Novelos Therapeutics Announces Continued Encouraging Results in Ongoing Phase 2 Ovarian...
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Novelos Therapeutics Announces Continued Encouraging Results in Ongoing Phase 2 Ovarian Cancer Trial at Dana-Farber/Harvard Cancer Center
Data Accepted for Poster Presentation at ASCO 2008
NEWTON, Mass.--(Business Wire)--
Novelos Therapeutics, Inc. (OTCBB: NVLT), a biopharmaceutical
company focused on the development of therapeutics to treat cancer and
hepatitis, today announced continued encouraging results in an ongoing
Massachusetts General Hospital Cancer Center and Dana-Farber/Harvard
Cancer Center (DF/HCC) Phase 2 trial of NOV-002 in combination with
carboplatin in platinum-resistant ovarian cancer patients. Fifteen
patients have now been enrolled and, to date, 60% (9) have had slower
than expected disease progression. NOV-002 was well-tolerated, further
extending the excellent safety profile NOV-002 has demonstrated in
previous studies.
Detailed results of this trial will be presented as a poster at
the 2008 annual meeting of the American Society of Clinical Oncology
(ASCO) taking place May 30 - June 3 in Chicago, Illinois.
"I am encouraged by these results in platinum-resistant ovarian
cancer, with NOV-002 (in combination with carboplatin) apparently
slowing disease progression in over half of the treated patients. Most
women who have failed three lines of chemotherapy would be expected to
progress in about eight weeks. I am excited to present the trial
results at ASCO," said Dr. Carolyn Krasner, medical oncologist at the
Massachusetts General Hospital Cancer Center and the Principal
Investigator.
"We look forward to working closely with Dr. Krasner, the
Massachusetts General Hospital Cancer Center, Dana-Farber/Harvard and
other institutions on designing and implementing a larger NOV-002
trial for this indication," said Harry Palmin, President and CEO of
Novelos. "Our objective is to commence the next Phase 2 trial in
platinum-resistant ovarian cancer in early 2009."
According to the American Cancer Society, in 2007 approximately
22,000 U.S. women were diagnosed with ovarian cancer and 15,000 women
were expected to die from it. There is a lack of effective treatment,
particularly in the case of platinum-resistant patients. Once a
woman's ovarian cancer is defined as platinum-resistant the chance of
having a partial or complete response to further platinum therapy is
typically less than 10% and only 10-20% with other available agents.
Thus, there is a major unmet medical need for this indication.
About Massachusetts General Hospital Cancer Center
An integral part of one of the world's most distinguished medical
centers, the Massachusetts General Hospital Cancer Center is chosen by
more cancer patients than any other hospital in New England. Its
commitment to eradicating cancer is fueled by scientific investigation
conducted as part of the largest hospital-based research program in
the United States. The Cancer Center fosters innovation in basic,
translational and clinical research. It is a founding member of the
DF/HCC, a Harvard Medical School consortium designated by the National
Cancer Institute as a comprehensive cancer center. This prestigious
seven-member center comprises the largest research collaboration in
the country. Also, through the DF/HCC partnership, the Cancer Center
and Dana-Farber/Brigham & Women's Cancer Center collaborate on joint
clinical trials, education, training programs and quality of care
improvements.
About Dana-Farber/Harvard Cancer Center (DF/HCC)
DF/HCC is a joint venture non-profit consortium established by
Dana-Farber Cancer Institute, the Harvard Medical School and Harvard
School of Medicine and Public Health, and the Beth Israel Deaconess,
Brigham and Women's, Children's, and Massachusetts General hospitals.
The clinical research efforts of this consortium are organized through
Disease Programs. The Gynecologic Cancer Program focuses on the
evaluation of novel therapeutic strategies in the treatment of women
with gynecologic malignancies and in particular ovarian cancer.
About Novelos Therapeutics, Inc.
Novelos Therapeutics, Inc. is a biopharmaceutical company
commercializing oxidized glutathione-based compounds for the treatment
of cancer and hepatitis. NOV-002, the lead compound currently in Phase
3 development for lung cancer under a SPA and Fast Track, acts
together with chemotherapy as a chemoprotectant and an
immunomodulator. NOV-002 is also in Phase 2 development for
chemotherapy-resistant ovarian cancer and early-stage breast cancer.
NOV-205 acts as a hepatoprotective agent with immunomodulating and
anti-inflammatory properties. NOV-205 is in Phase 1b development for
chronic hepatitis C non-responders. Both compounds have completed
clinical trials in humans and have been approved for use in the
Russian Federation where they were originally developed. For
additional information about Novelos please visit www.novelos.com.
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.
Novelos Therapeutics, Inc.
Company
Harry S. Palmin, 617-244-1616 x11
President and CEO
hpalmin@novelos.com
or
Investor Relations
Stephen Lichaw, 201-240-3200
slichaw@novelos.com
Copyright Business Wire 2008
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