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Novelos Therapeutics Announces Positive Phase 2 Results in NOV-002 Neoadjuvan
t Breast Cancer Trial at Sylvester Comprehensive Cancer Center, at the Universit
y of Miami ( BusinessWire )

NEWTON, Mass., Jul 12, 2010 (BUSINESS WIRE) --
Novelos Therapeutics, Inc. (OTCBB: NVLT), a biopharmaceutical
company developing therapeutics to treat cancer and hepatitis, today
announced 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, conducted by the Braman
Family Breast Cancer Institute at Sylvester Comprehensive Cancer Center
at the University of Miami Miller School of Medicine. Alberto Montero,
MD, Assistant Professor of Medicine at the Miller School and medical
oncologist at Sylvester, is the Principal Investigator.

This Phase 2 open-label, single-arm, Simon 2-Stage 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. For NOV-002 to be declared
active at the end of the trial, a minimum of 12 patients must achieve a
pCR. This criterion of 12 pCRs has been met prior to all patients
completing the trial. Patient enrollment continues and some patients
are
still in the NOV-002 treatment stage. Trial results have been submitted
for presentation to the AACR Breast Cancer Symposium taking place in
San
Antonio, TX, in December 2010. 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 39 breast cancer patients have been enrolled
from three different hospitals we have 12 confirmed pathologic complete
responses out of 31 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%. We also continue to
observe very high pCR rates in the breast cancer subtype least
sensitive
to chemotherapy, hormone receptor positive breast cancer, also known as
luminal subtype, thus far we have confirmed pCR in approximately 11/26
(42%) of all ER+ pts. These results I believe provide preliminary data
that further trials of NOV-002 plus chemotherapy in breast cancer are
warranted."

"We are very pleased that NOV-002 has demonstrated positive results in
this Phase 2 neoadjuvant breast cancer trial," said Harry Palmin,
President and CEO of Novelos. "We look forward to working with Dr.
Montero, Sylvester Comprehensive Cancer Center, as well as key opinion
leaders and the FDA on a design for a possible larger randomized
controlled trial in breast cancer."

"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."

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 -- the University of Miami Health
System. Sylvester handles nearly 1,600 inpatient admissions annually,
performs 2,700 surgical procedures, and treats more than 3,700 new
cancer patients. All Sylvester physicians 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 more than $36 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. A major
expansion has recently been completed. Deerfield Beach offers
appointments with nearly 30 physicians from 12 of Sylvester's 15 Site
Disease Groups, complementary therapies from the Courtelis Center, and
education and outreach events. www.sylvester.org

About Novelos Therapeutics, Inc.

Novelos Therapeutics, Inc. is a biopharmaceutical company developing
oxidized glutathione-based compounds for the treatment of cancer and
hepatitis. 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.

SOURCE: Novelos Therapeutics
COMPANY
Novelos Therapeutics, Inc.
Harry S. Palmin, 617-244-1616 x11
President and CEO
Email: [e-mail]
or
INVESTOR RELATIONS
Stephen Lichaw, 201-240-3200
Email: [e-mail]
Copyright Business Wire 2010
*** end of story ***

[GKN]

Vieleicht langsam die Wende zum besseren..

[desertwolf01]

Antwort auf Beitrag Nr.: 39.810.683 von GKN am 13.07.10 06:55:04

Wie schon im anderen Thread geschrieben, man sollte hier beachten, dass diese Ergebnisse aus den USA stammen und nicht aus Russland oder irgenwelchen anderen Ländern, das ist diesmal wichtig !

[TinoTeletabbi]

Antwort auf Beitrag Nr.: 39.811.718 von desertwolf01 am 13.07.10 10:34:59

Also ich habe es verstanden!