Navigation Links
OncoGenex Announces Completion of a Special Protocol Assessment (SPA) Amendment with the FDA Increasing Patient Eligibility for the Custirsen Phase III Prostate Cancer SATURN Clinical Trial
Date:9/19/2011

BOTHELL, Wash. and VANCOUVER, British Columbia, Sept. 19, 2011 /PRNewswire/ -- Today OncoGenex (NASDAQ: OGXI) announced that the company has successfully completed an amendment to the approved SPA with the U.S. Food and Drug Administration (FDA) to expand the inclusion criteria for the Prostate Cancer SATURN Clinical Trial - a Phase III study testing whether their experimental drug custirsen, also known as OGX-011/TV-1011, can improve quality of life by reducing cancer pain for more than 12 weeks in men with metastatic castrate-resistant prostate cancer (mCRPC). As part of the approved amendment to the protocol and the SPA, patients may now receive either docetaxel re-treatment or cabazitaxel as second-line taxane chemotherapy. The study design remains the same; all patients must have stable pain at study entry and will be randomized to receive custirsen or placebo in conjunction with taxane chemotherapy.

"Until recently, docetaxel was the only standard of care for chemotherapy treatment of mCRPC with a demonstrated survival benefit," said Dr. Tomasz Beer, the study's principal investigator in the United States.  "With the recent approval of cabazitaxel for mCRPC treatment after docetaxel, men have a new option that extends survival.  In an effort to improve the palliative benefits of this new treatment, we are evaluating custirsen with cabazitaxel for pain palliation. Pain palliation in patients treated with cabazitaxel was reported at 9.2% and pain is one of the most common and devastating consequences of very advanced prostate cancer."

Custirsen is an experimental drug that is designed to block the production of a protein that is associated with treatment resistance in many cancers. In Phase II trials, custirsen combined with docetaxel as either first-line or second-line chemotherapy showed a 6.9 month improvement in overall survival over doc
'/>"/>

SOURCE OncoGenex Pharmaceuticals
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. OncoGenex Expands Clinical Development of OGX-427 with a Phase 1 Clinical Trial in Bladder Cancer
2. Isis Pharmaceuticals to Receive $10 Million From OncoGenex License of OGX-011 to Teva
3. OncoGenex Pharmaceuticals to Participate in Panel Discussion on Novel Cancer Treatments at RBC Capital Markets Healthcare Conference
4. OncoGenex Announces Data Highlighting OGX-427 at American Association of Cancer Research (AACR) 102nd Annual Meeting 2011
5. OncoGenex Pharmaceuticals, Inc. Reports Financial Results for Second Quarter 2011 and Provides Update on Development Activities
6. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
7. EDAP Announces Launch of Clinical Study Combining HIFU and Chemotherapy for Localized Aggressive High Risk Prostate Cancer
8. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
9. ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer
10. DOV Pharmaceutical, Inc. Announces Successful Phase Ib Results for DOV 21,947
11. Phosphagenics Announces Positive Phase 1b Transdermal Insulin Clinical Trial Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/20/2014)... SAN DIEGO , Oct. 20, 2014 /PRNewswire/ ... the industry leader in bioactive lipid-targeted therapeutics, received official ... company has been granted another key patent supporting ... This newly issued patent, European patent No. 2087002, ... drug substance in Lpath,s two lead compounds, iSONEP ...
(Date:10/20/2014)... , Oct. 20, 2014   Mary,s Medicinals ... for Caring, is a 4-Star Sponsor of Operation ... Veterans with unique products, programs and services to assist ... freedom. Key Facts: , An ... is a safe and effective treatment for pain, Post-traumatic ...
(Date:10/20/2014)... 20, 2014  BioPontis Alliance for Rare Disease ... announced today the creation of a joint venture ... the rare disease known as Charcot- Marie-Tooth (CMT) ... model earlier this month. Today,s partnership announcement with ... model where researchers and all CMT dedicated organizations ...
Breaking Medicine Technology:Lpath Granted Key European Patent Related to iSONEP and ASONEP Programs 2Lpath Granted Key European Patent Related to iSONEP and ASONEP Programs 3Lpath Granted Key European Patent Related to iSONEP and ASONEP Programs 4Mary's Medicinals Announces 4-Star Sponsorship of Operation Grow4Vets 2Mary's Medicinals Announces 4-Star Sponsorship of Operation Grow4Vets 3The Hereditary Neuropathy Foundation and BioPontis Alliance for Rare Disease Partner to Develop Treatments for Charcot-Marie-Tooth 2The Hereditary Neuropathy Foundation and BioPontis Alliance for Rare Disease Partner to Develop Treatments for Charcot-Marie-Tooth 3
... 3 Despite the pop in the shares of Dendreon ... been approved by the FDA, the biotech sector failed to build ... month with the Burrill Biotech Select Index dropping 2 percent in ... including Amgen and Gilead Sciences cut their profit forecasts citing the ...
... , , ... Bowel Control and Prevent Clinical Complications for People With,Stomas. , , ... GI, located in the Misgav Venture Accelerator, has reported,encouraging interim results in its animal trials of the ... , , ...
Cached Medicine Technology:Biotech Posts Weak Performance in April 2Biotech Posts Weak Performance in April 3Biotech Posts Weak Performance in April 4Stimatix GI Reports Encouraging Interim Results 2
(Date:10/20/2014)... York, NY (PRWEB) October 20, 2014 ... be introduced in the U.S., has a lot to celebrate ... when our country recognizes the achievements and contributions of Americans ... the anniversary for Punzoné, and today it shares its favorite ... take a trip to Italy - even if it is ...
(Date:10/19/2014)... Hastings and Hastings, a Phoenix personal injury ... the greater Phoenix area and across Arizona reports record ... catastrophic automobile accidents. Statistics have indicated a steady increase ... As such, Hastings and Hastings has seen a steady ... who have been injured through no fault of their ...
(Date:10/19/2014)... 19, 2014 Dr. Babatunde Osotimehin, Executive ... news of a ceasefire agreement that is expected to ... girls who were kidnapped from the north-eastern Nigerian town ... captivity long enough, and it is high time they ... Dr. Osotimehin. , "We owe it to these girls ...
(Date:10/19/2014)... October 20, 2014 Recently, Top10BestSEOHosting.com ... announced that JustHost, GoDaddy and HostMonster are the ... VPS (Virtual Private Server) is the method of ... each of which has the appearance and capabilities ... is why the site pays close attention to ...
(Date:10/19/2014)... October 19, 2014 Visual Impact ... has just been released to the public generating ... body building and fitness community. The commotion surrounding ... DietsAndFitnessGuides.com's Vin Delmonico prompting an investigative review. , ... hitting what is commonly known as a training ...
Breaking Medicine News(10 mins):Health News:Celebrate Italian Heritage Month With Authentic Cocktails from Punzoné: The Only Ultra Premium Line of Organic Imported Italian Vodka 2Health News:Celebrate Italian Heritage Month With Authentic Cocktails from Punzoné: The Only Ultra Premium Line of Organic Imported Italian Vodka 3Health News:Celebrate Italian Heritage Month With Authentic Cocktails from Punzoné: The Only Ultra Premium Line of Organic Imported Italian Vodka 4Health News:Hastings And Hastings Reports Record Demand In 2014 For Legal Representation With Regard To Catastrophic Automobile Accidents 2Health News:Hastings And Hastings Reports Record Demand In 2014 For Legal Representation With Regard To Catastrophic Automobile Accidents 3Health News:The Best VPS Hosting Suppliers In The Market Unveiled By Top10BestSEOHosting.com 2Health News:Visual Impact Frequency Training Review: Rusty Moore's Latest Fitness Guide Released 2
... , NEW YORK (March 16, 2011) -- On March ... the 2nd World Congress on Interventional Therapies for Type ... surgery as a treatment option. The three-day meeting, hosted ... City, will bring together physicians, scientists and policymakers representing ...
... organized follow-up care for depression effectively and efficiently, according ... patients that the Journal of General Internal Medicine ... five months, compared to the half of the patients ... had three online care management contacts with a trained ...
... News) -- Newly proposed national standards for mercury, arsenic ... prevent as many as 17,000 premature deaths and 11,000 ... Protection Agency. The proposed standards, released Wednesday by ... also prevent 120,000 cases of childhood asthma symptoms and ...
... This release is available in French . ... projects on regenerative medicine and nanomedicine received $16 million in ... Research (CIHR) and the Canadian Space Agency (CSA), were announced ... Member of Parliament for Oshawa; Dr. Jane Aubin, Scientific Director ...
... By Maureen Salamon HealthDay Reporter , ... be wise to avoid chatting on cell phones while ... more risky for that age group than for college ... Illinois, 18 older adults aged 59 to 81 and ...
... -- Children and adolescents growing up with inflammatory bowel disease ... by researchers at McMaster University and the McMaster Children,s Hospital. ... online, shows children and youth with the most common ... per cent lower than other children their age, and their ...
Cached Medicine News:Health News:Diabetes Surgery 2nd World Congress 2Health News:Diabetes Surgery 2nd World Congress 3Health News:Diabetes Surgery 2nd World Congress 4Health News:Diabetes Surgery 2nd World Congress 5Health News:Online messaging delivers follow-up care for depression 2Health News:EPA Proposes Tougher Air Pollution Rules for Power Plants 2Health News:Important funding for nanomedicine research to improve diagnosis and treatment 2Health News:Important funding for nanomedicine research to improve diagnosis and treatment 3Health News:Crossing Street While on Cell Phone Risky for Seniors 2Health News:Youth with IBD are less fit than their peers: McMaster study 2
... was the first device ... after diagnostic and interventional ... It is a collagen-based ... for immediate sheath removal ...
... VasoSeal VHD was ... rapidly stop bleeding after ... and radiology procedures. It ... sealing device approved for ...
... VasoSeal VHD was ... rapidly stop bleeding after ... and radiology procedures. It ... sealing device approved for ...
... VHD was the first ... bleeding after diagnostic and ... procedures. It is a ... approved for immediate sheath ...
Medicine Products: