Novelos Therapeutics, Inc. (OTCBB: NVLT), a
biopharmaceutical company developing therapeutics to treat cancer,
announced that today a poster highlighting positive results in a
Phase 2 trial of NOV-002 in combination with neoadjuvant
chemotherapy treatment in patients with stage IIB-IIIC HER-2/neu
negative invasive breast cancer is being presented by the Braman
Family Breast Cancer Institute at Sylvester Comprehensive Cancer
Center at the University of Miami Miller School of Medicine at the
AACR Breast Cancer Symposium in San Antonio, TX. Alberto Montero,
MD, Assistant Professor of Medicine at the Miller School and
medical oncologist at Sylvester, is the Principal Investigator. The
poster, Phase 2 study of neoadjuvant treatment with cellular redox
modulator NOV-002 in combination with doxorubicin and
cyclophosphamide followed by docetaxel (AC-T) in patients with
stage II-III HER-2(-) breast cancer, can be viewed at
www.novelos.com ‘Our Products’, ‘NOV-002’ section.
The Phase 2 open-label, single-arm, Simon 2-Stage breast cancer
trial was designed to determine if preoperative administration of
NOV-002 in combination with doxorubicin and cyclophosphamide
followed by docetaxel (AC-T) results in at least a doubling in
the rate of pathologic complete response (pCR) compared
to a historical control. The trial efficacy criterion of 12 pCRs
was met in July 2010 prior to all patients completing the
trial. The Phase 2 trial design can be found on
www.clinicaltrials.gov – ID: NCT00499122, or via a link at
www.novelos.com ‘Clinical Trials’ section.
“In this trial where now 41 breast cancer patients have been
enrolled from three different hospitals we have 15 confirmed
pathologic complete responses out of 38 patients (39%) who have
undergone surgery, which is higher than what has been previously
reported with preoperative chemotherapy, consisting of doxorubicin
and cyclophosphamide followed by docetaxel, in HER-2 negative
breast cancer patients,” said Dr. Montero. “By comparison the
published pCR rate in several trials with an anthracycline followed
by a taxane chemotherapy in patients with HER-2 negative breast
cancer is in the range of 10-20%. These results I believe indicate
that further investigation of NOV-002 plus chemotherapy in breast
cancer is warranted.”
“The efficacy seen in this trial is of particular interest in
relation to our growing understanding of NOV-002’s mechanism of
action,” said Christopher Pazoles, Ph.D., Vice President of
Research & Development of Novelos. “Recent findings suggest
that, due to its anti-tumor immunomodulatory activities, NOV-002
may be particularly well-suited for combination with certain
‘immunogenic’ chemotherapy agents including cyclophosphamide and
doxorubicin which are commonly used to treat breast cancer and are
part of the treatment regimen used in this trial.”
Additionally, on November 30, 2010, Novelos effected a share
exchange by issuing 340,935,801 shares of common stock in exchange
for all outstanding shares of two series of preferred stock. The
preferred stock represented a cumulative liquidation preference of
$27.3 million prior to exchange into common stock and had been
convertible at $0.65 per common share. In the share exchange, the
common stock was issued at $0.08 per common share, calculated as
the liquidation preference divided by the number of shares issued,
representing a 100% premium over market price. The share exchange
eliminated special voting rights previously held by the preferred
stockholders, $2.4 million of accumulating annual dividends and the
$27.3 million liquidation preference. Following the share exchange,
Novelos has approximately 453 million shares of common stock
outstanding.
“We are very pleased that NOV-002 demonstrated positive results
in this Phase 2 neoadjuvant breast cancer trial, and we will
continue to explore NOV-002 development in combination with
immunogenic chemotherapy,” said Harry Palmin, President and CEO of
Novelos. “Meanwhile, the recently completed share exchange
simplifies our capital structure and is expected to facilitate
ongoing efforts to expand our oncology pipeline through licensing
or strategic acquisition.”
About Breast Cancer
Breast cancer remains a serious public health concern throughout
the world. According to the American Cancer Society, approximately
192,000 women in the U.S. were expected to be diagnosed with breast
cancer in 2009, and approximately 41,000 were expected to die from
the disease. Neoadjuvant or preoperative systemic chemotherapy is
commonly employed in patients with locally advanced stage-III
breast cancer and in some patients with stage-II tumors.
Administration of neoadjuvant chemotherapy reduces tumor size, thus
enabling breast conservation surgery in patients who otherwise
would require a mastectomy. Furthermore, several studies have shown
that pathologic complete response (pCR) following neoadjuvant
chemotherapy is associated with a significantly higher probability
of long-term survival. However, only a small fraction of patients
with HER-2 negative breast cancer achieve a pCR with standard
neoadjuvant chemotherapy.
About NOV-002 for Breast Cancer
Cytotoxic chemotherapy is generally regarded as
immunosuppressive because of toxicity towards dividing cells in the
bone marrow and peripheral lymphoid tissue. It is now understood,
however, that some chemotherapeutic agents referred to as
“immunogenic” may enhance the antitumor effects of immunotherapy by
acting directly on the tumor and host environment. Immunogenic
chemotherapy agents commonly used in the treatment of breast cancer
include cyclophosphamide, anthracyclines (such as doxorubicin) and
gemcitabine. NOV-002 is believed to act via generation of oxidative
signals that mimic physiological regulatory mechanisms for a
variety of redox-sensitive cell processes and functions. In tumors,
this results in inhibition of cell proliferation and of tumor
invasiveness/metastasis. Of particular interest in the context of
breast cancer therapy, NOV-002 displays multiple forms of in vivo
immunomodulation which, when combined with immunogenic
chemotherapy, may increase anti-tumor efficacy. Thus, NOV-002 alone
increased effector T cell responsiveness to tumor antigens and
elevated levels of memory T cells in tumors and spleen in animal
tumor models. When combined in such models with the immunogenic
chemotherapy agent cyclophosphamide, NOV-002 increased survival and
decreased tumor growth compared to chemotherapy alone. It also
inhibited the activity of myeloid-derived T cell suppressor cells.
Such data supports the hypothesis that the immunomodulatory
activities of NOV-002 may enhance the anti-cancer efficacy of
immunogenic chemotherapy such as that commonly used in treating
breast cancer.
About Sylvester Comprehensive Cancer Center
Sylvester Comprehensive Cancer Center at the University of Miami
Miller School of Medicine opened in 1992 to provide comprehensive
cancer services and today serves as the hub for cancer-related
research, diagnosis, and treatment at UHealth—University of Miami
Health System. Sylvester handles 1,300 inpatient admissions
annually, performs 3,000 surgical procedures, and treats more than
4,300 new cancer patients. All Sylvester cancer specialists are on
the faculty of the Miller School of Medicine, South Florida’s only
academic medical center. In addition, Sylvester physicians and
scientists are engaged in more than 200 clinical trials and receive
$41 million annually in research grants. Sylvester at Deerfield
Beach opened in 2003 to better meet the needs of residents of
Broward and Palm Beach counties, and now offers appointments with
30 physicians from 14 of Sylvester’s 15 Site Disease Groups,
complementary therapies from the Courtelis Center, and education
and outreach events. Sylvester recently opened a satellite facility
in Kendall as well. http://www.sylvester.org
About Novelos Therapeutics, Inc.
Novelos Therapeutics, Inc. is a biopharmaceutical company
developing oxidized glutathione-based compounds for the treatment
of cancer. Our lead compound, NOV-002, has been administered to
approximately 1,000 cancer patients in clinical trials and is in
Phase 2 development for solid tumors in combination with
chemotherapy. Novelos is seeking to expand our pipeline through
licensing or acquiring clinical stage compounds or technologies for
oncology indications. For additional information about Novelos
please visit www.novelos.com
Novelos Therapeutics, Inc.
One Gateway Center, Suite 504
Newton, MA 02458
This news release contains forward-looking statements. Such
statements are valid only as of today, and we disclaim any
obligation to update this information. These statements 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.