Biotech company Cerulean
Pharma Inc. reported back in March 2013 that its potential treatment
of late-stage, non-small cell lung cancer (NSCLC), the most common form of
lung cancer, failed in a Phase 2b trials. Though the study of its
experimental, anti-tumor treatment, CRLX101, showed signs of activity including
tumor reductions and favorable safety profiles, the results did
not meet its primary efficacy endpoint, overall survival benefit.
Press release, below, addresses the publication of study results of CRLX101; and suggests preclinical behavior of
SOURCE: SOURCE Cerulean Pharma Inc.
Cerulean Announces
Publication of Data from Company's Lead Candidate, CRLX101, in Proceedings of
the National Academy of Sciences (PNAS)
Study results suggest preclinical behavior of
CRLX101 is translatable to humans
CAMBRIDGE, Mass., Sept. 9, 2013 /PRNewswire/ -- Cerulean Pharma Inc., a leader in
dynamically tumor-targeted nanopharmaceuticals, today announced the publication
of translational data on the company's lead candidate, CRLX101, currently in
Phase 2 trials. The study results, which are published in PNAS, indicate
that animal pharmacokinetic and pharmacodynamic data are translatable to
humans.
Results from Phase 1 and 2 clinical trials that have been correlated to
preclinical data and discussed in the paper include:
1.
A consistent manufacturing process across numerous lots of CRLX101 was
observed, as evaluated by particle size, polymer molecular weight and drug
loading, resulting in no significant differences in pharmacokinetics or urinary
excretion in patients treated with more than one clinical lot.
2.
Low patient-to-patient variations in plasma concentrations of CRLX101,
unlike what has been observed with liposomes.
3.
Similar time- and concentration-dependent behavior of camptothecin
concentration between patients and animals.
4.
Consistent pharmacokinetics upon repeat dosing in patients.
5.
Predictable release kinetics of camptothecin that is largely enzyme
independent.
6.
Slow release over time of the drug once in tumors, leading to a durable
inhibition of topoisomerase 1.
7.
Deep permeation of intact nanoparticles in mouse and human tumors, which
will enable the killing of tumor cells far from the vasculature.
"CRLX101 is designed to preferentially target tumors through leaky
neovasculature, achieve uptake into cancer cells, and release its payload over
time from within the cancer cells," said Mark E. Davis, professor of
chemical engineering at the California Institute of Technology, scientific
advisor to Cerulean, and inventor of CRLX101.
Scott Eliasof, vice president of research at Cerulean, commented:
"It's difficult to obtain data on how nanoparticles work in humans. As a
result, this evaluation comparing clinical trial and preclinical studies is
valuable because it demonstrates that in the case of CRLX101, animal studies
are a strong predictor of results in human trials."
The paper, "Correlating preclinical animal studies and human
clinical trials of a multifunctional, polymeric nanoparticle," was
co-authored by Mark E. Davis of the California Institute of Technology, Scott
Eliasof of Cerulean Pharma, and others at Cerulean, Calando Pharmaceuticals,
City of Hope Comprehensive Cancer Center and the California Institute of
Technology. It is available at http://www.pnas.org/content/early/2013/08/21/1309566110.full.pdf+html.
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 undrugable.
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
studies 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
funded by leading investors, including Polaris Venture Partners, Venrock, Lilly
Ventures, Lux Capital, and CVF, LLC. Cerulean is located in Cambridge,
Massachusetts. For more information, please visit the Company's website at http://www.ceruleanrx.com.
Media Contact:
Laura Kempke
Schwartz MSL
cerulean@schwartzmsl.com
+1 781-684-0770
SOURCE Cerulean Pharma Inc.
Web Site: http://www.ceruleanrx.com
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