FYI to All from Barry Sugarman:
October 23, 2007 -- Nutley N.J.
Roche Announces Positive Results in Solid Tumors Using Human Monoclonal
Antibody against IGF-1R (R1507)
Today, Roche announced positive results from a Phase I trial of R1507, a
human monoclonal antibody to target IGF-1R (insulin-like growth factor
receptor), in patients with solid tumors. IGF-1 is one of the most potent
natural activators of the AKT and MAPK signaling pathways, which promote
cell growth and cell survival. The IGF-1R pathway has also been shown to
have an important role in mediating the resistance to cytotoxic drugs and
EGFR/HER2-targeted agents. The results were reported during the
AACR-NCI-EORTC International Conference on Molecular Targets and Cancer
Therapeutics, held in San Francisco.
Study Results
In the Phase I study, R1507 was administered by intravenous infusion. Nine
of 34 adult patients with advanced solid tumors experienced disease
stabilization. Four of the seven heavily pretreated patients with Ewing's
sarcoma demonstrated clinical benefit with two of these patients achieving
durable, objective partial responses.
Once a week administration of R1507 was well tolerated with very few side
effects. Treatment with R1507 was not associated with the typical
side-effects normally observed with cancer therapy (e.g., low blood
counts, infection, hair loss, severe nausea and vomiting). The most
frequent side effects observed were fatigue, anorexia and weight loss,
symptoms that are commonly observed in patients with advanced cancer.
"We are very encouraged by these early results with R1507 in patients
with refractory Ewing's sarcoma," said Kapil Dhingra, MD, Head, Oncology
Disease Biology Area at Roche. "As a result, we have given this program a
very high priority as we believe this molecule has the potential to be
very beneficial in treating patients with sarcoma as well as a variety of
other solid tumors."
The antibody (R1507) was initially developed under Roche's broad antibody
development collaboration with Genmab, which began in 2001.
The Phase I study is being conducted at four sites in the U.S., including
the University of Colorado Cancer Center (Aurora, CO), The University of
Texas M.D. Anderson Cancer Center (Houston, TX), Cancer Institute of New
Jersey (New Brunswick, NJ) and The Institute for Drug Development (San
Antonio, TX). R1507 has also been investigated in 26 patients on a three
week schedule in the Phase I study. This treatment schedule was also
generally well tolerated with a side effect profile similar to the weekly
schedule.
"This drug attacks the IGF pathway and may provide a new class of drugs to
treat a variety of cancers, including breast, prostate, colon, melanoma,
myeloma and a variety of sarcomas, which could greatly add to the way that
we currently treat these patients," says Stephen Leong, M.D., assistant
professor of Medical Oncology at the University of Colorado Cancer Center
and lead author of the abstract.
Razelle Kurzrock, MD, investigator at the M.D. Anderson Cancer Center and
the senior author of the abstract, noted that some of the responses were
very impressive. For instance, one 28 year-old Ewing's sarcoma patient
with large tumors unresponsive to many other treatments showed dramatic
tumor shrinkage within six weeks, without side effects. "This is one of
the best responses I've seen in over 20 years of oncology experience,"
stated Dr. Kurzrock.
Based on these initial results with R1507, Roche plans to conduct
additional trials and work with a global consortium of sarcoma experts,
including the Sarcoma Alliance for Research through Collaboration (SARC).
"We are very excited about our collaboration with SARC, which represents a
new approach to sarcoma clinical trials, and we look forward to combining
our expertise with that our colleagues at SARC to expedite new sarcoma
treatments," added Dhingra.
"We are excited to be partnering with Roche on the development of a new
treatment against an important target, which could result in a potential
breakthrough treatment for sarcoma as well as other cancers," said
Laurence Baker, DO, professor of Medicine and Pharmacology at the
University of Michigan and the Executive Director, SARC. "With Roche's
considerable expertise in oncology and SARC's vast network of physicians
and institutions, we look forward to determining the potential of R1507 in
this important disease area."
About Ewing's Sarcoma
The Ewing's family of tumors (EFT) includes primary tumors of bone
(classic Ewing's sarcoma, primitive neuroectodermal tumor, and Askin
tumor) and extraosseous primary tumors {National Cancer Institute}.
Studies using immunohistochemical markers, cytogenetics, molecular
genetics, and tissue culture indicate that these tumors are all derived
from the same primordial stem cell. EFTs account for 4 percent of
childhood and adolescent malignancies. The estimated incidence (US) is
approximately 300 new cases per year. The median age for patients with EFT
is 15 years and more than 50 percent of patients are adolescents. There is
a slight male predominance and the lower limbs are affected in 40 percent
of the patients.
Approximately 20 to 30 percent of the patients with ETB have overt
metastases at the time of diagnosis. However, outcomes for patients with
metastatic disease have improved little during the last 20 years.
Approximately 25-30 percent survival could be achieved with current
therapies for patients who present with metastatic disease at initial
diagnosis.
About Roche
Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S.
pharmaceuticals headquarters of the Roche Group, one of the world's
leading research-oriented healthcare groups with core businesses in
pharmaceuticals and diagnostics. For more than 100 years in the U.S.,
Roche has been committed to developing innovative products and services
that address prevention, diagnosis and treatment of diseases, thus
enhancing people's health and quality of life. An employer of choice, in
2007 Roche was named Top Company of the Year by Med Ad News and one of the
Top 20 Employers (Science magazine). In 2006, Roche was ranked the No.
1 Company to Sell For (Selling Power), and one of AARP's Top Companies for
Older Workers, and in 2005, Roche was named one of Fortune magazine's Best
Companies to Work For in America. For additional information about the
U.S. pharmaceuticals business, visit our websites: http://www.rocheusa.com
or www.roche.us.
About SARC
The purpose of the Sarcoma Alliance for Research through Collaboration
(SARC) is to engage all appropriate and necessary resources to cure and
prevent sarcoma. SARC brings together expert sarcoma researchers and
clinicians from 29 centers of excellence in the United States. SARC by
the charter, promotes international collaboration in sarcoma clinical
trials through is association with European sarcoma experts. SARC is
unique as a clinical trial organization in that its trials at the
inception include pediatric and medical patients with sarcoma, because
sarcomas affect people of all ages. SARC is a 501c3, non-profit
organization that is headquartered in Ann Arbor, Michigan.
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Contacts: 973-562-2699