cancer patients and control subjects.
The antibodies of the test under development were discovered using BSI’s patented monoclonal antibody proteomics platform which has delivered a panel of lung cancer specific antibodies that has been tested on 4 patient cohorts totaling 367 patients and 304 controls and demonstrates > 80% sensitivity and > 80% specificity (for comparison, the PSA test for prostate cancer screening has a sensitivity of 35% and specificity of 63%). Importantly, similar values were obtained on a subpopulation of 128 patients with stage I cancer, demonstrating the strong potential to develop the first blood test to detect early stage lung cancer when it is treatable by surgery resulting in a dramatic increase in the chance for survival. Furthermore, a subset of
antibodies discriminates between different histological subtypes, a finding which can aid in accurate diagnosis assuring appropriate treatment.
To confirm the specificity of the antibody panel to lung cancer, it has also been tested on control cohorts including subjects with non-malignant lung pathologies such as COPD, bronchial pneumonia, and fibrosis, as well as lung tumors of non-pulmonary origin. In all cases the antibodies were insensitive to these conditions as well as gender, treatment and smoking status... [PDF] Biosystems International's Press Release -

Clarient : New Gene Mutation Test to Help Select Therapy for Non-Small Cell Lung Cancer

June 16, 2009 - Clarient, Inc. (Nasdaq: CLRT), a premier anatomic pathology and molecular testing services resource for pathologists, oncologists, and the pharmaceutical industry, announced the launch of a new gene mutation test that can help physicians select the proper therapy for patients with non-small cell lung cancer (NSCLC). The test, called epidermal growth factor receptor (EGFR) mutation, has been validated as a laboratory-developed test and is now available to physicians and their patients... Clarient's Press Release -

Vision-Sciences : Advanced, Video-Based Bronchoscope and EndoSheath® Technology to Enthusiastic International Pulmonary Market

BERLIN- Vision-Sciences, Inc. (Nasdaq: VSCI) announced the international introduction of its new, advanced video bronchoscopy platform at the 18th Annual European Respiratory Society (ERS) conference in Berlin, Germany. Over 17,000 participants attended the scientific and educational conference, the largest in Europe and one of the most comprehensive ever in the field of lung health and disease.

Vision-Sciences’ new bronchoscopy system is the latest addition to its revolutionary 5000 Series video endoscopy line. The new bronchoscope provides high resolution video imaging and superior endoscopic functionality. It employs the company’s proprietary EndoSheath^® technology, for the first time allowing pulmonologists high performance bronchoscopy combined with the unparalleled practice efficiency and enhanced safety of the EndoSheath^® technology... Vision-Sciences' Press Release -

Varian Medical Systems : Clinicians in Netherlands Treat Lung Cancer Patients Using New RapidArc Radiotherapy Technology

Oct. 14, 2008 - Doctors in the Netherlands have used RapidArc technology from Varian Medical Systems (NYSE: VAR) to treat four early stage lung cancer patients in what is believed to be among the world's first treatments of their kind. Clinicians at VU University Medical Center in Amsterdam now plan to replace conventional stereotactic radiotherapy treatments with RapidArc for all such patients.

A 57-year-old male, diagnosed with a 1.2cm diameter non-small cell lung tumor in the right upper lobe and deemed unfit for surgery as a result of severe emphysema, was the first patient to receive the pioneering radiotherapy treatment at the hospital in early September... Varian Medical Systems' Press Release -

Quark : Publication of Study on Use of siRNA against Proprietary Target for Inhibiting Tumor Growth and Sensitization of Cancer Cells to Chemotherapy

October 13, 2008 - Quark Pharmaceuticals, Inc., a development-stage pharmaceutical company discovering and developing novel RNA interference (RNAi)-based therapeutics, announced that the journal Cancer Research published results on efficacy of siRNA targeting its proprietary target gene against non-small cell lung cancer (NSCLC) in the edition dated October 1, 2008. The paper, entitled “RNAi-Mediated Silencing of Nuclear Factor Erythroid-2–Related Factor 2 Gene Expression in Non–Small Cell Lung Cancer Inhibits Tumor Growth and Increases Efficacy of Chemotherapy,” reports on research performed in collaboration with Professor Shyam Biswal of the Division of Pulmonary and Critical Care Medicine, School of Medicine, Johns Hopkins University. The results provide a basis for a potential new drug candidate to be added to Quark’s pipeline.
The study examined efficacy of RNAi-mediated reduction of Nuclear Factor Erythroid-2–Related Factor 2 (Nrf2) expression in vitro and in in vivo mouse NSCLC xenograft models alone or in combination with chemotherapy. The results show that RNAi-mediated reduction of Nrf2 expression generates reactive oxygen species, suppresses tumor growth, and increases sensitivity to chemotherapeutic drug–induced cell death... Quark Pharmaceuticals' Press Release -

Aerovance : Aerovant Inhalation Powder is Well Tolerated in Asthma Patients

Oct. 7, 2008 – Aerovance Inc. reported pharmacokinetic (PK) and safety data from a Phase I trial of its Aerovant inhalation powder that demonstrate good tolerability with no evidence of local irritancy following asthma patients’ inhalation of a single 10 mg dose.

This 10 mg dose will be the highest of three doses investigated in Aerovance’s Phase IIb dose-ranging study, which is scheduled to begin early next year. Evidence gathered from nonclinical and clinical studies indicates the primary action of Aerovant is local to the lung, while the PK data confirm that the dry powder inhaler achieved the targeted lung dose. The data were presented by E. Burmeister Getz, Ph.D, at the European Respiratory Society (ERS) Annual Congress in Berlin... Aerovance's Press Release -

Aires Pharmaceuticals : Key Technology License Agreement with the National Institutes of Health

October 21, 2008 - Aires Pharmaceuticals Inc., a drug development company focused on developing therapies for pulmonary conditions, announced the signing of an exclusive license agreement with the U.S. National Institutes of Health for the patented use of a nitric oxide prodrug to treat cardiopulmonary conditions.

The technology, identified at the NIH’s National Heart, Blood and Lung Institute, shows that nitrite, which is converted by the body into nitric oxide, can be delivered as an effective treatment for pulmonary hypertension, myocardial infarction, transplantation and cerebral vasospasm. Aires Pharmaceuticals is developing Aironite™, a proprietary, inhalable formulation of nitrite, to treat pulmonary arterial hypertension (PAH). The company has Orphan Drug Status from the U.S. Food and Drug Administration and has completed its first Phase I clinical trial for this indication... Aires Pharmaceuticals' Press Release -

Novartis and Nektar Therapeutics Pulmonary Business

Novartis' Press Release :
Novartis to acquire Nektar Therapeutics pulmonary business unit, strengthening respiratory drug delivery capabilities
October 21, 2008 - Novartis has strengthened its capabilities for developing medicines that can be delivered via the lungs through a definitive agreement to acquire the pulmonary drug delivery business unit of Nektar Therapeutics (NASDAQ: NKTR) for USD 115 million in cash.

Important capabilities gained from Nektar, which has approximately 140 associates who will join Novartis and remain in San Carlos, California, include product formulation and delivery expertise along with a broad device platform. This transaction excludes Nektar's inhalation programs for insulin, vancomycin, ciprofloxacin and amikacin.

Novartis will utilize these skills to build on existing capabilities and accelerate its pipeline targeting life-threatening diseases such as chronic obstructive pulmonary disease (COPD), asthma and cystic fibrosis as well as the life-cycle management of late-stage development projects that are closer to regulatory submissions. Potential applications will also be assessed in other areas of the Novartis healthcare portfolio... Novartis' Press Release -


Nektar's Press Release :
Nektar Sells Pulmonary Business to Novartis For $115 Million and Nektar Retains Key Pulmonary Programs Including Amikacin Inhale, Inhaled Vancomycin, and Ciprofloxacin Inhalation Powder
Oct 21, 2008 - Nektar Therapeutics (Nasdaq: NKTR) announced that Novartis AG has agreed to acquire from Nektar specific pulmonary delivery assets, technology, and intellectual property for $115 million in cash.

"This agreement will allow us to focus our efforts on the development of novel therapeutics using our PEGylation and conjugate chemistry-based drug development platforms," said Nektar President and CEO Howard W. Robin. "The transaction also strengthens our balance sheet and significantly reduces expenses. It is a perfect example of our ability to monetize assets that had little future value for Nektar."

Novartis will assume ownership of certain dry powder and liquid pulmonary formulation and manufacturing assets, including capital equipment and manufacturing facility capital lease obligations. The agreement also transfers to Novartis approximately
140 Nektar personnel, as well as certain intellectual property and manufacturing methods. Additionally, Nektar will transfer manufacturing and royalty rights to the Tobramycin inhalation powder (TIP) program, already partnered with Novartis... Nektar's Press Release -

Ranbaxy & GSK : IND APPLICATION TO DCGI FOR RESPIRATORY INFLAMMATION CANDIDATE

October 13 , 2008 - Ranbaxy Laboratories Limited (Ranbaxy) announced that the Company has submitted an Investigational New Drug (IND) application to the Drug Controller General of India for permission to initiate Phase-I human clinical trials. The IND application is for the Respiratory Inflammation candidate that the Joint GSK-Ranbaxy steering committee had identified earlier last year.

Ranbaxy has successfully completed all the required regulatory safety and toxicity studies on the drug candidate and also plans to seek regulatory approval in other countries outside India in order to initiate Phase-I human clinical trials at the earliest... Ranbaxy Laboratories' Press Release -

Bayer Schering Pharma : Progress in Clinical Program for Riociguat

October 6, 2008 – Based on positive Phase II trial findings, Bayer Schering Pharma will move into Phase III trials with its oral agent riociguat (BAY 63-2521). Riociguat is the first member of a new class of vasodilating agents called soluble guanylate cyclase (sGC) stimulators. It is being investigated as a new approach for the treatment of different forms of pulmonary hypertension. Riociguat demonstrated significantly improved exercise capacity in a Phase II study in patients with chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary arterial hypertension (PAH) as compared to baseline values. The Phase III program for these indications is planned to be initiated in late 2008... Bayer Schering Pharma's Press Release -

APT Pharmaceuticals : Phase III Trial of Inhaled Cyclosporine following Lung Transplantation

SEPTEMBER 30, 2008 - Proceeds to Fund Completion of Phase III Trial of Inhaled Cyclosporine following Lung Transplantation - APT Pharmaceuticals, a specialty drug development company focused on inhaled treatments for serious lung diseases, announced the completion of a $32.3 million Series B financing. The financing was led by Three Arch Partners and joined by additional new investors, InterWest Partners and Pinnacle Ventures. Existing investors Charter Life Sciences, Great Point Partners, Versant Ventures and Vivo Ventures also participated in the round... APT Pharmaceuticals' Press Release -

NeoGenomics Laboratories Extends Its Cancer Testing Services Through Exclusive Agreement with Response Genetics, Inc.

September 29, 2008 – NeoGenomics Laboratories (OTCBB: NGNM), a national clinical reference laboratory specializing in high-complexity, cancer-specific testing, announced an exclusive agreement with



Response Genetics Inc. (Nasdaq: RGDX) to offer its proprietary ResponseDX: Colon™ and ResponseDX: Lung™ tests nationwide. ResponseDX: Colon™ and ResponseDX: Lung™ are proprietary PCR-based tests in a cost-effective panel format which serve to help oncologists make optimal therapeutic treatment decisions for patients with colorectal cancer (CRC) and non-small cell lung cancer (NSCLC)... [PDF] NeoGenomics Laboratories' Press Release -

BioView : Interim Results of Early Detection Lung Cancer Diagnostic Test

September 24, 2008 – BioView Ltd, (TASE: BIOV ) from Rehovot, Israel, reported results of its internal clinical trial of the non-invasive diagnostic test under development for early detection of lung cancer.

In the trial a total of 76 sputum samples were collected from four groups of patients:
1. Healthy inviduals that never smoked
2. Heavy smokers with no signs of lung cancer
3. Early stage lung cancer patients (Stage 1)
4. Advanced stage lung cancer patients

The sputum samples were blindly scanned and analyzed morphologically and genetically, with fluorescent probes exclusively licensed to BioView, on BioView’s automated Duet scanning station by Company personnel. The results of the test were classified as “Normal”, i.e. no cancer detected and “Abnormal”, i.e. Cancer detected. These results were then compared to the actual data received from the hospital of the patients’ condition.

The samples included 32 cases of lung cancer patients (about half of them early stage patients) and 44 samples taken from people with no clinical evidence of lung cancer. Thirty one of the thirty two (96.9%) sick patients were correctly diagnosed as “Abnormal” and thirty six of forty four (about 82%) healthy people were correctly diagnosed as “Normal”... BioView's Press Release -

Novartis : Early data show potential for imatinib to treat life-threatening form of pulmonary artery disease

October 8, 2008 - An early proof-of-concept study presented shows promising results for imatinib in the treatment of pulmonary arterial hypertension (PAH), a severe, incurable blood vessel disorder.

Preliminary findings from a 59-patient, multi-center Phase II clinical trial suggest imatinib provides a treatment benefit, as demonstrated by a significant improvement in pulmonary vascular resistance and a numerical increase in cardiac output, key hemodynamic measures used to monitor the progression of the disease. Improvements in the six-minute walk test, the primary endpoint of the study, approached, but did not reach, statistical significance... Novartis' Press Release -