Navigation Links
UPDATE: US Oncology Research Network Participates in Phase III Follow-up Study to BiPar's Investigational Cancer Drug BSI-201
Date:7/20/2009

US Oncology Research Network Participates in Phase III Follow-up Study to BiPar's Investigational Cancer Drug BSI-201

Phase II of the trial was presented in 2009 ASCO Plenary Session

US Oncology, Inc. today announced that US Oncology Research will participate in the BiPar Sciences' Phase III, Multi-center, Open-Label, Randomized Trial of Gemcitabine/Carboplatin (G/C), with or without BSI-201, in patients with Estrogen Receptor (ER), Progesterone Receptor (PR), and HER2-negative metastatic breast cancer.

Joyce O'Shaughnessy, M.D., co-chair of the US Oncology Breast Cancer Research Committee, associate director for clinical research for US Oncology and co-director of the Breast Cancer Research Program at Baylor-Charles A. Sammons Cancer Center and Texas Oncology, a US Oncology affiliate in Dallas, Texas, will lead the study as a follow-up to the Phase II study presented in a plenary session at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO) held May 29-June 2, 2009, in Orlando, Fla.

"We are very pleased to be participating in this clinical trial of BSI-201 which is a very promising new treatment for metastatic triple negative breast cancer," says Dr. O'Shaughnessy. "We expect that accrual will be very rapid within the US Oncology network and hope that this trial will lead to rapid FDA approval of what appears so far to be a well tolerated and effective therapy."

BSI-201 targets PARP, or poly (ADP-ribose) polymerase, a key enzyme involved in DNA repair and cell proliferation. By inhibiting the enzymatic activity of PARP, BSI-201 significantly enhances the anti-tumor effects of chemotherapy and has shown promising safety and efficacy results in patients with solid tumors.

"We are extremely pleased to be launching the Phase 3 clinical trial so rapidly after the close of the Phase 2 trial," said Barry Sherman, M.D., head of clinical development at South San Francisco-based BiPar Sciences, which is developing BSI-201. BiPar is a wholly owned subsidiary of Paris-based sanofi-aventis. "Our primary focus now is enrolling patients in this trial with a similar sense of urgency."

Physicians within the US Oncology network are expected to enroll more than 100 participants in this 420-patient study. Enrollment in the study opened July 17 in centers nationwide.

"The BSI-201 PARP Inhibitor is a potential game changing therapy in the treatment of triple-negative breast cancer. US Oncology Research is excited about the opportunity to continue our development collaboration with BiPar on this important potential new therapy," said Steve Smith, vice president and general manager of Research and Personalized Science for US Oncology Research. "We are eager to leverage the US Oncology Research network to support the study."

Patients targeted for the study include adults with histologically documented metastatic breast cancer with measurable disease that is ER-negative, PR-negative, and HER2- non-overexpressing. They will receive the chemotherapy combination of gemcitabine/carboplatin with or without BSI-201.

Patients must have measurable metastatic breast cancer with zero to two prior chemotherapy regimens for metastatic disease; adjuvant chemotherapy is allowed. Patients interested in learning more about participation should contact Laura Guerra, RN, CCRC, director of Research Clinical Operations and Women's Oncology and Early Phase Research with US Oncology at 281-863-1000 or visit www.usoncology.com.

Primary objectives of the study are to evaluate: overall survival (OS), progression-free survival (PFS), the objective response rate (ORR), and to further evaluate the safety and tolerability of BSI-201 in combination with gemcitabine and carboplatin.

Phase II of the study in triple negative breast cancer patients found that BSI-201 + G/C resulted in a statistically and clinically significant improvement in clinical benefit rate (CBR), median progression-free survival (PFS) and OS, compared with G/C alone. BSI-201 + G/C was well tolerated with adverse events (AEs) consistent with known safety profiles of G/C regimens.

J Clin Oncol 27:18s, 2009 (suppl; abstr 3)

About US Oncology Research

With experienced investigators and dedicated research nurses, US Oncology Research represents the largest research network specializing in Phase I-IV oncology clinical trials in the United States. US Oncology Research serves more than 80 sites in 200 locations with over 70 open trials being managed at any given time.

Additionally, the research network has accrued over 38,500 patients since its inception and contributed to the development of 36 of the latest cancer-fighting drugs approved by the FDA. For more information, visit the US Oncology Research section under About US Oncology on the company's Web site, www.usoncology.com.

About US Oncology

US Oncology, Inc., headquartered in The Woodlands, Texas, works closely with physicians, payers, biotechnology, pharmaceutical and medical equipment manufacturers, to identify and deliver innovative services that enhance patient access to advanced cancer care. US Oncology supports one of the nation's foremost cancer treatment and research networks, accelerating the availability and use of evidence-based medicine and shared best practices.

US Oncology uses its expertise to support every aspect of the cancer care delivery system--from drug development to distribution and outcomes measurement--enabling the company to help increase the efficiency and safety of cancer care. According to the company's last quarterly earnings report, US Oncology is affiliated with 1,227 physicians operating in 468 locations, including 95 radiation oncology facilities in 39 states. For more information, visit the company's Web site, www.usoncology.com.


'/>"/>
SOURCE US Oncology, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. ELADUR(TM) Development Update: DURECT Receives Orphan Drug Designation for Bupivacaine for Post-Herpetic Neuralgia
2. UPDATE: Infant Primates Given Vaccines on U.S. Childrens Immunization Schedule Develop Behavioral Symptoms of Autism
3. UPDATE: Nebivolol Lowers Blood Pressure in African Americans With Stage I-II Hypertension as Demonstrated in a Study Published in the Journal of Clinical Hypertension
4. UPDATE: New Report by Pediatricians Finds Gaps in Preparing to Protect Kids From Pandemic Flu, Offers Recommendations
5. UPDATE: Nile Therapeutics Announces Positive Phase 1a Results of CD-NP, a Selective NPR-B Agonist in Clinical Development for the Treatment of Heart Failure
6. Overview of Pixantrone Phase III Clinical Data Presentation at American Society of Clinical Oncology 2009 Annual Meeting Now Available at Clinical Care Options
7. Data From Clinical Study of bioTheranostics Molecular Diagnostic Test Presented at American Society of Clinical Oncology Annual Meeting
8. Video: Phase III Study Data With Vandetanib (Zactima(TM)) in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Presented at American Society of Clinical Oncology
9. Bayer Announces Leukine(R) Data Presentations at 45th American Society of Clinical Oncology (ASCO) Annual Meeting
10. Perceptive Informatics Enhances Investigator Application of New RECIST Version in Imaging-Based Oncology Trials
11. Video: Data on More Than 15 Novartis Oncology Compounds at ASCO Highlight Progress Toward Targeted Therapies for Diverse Tumor Types
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... , June 23, 2016 ... CAPR ), a biotechnology company focused on the ... announced that patient enrollment in its ongoing randomized ... has exceeded 50% of its 24-patient target. Capricor ... the third quarter of 2016, and to report ...
(Date:6/23/2016)... MOUNTAIN VIEW, Calif. , June 23, 2016 ... 9:00 a.m. CST on Thursday, July 7, 2016 , , ... kayla.belcher@frost.com ) , , , , EXPERT PANELISTS:  ... Sciences, Nitin Naik; Senior Industry Analyst, Christi Bird; Senior Industry Analyst, ... The global pharmaceutical industry is witnessing ...
(Date:6/23/2016)... , June 23, 2016 Revolutionary ... Oticon , industry leaders in advanced audiology ... of Oticon Opn ™, the world,s first internet ... possibilities for IoT devices.      (Photo: ... introduces a number of ,world firsts,: , ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... June 26, 2016 , ... ... have been diagnosed with endometriosis. These women need a treatment plan to not ... comprehensive approach that can help for preservation of fertility and ultimately achieving a ...
(Date:6/25/2016)... ... June 25, 2016 , ... Austin residents seeking Mohs surgery services, can now ... and to Dr. Russell Peckham for medical and surgical dermatology. , Dr. Dorsey brings ... The selective fellowship in Mohs Micrographic Surgery completed by Dr. Dorsey was under the ...
(Date:6/25/2016)... ... June 25, 2016 , ... "With 30 hand-drawn hand gesture animations, FCPX ... Austin - CEO of Pixel Film Studios. , ProHand Cartoon’s package transforms over ... Cut Pro X . Simply select a ProHand generator and drag it above media ...
(Date:6/25/2016)... ... June 25, 2016 , ... As a lifelong Southern Californian, Dr. Omkar ... M.D from the David Geffen School of Medicine at UCLA. He trained in Internal ... complete his fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai program where he had ...
(Date:6/25/2016)... ... ... On Friday, June 10, Van Mitchell, Secretary of the Maryland Department of Health ... of their exemplary accomplishments in worksite health promotion. , The Wellness at Work Awards ... at the BWI Marriott in Linthicum Heights. iHire was one of 42 businesses to ...
Breaking Medicine News(10 mins):