HUMAN GENOME SCIENCES : ENROLLMENT IN RANDOMIZED PHASE 2 TRIAL OF HGS-ETR1 IN NON-SMALL CELL LUNG CANCER

August 22, 2008 – Human Genome Sciences, Inc. (Nasdaq: HGSI) announced that it has completed the enrollment and initial dosing of patients in a randomize Phase 2 trial of HGS-ETR1 (mapatumumab) in combination with the chemotherapy agents paclitaxel and carboplatin as first-line therapy in advanced non-small cell lung cancer (NSCLC).

“There is an urgent medical need for effective treatment options for non-small cell lung cancer because current treatment strategies have only a minimal impact on survival,” said Joachim von Pawel, M.D., a principal investigator in the study from the Asklepios Fachkliniken München-Gauting, Germany. “The majority of patients who are newly diagnosed with non-small cell lung cancer have locally advanced or metastatic disease that is currently incurable. We look forward to evaluating the potential of mapatumumab plus chemotherapy to offer a new approach to the first-line treatment of this deadly disease.”

The NSCLC trial is a randomized, multi-center, open-label Phase 2 study to evaluate the efficacy and safety of HGS-ETR1 in combination with carboplatin and paclitaxel as first-line therapy in the treatment of advanced non-small cell lung cancer (Stage IIIB or IV). 111 patients have been randomly assigned to one of three treatment groups and treated with either the two-agent combination of carboplatin and paclitaxel or the three-agent combination of carboplatin, paclitaxel, and HGS-ETR1 at either 10 mg/kg or 30 mg/kg. HGS announced the initiation of the NSCLC trial In December 2007... Human Genome Sciences' Press release -

Rosetta Genomics : First Cancer Diagnostic Test Based on Rosetta Genomics' Proprietary MicroRNA Technology Receives Regulatory Approval

The Test Differentiates Squamous From Non-Squamous Non-Small Cell Lung Cancer (NSCLC), Classifying Squamous-Cell Carcinoma of the Lung With Sensitivity of 96 Percent and Specificity of 90 Percent - This is the First CLIA Approved Test Which Leverages MicroRNAs' Sensitivity as Biomarkers for Accurate Diagnosis of Lung Cancer -
July 22 , 2008- Rosetta Genomics, Ltd. (NASDQ: ROSG) announces that the first molecular test based on Rosetta Genomics' proprietary microRNA technology, developed and validated by Columbia University Medical Center (CUMC), has been approved for clinical use by the New York State Department of Health Clinical Laboratory Evaluation Program. CUMC is now finalizing the commercial aspects of this test and will announce its clinical availability to patients nationwide once details are finalized later this year... Rosetta Genomics' Press Release -

BioTrove and Gene Express : NIH Grant to Develop Novel Standardized Genetic Profiling Test

July 1, 2008 - BioTrove Inc. and Gene Express, Inc. announced their receipt of a two-year National Institutes of Health (NIH) grant, awarded in support of their proposed novel research of genetic biomarkers for lung cancer.
Part of the NIH competitive grant program "Innovative Technologies for Molecular Analysis of Cancer," the project will combine for the first time BioTrove's OpenArray™ nanofluidic polymerase chain reaction (PCR) technology platform, Gene Express standards for accurate and consistent PCR measurement, and the clinical expertise of the Mount Sinai School of Medicine, with the goal of creating a standardized genetic profiling test for indicators of lung cancer risk.

The exciting thing about this project is that we are combining proven PCR technologies and existing genetic knowledge to create a new tool with the potential to significantly impact patient care and treatment options for this deadly disease.. BioTrove's Press Release -

Cortex Pharmaceuticals : AMPAKINE Molecule CX717 Has Positive Effects in Opiate–Induced Respiratory Depression in a Phase IIa Clinical Study

August 6, 2008 — Cortex Pharmaceuticals, Inc. (AMEX: COR) reported that top-line data from its first Phase IIa study in opiate-induced respiratory depression (RD) demonstrated that a single oral dose of 2100mg of Ampakine® CX717 achieved statistical significance over placebo on the primary endpoint measure. These results are being presented at the Bank of Montreal Capital Markets Focus on Healthcare Conference in New York City on Wednesday morning, August 6, 2008 at 9:30AM (EDT) by Dr. Roger G. Stoll, President & CEO of Cortex.

This placebo controlled, double-blind, randomized two-way crossover trial (RD-02) was performed by Parexel’s clinical research unit in Europe. In this study, eight (8) volunteers per dose group each received either 900mg, 1500mg, or 2100mg of CX717 or matching placebo that was orally administered two hours before each subject received an intravenous infusion of the opiate agonist, alfentanil. The primary performance measures were derived from a CO2 re-breathing procedure that measured the breathing response of the subject to increased CO2 levels in the presence of alfentanil... Cortex Pharmaceuticals' Press Release -

Silence Therapeutics : important patent protection for lead internal development compound, Atu027

23 July 2008 – Silence Therapeutics plc (AIM: SLN), a leading European RNAi focused biotechnology company, announces new intellectual property cover for its lead product, Atu027. The European Patent Office announced on July 17, 2008 that it intends to grant a European patent covering Silence’s lead internal product candidate. This patent will give Silence broad exclusivity not only for Atu027, but for any siRNA targeting protein kinase N beta

The notice is based on European patent application EP 03 790 894.4. The claims deemed allowable by the European Patent Office are directed to various aspects of the use of protein kinase N beta, the gene target of Atu027. Among others, the claims are related to any siRNA molecule, including Atu027, directed against protein kinase N beta for use in the treatment of numerous cancers involving the PI 3-kinase pathway. Other claims are related to the use of protein kinase N beta for screening purposes and its use as a downstream target of the PI3-kinase pathway.

Atu027 is a proprietary AtuRNAi molecule currently in development for solid cancer indications, including gastrointestinal and lung cancers. The candidate is designed to silence the function of a novel kinase protein involved in tumour growth and metastases and utilises Silence Therapeutics’s proprietary drug delivery system AtuPLEX to deliver active drug into the appropriate cells following systemic administration... Silence Therapeutics' Press Release -

Medarex : Allowance of Investigational New Drug Application for Wholly-Owned Fully Human Anti-PD-L1 Antibody, MDX-1105

Aug. 5, 2008 - Medarex, Inc. (Nasdaq: MEDX)announced today the allowance of an investigational new drug application (IND) filedwith the U.S. Food & Drug Administration (FDA) forMDX-1105, for the treatmentof patients with selected advanced or recurrent solid tumors, specifically renalcell carcinoma, melanoma, non-small cell lung cancer or epithelial ovarian cancer. MDX-1105 is a fully human antibody that targets the PD-L1 pathway to promote enhanced T-cell immune responses against cancer and reverse T-cell inactivation in chronic infectious disease.
The open-label, multi-dose, dose-escalation Phase 1 clinical trial is expected to enroll up to 46 patients with selected advanced or recurrent solid tumors. This trial is designed to establish and evaluate the safety, tolerability and maximum tolerated dose, as well as preliminary pharmacodynamics and efficacy, of MDX-1105... Medarex's Press Release -

Innovotech : The Hospital for Sick Children and St Michael's Hospital to Evaluate bioFILM PA Test

July 29, 2008 - Innovotech Inc. (TSX VENTURE:IOT) is pleased to announce a three year study by the Hospital for Sick Children and St. Michael's Hospital to evaluate bioFILM PA^TM, Innovotech's novel biofilm antimicrobial susceptibility test, in the selection of antibiotics to treat lung infections in cystic fibrosis patients.

"bioFILM PA^TM is a Health Canada registered product, and is therefore available for use by physicians and diagnostic laboratories in the treatment of a host of biofilm respiratory infections" says Dr Bhavin Rawal, Product Manager, Innovotech. "Our early results in cystic fibrosis show promise, so it is appropriate to continue the evaluation of bioFILM PA^TM, particularly with the Hospital for Sick Children and St Michael's Hospital, given their international reputation in this field."... Innovotech's Press Release -

GlobeImmune : CRADA with the National Institutes of Health to Develop Cancer Therapeutics

July 9, 2008 - GlobeImmune, Inc. announced the signing of a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) at the National Institutes of Health (NIH) to jointly develop products intended to treat a variety of cancers. GlobeImmune will utilize its proprietary Tarmogen® technology to develop multiple immunotherapy products expressing various cancer antigens provided by the NIH and the NIH will conduct and fund preclinical and early clinical development of the product candidates. Dr. Jeffrey Schlom, Chief of the Laboratory of Tumor Immunology and Biology at the NCI, will be the principal investigator for these studies. CEA (carcinoembryonic antigen), the first cancer antigen to be evaluated in this collaboration, is over-expressed in a number of human cancers, including over 90% of gastrointestinal cancers (colorectal, pancreas), 70% of non-small cell lung cancers (NSCLC) and 50% of breast cancers. Dr. Schlom’s group has already published two manuscripts from the NCI-GlobeImmune preclinical collaboration (Bernstein et al, Vaccine (2008) 26, 509-521; and Wansley et al, Clinical Cancer Research; July 1, 2008). Preclinical studies performed by Dr. Schlom’s group may be translated into NCI-funded clinical programs with promising Tarmogen candidates... GlobeImmune's Press Release -