|Pfizer gets approval for lung cancer therapy, QLT Shows Efficacy In Phase II Study and Emergent Announces Results of Study on Anthrax Vaccine|
|By Staff and Wire Reports|
|Monday, 29 August 2011 19:10|
Pfizer Inc. (NYSE:PFE) has received FDA approval of XALKORI® capsules – the first and only therapy specifically for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. The effectiveness of XALKORI is based on objective response rates and, as XALKORI received accelerated approval from the FDA, Pfizer is conducting post-marketing clinical trials to further demonstrate its clinical benefit.
On Tuesday, August 30 at 11:00 a.m. EST, Pfizer will convene a panel, including Pfizer Leadership, prominent lung cancer experts and patients who are treated with XALKORI, to discuss the implications of this important milestone for patients, oncologists and drug development at large. These panelists will be available for a Q&A session following opening remarks.
---QLT Inc. (NASDAQ:QLTI) announced results of its Phase II clinical study on the efficacy and safety of the Latanoprost Punctal Plug Delivery System (L-PPDS) in subjects with ocular hypertension (OH) and open-angle glaucoma (OAG).
The Phase II trial featured simultaneous placement of punctal plugs in both the upper and lower puncta for delivery of a daily drug load with a goal of enabling comparable clinical outcomes to that of daily administered Xalatan eye drops. The Company's overall drug development objective was a mean reduction in IOP of 5 mmHg or greater.
The primary endpoint in this Phase II study was the mean change in IOP from baseline (measured as mmHg) at 2 weeks. Secondary endpoints were the mean change in IOP from baseline at 4 weeks and mean percentage change in IOP from baseline at 2 weeks and 4 weeks. A total of 95 ITT (Intent to Treat) subjects were included in the L-PPDS treatments in this study.
Emergent BioSolutions Inc. (NYSE:EBS) announced results from a Phase 1a clinical trial evaluating an investigational anthrax vaccine, Anthrax Vaccine Adsorbed with CPG 7909 Adjuvant mixed at bedside, have been published in Vaccine.
In the study, which enrolled 69 subjects, the addition of the CPG 7909 adjuvant to BioThrax (Anthrax Vaccine Adsorbed), the only FDA-licensed anthrax vaccine, accelerated and enhanced the immune response to the vaccine in healthy volunteers. Trial subjects received three doses of either: (1) BioThrax alone, (2) 1 mg of CPG 7909 alone or (3) BioThrax plus 1 mg of CPG 7909, all given intramuscularly on study days 0, 14, and 28.
Data from the trial show that BioThrax plus CPG 7909 generated peak antibody responses that were 6-fold higher than those generated by BioThrax alone (232 μg/ml with BioThrax alone; 1465 μg/ml with BioThrax plus CPG 7909). BioThrax plus CPG 7909 also accelerated the time to reach the peak immune response seen following BioThrax vaccination by three weeks. Both of these findings were statistically significant (P<0.001). Early immune responses are important due to the rapid disease progression of anthrax.
BIOLASE Technology, Inc. (NASDAQ: BLTI), the world's leading dental laser manufacturer and distributor, today announced that it has received approval from the Health Canada-Medical Device Bureau to sell its Waterlase iPlus™ all-tissue dental laser systems throughout Canada.
China Cord Blood Corporation (NYSE:CO) ("CCBC" or the "Company"), China's leading provider of cord blood collection, laboratory testing, hematopoietic stem cell processing, and stem cell storage services, today announced its preliminary unaudited financial results for the first quarter of fiscal year 2012, which ended June 30, 2011.
CONMED Corporation (NASDAQ:CNMD), a medical technology company specializing in medical devices for surgical and patient monitoring markets, announced today that the Company will participate in the Stifel Nicolaus 2011 Healthcare Conference on Thursday, September 8, 2011 at 4:25 PM Eastern time, at the Four Seasons Hotel in Boston.
Life Technologies Corporation (NASDAQ:LIFE) today announced it will present at the UBS 2011 Global Life Sciences Conference on Tuesday, September 20 at 8:00am ET.
PharmAthene, Inc. (NYSE Amex:PIP), a biodefense company developing medical countermeasures against biological and chemical threats, announced today that in view of the relatively large increase in the price of its stock at the end of the trading day on August 25, 2011, the NYSE Amex has contacted the Company in accordance with its usual practice.
QIAGEN N.V. (NASDAQ:QGEN) today announced that its acquisition of all the ordinary shares in Cellestis Limited ("Cellestis") by a way of a scheme of arrangement ("Scheme") has been implemented.
Stellar Biotechnologies, Inc. (TSX-V: KLH) (PINKSHEETS:SBOTF) is pleased to announce that the National Science Foundation (NSF) has awarded Stellar's Phase IIB proposal ( http://www.nsf.gov/eng/iip/sbir/phase_iib.jsp ) a $498,560 grant for full implementation of commercial scale aquaculture systems for KLH (Keyhole Limpet Hemocyanin) production and development and deployment of a validated KLH-based immunogenicity assay.