MADISON, Wis., Jan. 17, 2012 /PRNewswire/ -- Novelos
Therapeutics, Inc. (OTCBB: NVLT), a pharmaceutical company
developing novel drugs for treatment and diagnosis of cancer, today
announced that it has enrolled the first patient in a U.S.
multi-center Phase 1b dose-escalation trial of its cancer-targeted
molecular radiotherapeutic compound (131)I-CLR1404 (HOT) in cancer
patients with advanced solid tumors. Details of the trial
design are available on www.clinicaltrials.gov ID: NCT01495663, or
at www.novelos.com in the 'Clinical Trials' section.
Glenn Liu, M.D., University of Wisconsin Carbone Cancer Center, is
the trial's principal investigator.
"Patients with advanced solid tumors need new, safer and more
effective therapies," said Dr. Liu. "Based on animal data and
initial data from a Phase 1a dosimetry trial, HOT appears to
deliver radiation directly and selectively to tumors and cancer
stem cells."
"The data from this trial will be combined with calculation of
effective doses for HOT based on quantitative positron emission
tomography (PET) tumor imaging data using LIGHT, our small-molecule
cancer-targeted PET imaging agent," said Harry Palmin, President
and CEO of Novelos. "Together, we believe this combination
will enable us to commence HOT Phase 2 proof-of-concept trials in
the first quarter of 2013 in advanced cancer patients with
significant unmet medical need."
About HOT
HOT (iodine-131 radiolabeled CLR1404) is a small-molecule,
broad-spectrum, cancer-targeted molecular radiotherapeutic that we
believe has first-in-class potential. HOT is comprised of a
small, non-pharmacological quantity of CLR1404 (COLD) acting as a
cancer-targeted delivery and retention vehicle and incorporating a
cytotoxic dose of radiotherapy (in the form of iodine-131, a
radioisotope that is already in common use to treat thyroid and
other cancer types). It is this "intracellular radiation"
mechanism of cancer cell killing, coupled with selective delivery
to a wide range of malignant tumor types that imbues HOT with
broad-spectrum anti-cancer activity. Selective uptake and
retention has also been demonstrated in cancer stem cells compared
with normal stem cells, offering the prospect of longer lasting
cancer remission. In 2009 we filed an IND with the FDA to
study HOT in humans. In early 2010 we successfully completed
a Phase 1a dosimetry trial demonstrating initial safety, tumor
imaging and pharmacokinetic consistency and establishing a starting
dose for a Phase 1b dose-escalation trial. The ongoing Phase
1b dose-escalation trial is aimed at determining the Maximum
Tolerated Dose of HOT. We expect to initiate HOT Phase 2
efficacy trials as a monotherapy for solid tumors with significant
unmet medical need as soon as a minimal efficacious dose is
established. We may determine such an effective dose upon
seeing a tumor response in the Phase 1b trial or calculating it
from ongoing PET imaging trials in cancer patients with
LIGHT. Preclinical in vitro (in cell culture) and
in vivo (in animals) experiments have demonstrated selective
killing of cancer cells along with a benign safety profile.
HOT's anti-tumor/survival-prolonging activities have been
demonstrated in more than a dozen xenograft models (human tumor
cells implanted into animals) including breast, prostate, lung,
glioma (brain), pancreatic, ovarian, uterine, renal and colorectal
cancers and melanoma. In all but two models, a single
administration of HOT was sufficient for efficacy. In view of
HOT's selective uptake and retention in a wide range of solid
tumors and in cancer stem cells, its single-agent efficacy in
xenograft models and its non-specific mechanism of cancer-killing
(radiation), we expect first to develop HOT as a monotherapy,
initially for solid tumors.
About Novelos Therapeutics, Inc.
We are a pharmaceutical company developing novel drugs for
the treatment and diagnosis of cancer. Our three
cancer-targeted compounds are selectively taken up and retained in
cancer cells (including cancer stem cells) versus normal
cells. Thus, our therapeutic compounds appear to directly
kill cancer cells while minimizing harm to normal cells. This
offers the potential for a paradigm shift in cancer therapy by
providing efficacy versus all three major drivers of mortality in
cancer: primary tumors, metastases and stem cell-based
relapse. LIGHT is a small-molecule cancer-targeted PET
imaging agent. We believe LIGHT has first-in-class potential
and Phase 1-2 clinical trials are ongoing. HOT is a
small-molecule, broad-spectrum, cancer-targeted molecular
radiotherapeutic that delivers radiation directly and selectively
to cancer cells and cancer stem cells. We believe HOT also
has first-in-class potential. HOT Phase 1b dose-escalation
trial is ongoing and we expect HOT to enter Phase 2 trials in the
first quarter of 2013 as monotherapy for solid tumors with
significant unmet medical need. COLD, a cancer-targeted
non-radioactive chemotherapy, works primarily through Akt
inhibition. We plan to file an IND for COLD in the first
quarter of 2013. Together, we believe our compounds are able
to "find, treat and follow"™ cancer anywhere in the body in a
novel, effective and highly selective way. For additional
information please visit www.novelos.com
INVESTOR CONTACTS
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J. Patrick
Genn, Vice President of IR
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Anne Marie
Fields, Senior Vice President
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Novelos
Therapeutics, Inc.
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Lippert/Heilshorn & Associates, Inc.
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Ph: (858)
775-7456
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Ph: (212)
838-3777
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Email:
pgenn@novelos.com
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Email:
afields@lhai.com
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Novelos Therapeutics, Inc.
Madison, WI
Boston, MA
This news release contains forward-looking statements. You
can identify these statements by our use of words such as "may,"
"expect," "believe," "anticipate," "intend," "could," "estimate,"
"continue," "plans," or their negatives or
cognates. Such statements are valid only as of today,
and we disclaim any obligation to update this information.
These statements are only estimates and predictions and are subject
to known and unknown risks and uncertainties that may cause actual
future experience and results to differ materially from the
statements made. These statements are based on our current
beliefs and expectations as to such future outcomes. Drug
discovery and development involve a high degree of risk.
Factors that might cause such a material difference include, among
others, uncertainties related to the ability to attract and retain
partners for our technologies, the identification of lead
compounds, the successful preclinical development thereof, the
completion of clinical trials, the FDA review process and other
government regulation, our pharmaceutical collaborators'
ability to successfully develop and commercialize drug candidates,
competition from other pharmaceutical companies, product pricing
and third-party reimbursement.
SOURCE Novelos Therapeutics, Inc.