BioSpace.com

Biotech and Pharmaceutical
News & Jobs
Search the Site
 
   
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Browse Biotech Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

DIVERSITY

INVESTOR
Market Summary
News
IPOs

PROFILES
Company Profiles

START UPS
Companies
Events

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Biotech Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
eNewsletter Signup
Miles
Km80.5

   

Cerulean Pharma Inc. Announces First Patient Dosed In Phase 2 Clinical Trial Of CRLX101 In Combination With Avastin® In Relapsed Ovarian Cancer


2/11/2014 10:30:27 AM

free biotech news Get the latest biotech news where you want it. Sign up for the free GenePool newsletter today!

CAMBRIDGE, Mass.
, Feb. 11, 2014 /PRNewswire/ -- Cerulean Pharma Inc., a leader in dynamically tumor-targeted nanopharmaceuticals, today announced that the first patient has been dosed in an open label single-arm Phase 2 clinical trial of its lead candidate, CRLX101, in combination with Avastin (bevacizumab) in patients with relapsed ovarian cancer.

The Phase 2 combination therapy trial of this investigational treatment is being conducted at Massachusetts General Hospital (MGH) and the affiliated Harvard teaching hospitals under the direction of principal investigator Carolyn Krasner, M.D. The trial will investigate the rate of progression free survival at six months (PFS6) using RECIST (Response Evaluation Criteria in Solid Tumors) version 1.1 criteria in relapsed ovarian cancer patients treated with a combination of Avastin and CRLX101. Neither CRLX101 nor Avastin is approved for the treatment of ovarian cancer.

In a 29-patient single-arm Phase 2 monotherapy trial at the same hospitals, CRLX101 demonstrated single agent activity in previously treated late-stage ovarian cancer patients with multiple RECIST partial responses and the satisfaction of the primary efficacy endpoint of at least four of 29 patients achieving PFS6. In this CRLX101 monotherapy trial, the adverse events were generally low grade and manageable.

"When ovarian cancer recurs, it can be very difficult to treat because of increasing resistance to chemotherapy," said Dr. Krasner. "Based on our experience with CRLX101 in monotherapy, we are excited to transition into a CRLX101-Avastin combination trial to assess if pre-clinical synergies observed with the two agents translate into meaningful benefit for platinum resistant patients."

CRLX101 inhibits hypoxia-inducible factor-1a (HIF-1a) and topoisomerase-1. In pre-clinical models, CRLX101 has shown synergy with VEGF inhibitors, including Avastin. In an ongoing Phase 1b/2a clinical trial at the University of Pennsylvania, the combination of CRLX101 and Avastin at their respective maximum tolerated doses appears well-tolerated in late-stage renal cell carcinoma (RCC) patients while demonstrating signals of efficacy. The safety data from the RCC trial were considered by the MGH Institutional Review Board in approving use of the combination for ovarian cancer patients treated in this clinical trial.

"We are excited to embark on this latest trial of CRLX101," said Edward Garmey, M.D., chief medical officer of Cerulean. "In the past few months, preliminary results from an ongoing clinical trial in renal cell carcinoma suggest synergies between CRLX101 and Avastin. We are pleased to collaborate with Dr. Krasner to investigate this promising potential treatment for relapsed ovarian cancer. And we appreciate Roche-Genentech's support of this trial by providing the Avastin to be used in combination with CRLX101."

About CRLX101
CRLX101 is an investigational anti-cancer agent that inhibits topoisomerase 1 (topo 1) and hypoxia-inducible factor-1a (HIF-1a). Topo 1 is an essential cell replication enzyme and a commercially validated anti-cancer target. HIF-1a is a master regulator of cancer cell survival mechanisms such as cancer stem cell formation and is upregulated under hypoxic conditions created by traditional cancer therapies, for example anti-angiogenic agents and radiation. To date, HIF-1a has been undruggable. CRLX101 is a dynamically tumor-targeted nanopharmaceutical designed to concentrate in tumors and release its payload, camptothecin, over an extended period of time, prolonging drug exposure at the site of action. CRLX101 has been dosed in more than 200 patients, many for more than six months. Anti-tumor activity (multiple RECIST responses and prolonged stable disease) has been observed in three different tumor types in highly refractory treatment settings, as monotherapy and in combination with Avastin®. CRLX101 is currently in Phase 2 clinical development. More information on CRLX101 clinical trials can be found at www.clinicaltrials.gov.

About Cerulean Pharma Inc.
Cerulean Pharma Inc. is a clinical-stage company specializing in the development of dynamically tumor-targeted nanopharmaceuticals. Cerulean is applying its proprietary nanopharmaceutical platform to advance a new class of therapeutic agents to address significant unmet medical needs. With an initial focus in oncology, the Company's technology platform can be applied to a wide range of drug molecules, ranging from small molecules to peptides and RNAs. Cerulean is privately held and located in Cambridge, Massachusetts. For more information, please visit the Company's website at http://www.ceruleanrx.com.

Media Contact:
Laura Kempke
MSLGROUP
laura.kempke@mslgroup.com
+1 781-684-0770

SOURCE Cerulean Pharma Inc.



Help employers find you! Check out all the jobs and post your resume.

Read at BioSpace.com

   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES