|Quest test granted special FDA classification; Immunomedics Reports Final Results From Phase Ib/II Study|
|By Staff and Wire Reports|
|Friday, 20 January 2012 20:22|
Quest Diagnostics (NYSE:DGX), the world's leading provider of diagnostic testing, information and services, announced the FDA has granted a de novo classification petition to its STRATIFY JCV" Antibody ELISA testing service. STRATIFY JCV is the first blood test to be FDA market authorized for the qualitative detection of antibodies to the polyomavirus JC virus (JCV) for stratifying risk for progressive multifocal leukoencephalopathy (PML), an infrequent but serious brain infection, in patients with multiple sclerosis (MS) receiving TYSABRI® (natalizumab), a highly effective therapy for relapsing forms of MS.
The market authorization follows FDA approval today of a product label change for TYSABRI. The new label identifies JCV antibody status as a PML risk factor; other risk factors include duration of treatment with TYSABRI and prior immunosuppressant therapy use.
STRATIFY JCV was developed under an exclusive collaboration for the United States market with Biogen Idec (NASDAQ: BIIB), co-manufacturer with Elan Corporation, plc of natalizumab. The test employs technology licensed from Biogen Idec, and is exclusively offered through Quest Diagnostics' Focus Diagnostics laboratory in the United States. It is based on a test validated and performed by Focus Diagnostics in clinical trials.
"STRATIFY JCV is a great example of the capacity of pharmaceutical and diagnostic companies to collaborate to bring important medical innovations to market," said Kathy P. Ordonez, senior vice president, discovery and development, Quest Diagnostics. "The test has demonstrated its value as a tool that enhances PML risk assessment, and marks a significant step forward in the personalization of clinical management of MS patients who may benefit from natalizumab."
Approximately 50% to 60% of MS patients have been infected with JCV. In the general population, JCV can, in rare instances, reactivate and progress to PML, which may lead to severe neurological disability or death.
MS is an immune disorder that affects the central nervous system, can alternate between remission and relapse, and often progressively worsens over time. As many as 400,000 people have MS in the United States, and about 200 people are diagnosed each week.
Immunomedics, Inc. (NASDAQ:IMMU), a biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, announced repeated cycles of fractionated doses of its proprietary humanized antibody, clivatuzumab tetraxetan, labeled with yttrium-90 (90Y) and given in combination with gemcitabine, demonstrated therapeutic activity in patients with advanced, inoperable, pancreatic cancer.
A total of 100 patients with previously untreated Stage III or IV pancreatic cancer were enrolled into this open-label trial to receive gemcitabine once-weekly x 4 with 90Y-clivatuzumab tetraxetan on weeks 2, 3 and 4 (therapy cycle). The therapy cycle could be repeated until disease progression or patient displayed unacceptable toxicity. Ten patients withdrew early, while 90 patients, of whom 82 had the Stage IV (metastatic) disease, received 1 4 therapy cycles.
In Part I of this study, 38 patients were treated with 90Y-clivatuzumab tetraxetan at 6.5, 9, 12 or 15 mCi/m2 x 3, and a low, fixed gemcitabine dose of 200 mg/m2 x 4 for radiosensitization. Thirteen patients were retreated with the same cycle 1 - 3 times. The overall disease control rate, which includes complete response (CR), partial response (PR) and stable disease (SD), by CT-based RECIST criteria, was 58%, including 6 patients (16%) with PR and 16 patients (42%) with SD as best response.
The median overall survival (OS) for the 38 treated patients was 7.7 months, which compares favorably with other regimens for advanced pancreatic cancer. At the higher therapy doses (12 and 15 mCi/m2 of 90Y-clivatuzumab tetraxetan x 3), a median OS of 8.0 months was noted. For the 13 patients who received repeated cycles of the combination therapy, median OS improved to 11.8 months. (For more information, please refer to the Company's press release at www.immunomedics.com/pdfs/news/2011/PR06072011.pdf ).
Fifty-two patients were treated in Part II of this study to receive 3 weekly 90Y doses of 12 mCi/m2 and gemcitabine doses of 200, 600 or 1000 mg/m2 x 4, with 14 patients receiving repeated therapy cycles at the same gemcitabine dose but 90Y doses of 6.5, 9 or 12 mCi/m2. Results from 47 patients were reported at the Symposium. The disease control rate for the 200 mg/m2 group was 72%, with 19% PR and 53% SD. For the 600 and 1000 mg/m2 groups, the disease control rates were 63% (0% PR) and 68% (18% PR), respectively. Higher gemcitabine doses appeared to offer no advantage in treatment response over the lowest dose of 200 mg/m2. At the time of reporting, survival data were not available for this group of patients.
"These results from Part II of this clinical trial continue to support the use of antibody-directed radiation therapy with 90Y-clivatuzumab tetraxetan in patients with late-stage pancreatic cancer," remarked Cynthia L. Sullivan, President and Chief Executive Officer. "We are in discussions with FDA and opinion leaders regarding further development and eventual registration of this novel therapy modality," Ms. Sullivan added.
Treatments were well tolerated with no infusion reactions to radiolabeled clivatuzumab and few non-hematologic side effects. Hematologic suppression was transient after cycles 1 and 2.
Allos Therapeutics, Inc. (NASDAQ: ALTH) today announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued an opinion recommending against conditional approval of FOLOTYN® (pralatrexate injection) for the treatment of patients with peripheral T-cell lymphoma (PTCL) whose disease has progressed after at least one prior systemic therapy.
Amarantus BioSciences, Inc. (OTCBB:AMBS), a biotechnology company developing MANF, a first-in-class disease–modifying therapeutic protein, was interviewed by Stock News Now at the 2012 Biotech Showcase in San Francisco last week.
Boston Scientific Corporation (NYSE: BSX) will webcast its conference call discussing financial results for the fourth quarter and full year ended December 31, 2011 on Thursday, February 2, at 8:00 a.m. Eastern Time.
Cell Therapeutics, Inc. (NASDAQ: CTIC) announced today that, following discussions with the European Medicines Agency's ("EMA") Committee for Medicinal Products for Human Use ("CHMP"), the CHMP may issue an opinion on CTI's Marketing Authorization Application ("MAA") for Pixuvri in mid-February.
China Health Resource, Inc. (OTCBB: CHRI), announced today that the company has signed a 3 year exclusive agreement with a leading producer of Gastrodia in Pingwu, Sichuan.
Exelixis, Inc. (NASDAQ:EXEL) today reported positive preliminary data from the cohort of hepatocellular carcinoma (HCC) patients participating in the ongoing phase 2 randomized discontinuation trial (RDT) of cabozantinib.
Genomic Health, Inc. (Nasdaq: GHDX) today announced positive results of the first clinical decision making study of the Oncotype DX® colon cancer test that shows that Recurrence Score® (RS) result has a significant impact on treatment recommendations for stage II colon cancer patients.
Genzyme, a Sanofi company (NYSE: SNY) and one of the world’s leading biotechnology companies, and Veracyte, Inc., a molecular diagnostics company pioneering the emerging field of molecular cytology, today announced a global co-promotion partnership to provide a comprehensive solution for thyroid patients.
Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in flexible robotics and the developer of robotic technology for accurate 3D control of catheter movement, and the Center for Education, Simulation and Innovation (CESI) at Hartford Hospital today announced that Hansen Medical has selected Hartford Hospital to be a Center of Excellence for the Sensei® X Robotic Catheter System where electrophysiologists from around the globe will have the opportunity to be trained on flexible robotics with skilled and experienced physicians in a high-volume electrophysiology lab setting.
Idera Pharmaceuticals, Inc. (NASDAQ: IDRA) today announced favorable safety and efficacy results from a Phase 1b study of IMO-2055, a TLR9 agonist, in combination with Tarceva® and Avastin® in thirty-six patients with advanced non-small cell lung cancer (NSCLC) who have previously failed one or more prior therapies.
Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today announced updated data from the Phase 1b portion of an ongoing Phase 1b/2 clinical trial of saridegib (also known as IPI-926) in combination with the chemotherapy gemcitabine in patients with previously untreated, metastatic pancreatic cancer.
Insmed Incorporated (Nasdaq CM: INSM), a biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold previously placed on ARIKACE® (liposomal amikacin for inhalation) in patients with non-tuberculous mycobacteria (NTM) lung disease.
La Jolla Pharmaceutical Company (OTCBB: LJPC) (the “Company” and “La Jolla”) today announced that it has acquired global development and commercialization rights to GCS-100, a novel therapeutic, from privately held Solana Therapeutics, Inc. (“Solana”). GCS-100 is a first-in-class inhibitor of galectin-3, a novel molecular target implicated in cancer and chronic organ failure.
Medgenics, Inc. (NYSE: MDGN), the developer of a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today announced that the Company received notice of ‘Intention to Grant’ from the European Patent Office for the patent application entitled “USE OF DERMAL MICRO ORGANS,” with allowed claims covering a core element of its Biopump™ protein therapy technology.
Waters Corporation (WAT:NYSE) and Ireland's National Institute for Bioprocessing Research and Training (NIBRT) announced today the availability of the world's first database for glycan analysis by UltraPerformance Liquid Chromatography® (UPLC®).