|VSE Wins Multiple Award Health and Information Technology Contracts; Celldex’s CDX-011 Demonstrates High Response Rates|
|By Staff and Wire Reports|
|Wednesday, 23 May 2012 19:11|
VSE Corporation (NASDAQ:VSEC) reported it has been awarded a prime contract by the National Institutes of Health (NIH), an agency of the Department of Health and Human Services (HHS). The 10-year, multiple-award, indefinite-delivery/indefinite-quantity (IDIQ) government-wide acquisition contracts (GWAC), have a cumulative ceiling value of approximately $20 billion. The ceiling dollars are to be 100% federally funded.
VSEs IT, Energy and Management Consulting Group will perform the work, which includes on-going information technology (IT) integration and outsourcing support services through the NIH Information Technology Acquisition and Assessment Center (NITAAC) Chief Information Officer Solutions and Partners III (CIO-SP3) program. Task areas are designed to support the Federal Enterprise Architecture (FEA) and all IT services described in the FEA. VSEs work under the contract is expected to include routine and critical IT services for biomedical research and healthcare, IT operations and maintenance, infrastructure protection and information assurance, and enterprise management systems.
VSE CEO Maurice Mo Gauthier said, This is a great opportunity to continue to expand our presence in the federal health and information technology market place. We look forward to leveraging the synergies created by our talented employees and our diversified subcontractor teammates to serve the mission critical IT needs of NIH and the CIO-SP3 program.
Celldex Therapeutics, Inc. (NASDAQ: CLDX) announced preliminary results from the Company's randomized Phase 2b EMERGE study of CDX-011 (glembatumumab vedotin) antibody drug conjugate in patients with glycoprotein NMB (GPNMB) expressing, advanced, heavily pretreated breast cancer. Preliminary results suggest that CDX-011 induces impressive response rates compared to current, available therapies in patients with advanced, refractory breast cancers with high GPNMB expression (expression in e25% of tumor cells). In this high expressing patient population, treatment with CDX-011 resulted in a 32% overall response rate (ORR; includes confirmed and unconfirmed responses), whereas treatment with Investigators Choice (IC) single-agent chemotherapy resulted in a 13% ORR. CDX-011 also demonstrated strong response rates in patients with triple negative breast cancer across all levels of GPNMB expression (CDX-011 ORR of 21%; IC ORR of 0%), where treatment options are extremely limited. In addition, in patients with triple negative breast cancer who also highly express GPNMB, greater activity was observed (CDX-011 ORR of 36%; IC ORR of 0%). The ORR across all levels of GPNMB expression was 19% for the CDX-011 arm and 14% for the IC arm, and a direct, positive correlation was observed between increasing levels of GPNMB expression and increased CDX-011 response rates. Based on these data, the Company believes CDX-011 has significant promise as a targeted therapy for patients with breast cancer and high expression of GPNMB, and especially for those with triple negative disease.
While data in the study are not yet mature, in patients with high GPNMB in the CDX-011 arm, a trend of improvement in progression-free survival (PFS) has been observed. In patients with both triple negative breast cancer and high GPNMB expression, a statistically significant PFS benefit is currently observed (p=0.0032). Study data continue to mature and patients continue to be followed. The Company anticipates updating results in the fourth quarter of 2012.
The correlation with GPNMB expression rates and clinical responses in this study confirms the role of GPNMB as a potentially new and important cancer target, said Linda Vahdat, MD, Professor of Medicine, Chief of Solid Tumor Service and Director of the Breast Cancer Research Program at Weill Cornell Medical College and the lead investigator of the EMERGE study. These results are promising in this heavily pretreated patient population for which there are few treatment options left. With continued positive results, CDX-011 has the potential to offer a possible new and important targeted therapy.
GPNMB has been associated with the migration, invasion, and metastasis of breast cancer. It is also highly expressed in triple negative breast cancers where it is associated with increased risk of recurrence. The Phase 2b EMERGE study required patients tissue to have at least 5% of cells expressing GPNMB at entry and, based on the low threshold for marker positivity, 99% of patients screened for GPNMB expression met the entry requirement, allowing for a specific focus on expression pattern subgroups. A total of 122 patients were treated on the study, with 81 patients (81 evaluable) randomized to the CDX-011 arm and 41 patients (36 evaluable) to the IC single-agent chemotherapy arm. Greater than 98% of the patient population across both arms had Stage IV disease. Patients on the CDX-011 arm received a median of six prior courses of therapy and patients on the IC arm received a median of five prior courses of therapy. The study overall replicated previous data in all comers, but subgroup analyses show enrichment for improved outcome in triple negative and high expressing subsets. Adverse events prominent with the CDX-011 arm include rash and peripheral neuropathy.
Aetna (NYSE: ΑET) and Silverlink Communications, Inc. today announced that their SMS text program for members diagnosed with diabetes has been selected as a finalist in the 2012 TripleTree iAwards for Wireless Health.
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, and Plant Bioscience Limited (PBL), a technology development and intellectual property (IP) management company, announced today that they have entered into a licensing agreement. PBL has granted Alnylam a world-wide, non-exclusive license to the Baulcombe patent (U.S. Patent No. 8,097,710) for use in the field of human therapeutics. Financial terms were not disclosed.
Baxter International Inc. (NYSE: BAX) announced today that it will present at the Goldman Sachs 33rd Annual Global Healthcare Conference on Wednesday, June 6, 2012, at 2:00 p.m. PT.
Celldex Therapeutics, Inc. (NASDAQ: CLDX) today announced preliminary results from the Company’s randomized Phase 2b EMERGE study of CDX-011 (glembatumumab vedotin) antibody drug conjugate in patients with glycoprotein NMB (GPNMB) expressing, advanced, heavily pretreated breast cancer.
Cepheid (NASDAQ: CPHD) today announced that both Xpert® CT/NG and Xpert® CT have received CE marking, with shipments expected to begin immediately.
China Botanic Pharmaceutical Inc. (NYSE AMEX: CBP) ("China Botanic" or the "Company"), a developer, manufacturer and distributor of botanical products, bio-pharmaceuticals and Traditional Chinese Medicines ("TCM") in China, today announced that the Company recently attended the 111th China Import and Export Fair (the "Canton Fair") held in Guangzhou, China.
Gilead Sciences, Inc. (Nasdaq: GILD) announced today that the Marketing Authorisation Application (MAA) for cobicistat, submitted on April 26, 2012, has been validated by the European Medicines Agency (EMA).
Furiex Pharmaceuticals, Inc. (NASDAQ: FURX) today confirmed that Takeda Global Research & Development Centre (Europe) Ltd. received confirmation on the acceptance of the submission of a Marketing Authorization Application, or MAA, from the European Medicines Agency for alogliptin, a selective dipeptidyl peptidase IV, or DPP-4, inhibitor for the treatment of type 2 diabetes.
Insmed Incorporated (Nasdaq CM: INSM), a biopharmaceutical company, today announced that it has begun screening patients for its U.S. phase 2 clinical trial, Treatment with ARIKACE to Realize Greater Efficacy Trial (TARGET-NTM),of ARIKACE® (liposomal amikacin for inhalation) in patients with non-tuberculous mycobacterial (NTM) lung disease.
Mauna Kea Technologies (NYSE Euronext: MKEA, FR0010609263), the leader in the endomicroscopy market, today reported new data showing that utilizing Cellvizio, the world's smallest microscope, during needle-based procedures is safe and may help physicians more accurately differentiate benign and cancerous pancreatic cysts to determine with more certainty if the patient needs immediate surgery.
Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Nevirapine Tablets USP, 200 mg.
Mylan Inc. (Nasdaq: MYL) today reported that Moody's Investors Service ("Moody's") has upgraded the company's credit ratings, including the "Corporate Family Rating," to Ba1 from Ba2. Following this action, Moody's rating outlook is stable.
PAREXEL International Corporation (NASDAQ: PRXL) announced today that it will participate in the Goldman Sachs Healthcare Conference in Ranchos Palos Verdes, California.
Pfizer Inc. (NYSE: PFE) named Olivier Brandicourt as President and General Manager of the Emerging Markets and Established Products Business Units, effective June 1, 2012.
Seattle Genetics, Inc. (Nasdaq:SGEN) announced today that the validation period is complete and Health Canada has accepted for review its New Drug Submission (NDS) for the use of ADCETRIS (brentuximab vedotin) in relapsed Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL).
Senesco Technologies, Inc. (NYSE MKT: SNT), announced today that the characteristics and activity of SNS01 have been released on-line in Molecular Therapy, the official journal of the American Society for Gene & Cell Therapy.
Solos Endoscopy, Inc.'s (PINKSHEETS: SNDY) is pleased to announce that the Company is scheduled to commence its initiative to complete its ISO 13485 Certification and CE Mark initiative with Expert Resource beginning May 29, 2012.
Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced today that the Company’s President and Chief Executive Officer Dr. Jeremy Levin will host a conference call and webcast to discuss his recent transition to CEO, and provide an update on financial guidance for 2012 and general business on Thursday, May 24, 2012 at 8:00 a.m. Eastern Time.
Tonix Pharmaceuticals Holding Corp. (OTCBB: TNXP) (“TONIX” or the “Company”), a specialty pharmaceutical company developing therapies for challenging disorders of the central nervous system (“CNS”), including fibromyalgia syndrome (“FM”) and post-traumatic stress disorder (“PTSD”), today announced that Chief Executive Officer Seth Lederman, MD, was interviewed by CEOLive.TV.
Trim Holding Group (PINKSHEETS: TRHG) (OTCQB: TRHG) is pleased to announce that effective as of May 22, 2012, the Company amended its Articles of Incorporation for the sole purpose of changing its name from Trim Holding Group to HPIL Holding.
XenneX, a Division of LifeMap Sciences, Inc. and BioTime, Inc. (NYSE Amex:BTX), announced today the release of GeneCards®, Version 3.08, on May 20, 2012. The new release is available at www.genecards.org.