Navigation Links
FDA Grants Cequent IND - Clears Way for First-Ever Clinical Trial of Orally Delivered RNAi Therapeutic: CEQ508, a tkRNAi Drug Candidate in Oncology
Date:12/10/2009

the choice of the adult FAP patient population, selection of cohort size, the dosing regimen, and duration of treatment. The trial is designed to determine safety and tolerability of CEQ508, starting with a dose-escalation phase in which patients will be given one of four escalating concentrations of the drug, contingent upon safety monitoring. This initial part of the clinical trial is expected to take approximately six months. Next, following a safety review, the trial plan calls for a stable-dose phase in which additional patients will receive the highest safe dose. The FDA will permit daily dosing of 18 or more patients for 28 days. A key readout and secondary objective of the trial includes analysis of biomarker beta-catenin expression changes in the gastrointestinal tract of patients determined from biopsy samples obtained prior to taking the drug and at the end of the dosing period.

Cequent's Vice President of Drug Development, Alison Silva, commented, "I want to commend the reviewers at CBER who have been very responsive, providing critical feedback immediately following our submission and throughout the application process. They worked with us so that we could address their questions quickly and effectively to reach a successful conclusion by our action date."

With the FDA approval of Cequent's clinical-trial protocol now in hand, the company has begun working with the proposed clinical center to obtain the necessary institutional approvals. Cequent expects to begin the Phase I clinical trial during the first quarter of 2010 at the Fred Hutchinson Cancer Research Center in Seattle, Washington, part of the Fred Hutchinson/University of Washington Cancer Consortium. The Cancer Consortium maintains a registry of FAP patients and is also one of 40 National Cancer Institute-designated comprehensive cancer centers nationwide. Gideon Steinbach, M.D., Ph.D., is slated to be the principal investigator (PI) of the Cequent trial. Dr. Steinbach is
'/>"/>

SOURCE Cequent Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. SRI International Receives National Institutes of Health Grants to Develop Improved Tomographic Imaging Technology
2. The Epilepsy Research Foundation and Milken Family Foundation Announce Prestigious Translational Research Grants for Two Pioneering Epilepsy Therapies
3. U.S. Food And Drug Administration (FDA) Grants Traditional Approval for INTELENCE(R) (etravirine)
4. FDA Grants GeoVax Labs, Inc. Request For Pre-IND Meeting
5. Ganeden Biotech Announces Grants for Early Investigators to Research Probiotic GanedenBC30
6. Cephalon Announces that FDA Grants Priority Review of its Supplemental New Drug Application for NUVIGIL as a Treatment for Excessive Sleepiness Associated with Jet Lag Disorder
7. Octapharma Accepting Applications for Research Grants on Immunotherapy, Coagulation Disorders and Critical Care
8. Swissmedic Grants Debiopharm Marketing Authorisation for Moapar(R), a New Therapeutic Avenue for the Treatment of Sexual Deviations
9. Swissmedic Grants Debiopharm Marketing Authorisation for Moapar(R), a New Therapeutic Avenue for the Treatment of Sexual Deviations
10. Oasmia: FDA Grants Paclical(R) Orphan Drug Designation for Ovarian Cancer in the USA
11. Rendell Administration Announces Health Research Grants From Tobacco Settlement Funds
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/2/2014)... MOUNTAIN VIEW, Calif. , Sept. 3, 2014 ... recently completed phase 2 placebo-controlled trial in pediatric ... a statistically significant increase in head circumference.  Decreased ... the disease. Rett syndrome is ... is usually diagnosed by 24 months of age. ...
(Date:9/2/2014)... , Sept. 2, 2014 Astellas has appointed ... property (IP) in the Americas. Kellerman will report directly ... general counsel at Astellas. In his new role, Kellerman ... with the business and manage the region,s intellectual property ... "I am very pleased to welcome Jim to ...
(Date:9/2/2014)... Reportlinker.com announces that a new market ... Asia-Pacific Infusion Therapy Device Market ... The Asia-Pacific ... pumps, syringe infusion pumps, disposable infusion pumps, IV ... are segmented based on the type of displacement ...
Breaking Medicine Technology:Edison Pharmaceuticals Announces Phase 2 Positive Clinical Results for EPI-743 in Rett Syndrome 2Edison Pharmaceuticals Announces Phase 2 Positive Clinical Results for EPI-743 in Rett Syndrome 3Leading Intellectual Property Counsel, James Kellerman, Joins Astellas as Vice President 2Asia-Pacific Infusion Therapy Device Market 2Asia-Pacific Infusion Therapy Device Market 3Asia-Pacific Infusion Therapy Device Market 4Asia-Pacific Infusion Therapy Device Market 5Asia-Pacific Infusion Therapy Device Market 6Asia-Pacific Infusion Therapy Device Market 7Asia-Pacific Infusion Therapy Device Market 8Asia-Pacific Infusion Therapy Device Market 9Asia-Pacific Infusion Therapy Device Market 10Asia-Pacific Infusion Therapy Device Market 11Asia-Pacific Infusion Therapy Device Market 12Asia-Pacific Infusion Therapy Device Market 13Asia-Pacific Infusion Therapy Device Market 14
... , , , , , , MUMBAI, India, Dec. ... IN, NSE: SUNPHARMA, BSE: 524715) today announced that Glass, Lewis ... that shareholders of Taro Pharmaceutical Industries Ltd. (Pink Sheets: TAROF) ... of directors, including all of its nominees for election or ...
... , SUNNYVALE, Calif., Dec. 22 Arrayit Corporation (OTC Bulletin ... announced that the Company has made a technological breakthrough in ... microarrays, which are tiny glass substrates that contain rows and ... diagnostics. The advance allows highly precise printing of as many ...
Cached Medicine Technology:Glass Lewis Advises Taro Shareholders to Hold Taro's Board Accountable for Its Failures 2Glass Lewis Advises Taro Shareholders to Hold Taro's Board Accountable for Its Failures 3Glass Lewis Advises Taro Shareholders to Hold Taro's Board Accountable for Its Failures 4Arrayit Corporation Announces Manufacturing Breakthrough 2Arrayit Corporation Announces Manufacturing Breakthrough 3
(Date:9/3/2014)... An inspiring story of the importance ... the season finale of “Extreme Weight Loss” Season Four. ... daughter from Highlands Ranch, Colo. who have a strained ... pounds. Their challenge is to team up to lose ... non-competitive approach to weight loss transformations, “Extreme Weight Loss” ...
(Date:9/3/2014)... Tulsa, OK (PRWEB) September 03, 2014 ... in the sales, installation, and support of Sage 100 ... named a Sage North America Million Dollar Club achiever ... 2013-2014 business year. Sage recognizes CS3 Technology and all ... to the overall success of Sage, its business partners ...
(Date:9/3/2014)... Gorda, FL (PRWEB) September 03, 2014 ... healthcare delivery, increases patient safety, decreases medical errors, ... providers. , To mark the important role ... in America, IHS and others across the U.S. ... Technology (NHIT) Week , September 16-20, 2014. With ...
(Date:9/3/2014)... September 03, 2014 Immersion Active ... received a silver medal in the 2014 Content Marketing ... Marketing Awards is the leading awards program for people ... of every medium and strategic purpose. , Immersion ... developed for its client Home Instead Senior Care®. This ...
(Date:9/3/2014)... OR (PRWEB) September 03, 2014 ... the use of appropriate evidence-based health care along ... parties benefit from the expertise of accredited independent ... the health care system. , As a core ... IROs often settle questions of medical necessity. Yet ...
Breaking Medicine News(10 mins):Health News:“Extreme Weight Loss”: Jeff and Juliana’s Journey begin at the University of Colorado Anschutz Health and Wellness Center 2Health News:CS3 Technology Named a Sage Million Dollar Club Achiever for 2013-2014 2Health News:Innovative Healthcare Solutions (IHS) Celebrates National Health IT Week September, 15-19, 2014 2Health News:Immersion Active Wins Silver for Email Strategy in 2014 Content Marketing Awards 2Health News:Independent Review Expands Its Scope: Case Studies in Context 2Health News:Independent Review Expands Its Scope: Case Studies in Context 3
... Healthcare practitioners can increase the number of patients with heart ... cent, helping them to reduce their risk of dying and ... Munk Cardiac Centre. Previous studies, including one by ... a cardiac illness, such as a heart attack, can reduce ...
... Randy Dotinga HealthDay Reporter , MONDAY, Feb. ... Bull, AMP and Rockstar have no health value and ... review finds. The increasingly popular, highly caffeinated drinks ... hyperactivity disorder (ADHD) or other health or emotional problems, ...
... MONDAY, Feb. 14 (HealthDay News) -- Most medical devices recently ... life-threatening or serious safety risks were initially approved for use ... research reveals. The findings call out for an overhaul ... the market in the first place, said the study team, ...
... have a subtype that is characterized by high levels ... tends to be more aggressive than other breast cancer ... is so aggressive could aid in the development of ... researchers, led by Lewis Chodosh, at the University of ...
... , MONDAY, Feb. 14 (HealthDay News) -- ... Afghanistan and Iraq and who were evacuated due to ... military personnel to return to duty, new research shows. ... Department of Defense civilians -- account for about 50 ...
... / MEDai, a leading provider of advanced clinical analytic ... version of Pinpoint Review, its real-time, clinical surveillance system ... set of clinical watch triggers, expanded core measure alerts ... Stay Prediction and Mortality Prediction. "Hospitals are ...
Cached Medicine News:Health News:Heart patients should be referred to Cardiac Rehabilitation before leaving hospital 2Health News:Heart patients should be referred to Cardiac Rehabilitation before leaving hospital 3Health News:Energy Drinks May Hurt Kids: Study 2Health News:Energy Drinks May Hurt Kids: Study 3Health News:Report Blames Speedy FDA Clearance for Medical Device Recalls 2Health News:Report Blames Speedy FDA Clearance for Medical Device Recalls 3Health News:Nonmilitary More Likely to Return to War Zone After Psych Condition 2Health News:Elsevier/MEDai enhances real-time clinical surveillance system for hospitals 2
... Foot Control allows hands-free operation in nerve ... or 5.0 mA) with SoloStim provides a ... fine control when close to nerve., ... nerve block products, including the clinically proven ...
... ,The Centiva/5 Critical Care Ventilator is your solution ... critical care environment. The Centiva has been designed ... size with high levels of performance. The Centivas ... patients bed and allows you the freedom to ...
... Mesh Elastic is a lightweight and large pore ... mesh is able to adapt to all movements ... honeycomb like structure with the large pores enables ... The mesh is ideal for incisional hernia repair ...
... a mesh plug to treat large or ... hernias and femoralhernias. The self-expanding plug perfectly ... completely. Premilene Mesh Self-Forming Plug is a ... Mesh. The plug corresponds with all properties ...
Medicine Products: