COLLEGEVILLE, Pa., May 30 /PRNewswire-FirstCall/ -- Wyeth
Pharmaceuticals, a division of Wyeth (NYSE: WYE), today announced the
initiation of the INTORACT (INvestigation of TORISEL and Avastin
Combination Therapy) study, a worldwide randomized, open-label, phase 3b
study comparing TORISEL(R) (temsirolimus) plus Avastin(R) (bevacizumab)
versus Avastin plus interferon-alfa for first-line treatment of patients
with advanced renal cell carcinoma (RCC). Wyeth Research is conducting the
INTORACT study with the support and assistance of Roche and Genentech.
"Several therapies have been introduced in the past few years that have
led to improvements in the way we treat advanced kidney cancer," says
Joseph S. Camardo, M.D., Senior Vice President, Global Medical Affairs,
Wyeth Pharmaceuticals. "In the INTORACT study, we hope to learn more about
whether combining TORISEL with other agents in the first-line setting may
further improve outcomes for patients with this devastating disease."
The primary end point of the INTORACT study is independently assessed
progression-free survival (PFS) of patients in all risk groups. Secondary
end points include safety, investigator-assessed PFS, independently
assessed objective response rate (complete response plus partial response)
and overall survival.
A treatment regimen combining the mTOR (mammalian target of rapamycin)
inhibitor TORISEL with the vascular endothelial growth factor (VEGF)
inhibitor Avastin was shown in a phase 1/2 trial of patients with stage IV
renal cancer to have an acceptable safety profile and supported further
investigation in a phase 3 study.
"We hope to learn whether a regimen that combines the angiogenesis
inhibition of bevacizumab with the mTOR inhibition of temsirolimus may
provide further evidence of clinical utility in advanced RCC," says Brian
Rini, M.D., of the Cleveland Clinic Taussig Cancer Institute in Cleveland,
and co-principal investigator of INTORACT.
RCC will account for approximately 85 percent of the estimated 54,390
new cases of kidney cancer that will be diagnosed in the United States
annually, and about 40 percent of these patients will have advanced disease
at the time of diagnosis. Clear-cell RCC accounts for about 75 percent of
all RCC cases.
Wyeth is conducting a number of studies examining TORISEL in various
settings. Additional information about TORISEL studies is available at
http://www.clinicaltrials.gov.
About TORISEL
TORISEL is the only approved cancer therapy that specifically inhibits
the mTOR kinase, an important regulator of cell proliferation, cell growth
and cell survival. Inhibition of mTOR in treated cancer cells blocked the
translation of genes that regulate the cell cycle. In in vitro studies
using renal cancer cell lines, TORISEL inhibited the activity of mTOR and
resulted in reduced levels of certain cell growth factors involved in the
development of new blood vessels, such as vascular endothelial growth
factor.
TORISEL is approved for the treatment of advanced RCC in the United
States, European Union and other markets, based on results of a phase 3
clinical study that demonstrated that TORISEL improves overall survival for
patients with advanced RCC compared with interferon-alfa.
Important Safety Information
Hypersensitivity reactions manifested by symptoms, including, but not
limited to anaphylaxis, dyspnea, flushing, and chest pain have been
observed with TORISEL. Serum glucose, serum cholesterol, and triglycerides
should be tested before and during treatment with TORISEL. The use of
TORISEL is likely to result in hyperglycemia and hyperlipemia. This may
result in the need for an increase in the dose of, or initiation of,
insulin and/or oral hypoglycemic agent therapy and/or lipid-lowering
agents, respectively.
The use of TORISEL may result in immunosuppression. Patients should be
carefully observed for the occurrence of infections, including
opportunistic infections. Cases of interstitial lung disease, some
resulting in death, have occurred. Some patients were asymptomatic and
others presented with symptoms. Some patients required discontinuation of
TORISEL and/or treatment with corticosteroids and/or antibiotics. Cases of
fatal bowel perforation occurred with TORISEL. These patients presented
with fever, abdominal pain, metabolic acidosis, bloody stools, diarrhea,
and/or acute abdomen. Cases of rapidly progressive and sometimes fatal
acute renal failure not clearly related to disease progression occurred in
patients who received TORISEL.
Due to abnormal wound healing, use TORISEL with caution in the
perioperative period. Patients with central nervous system tumors (primary
CNS tumor or metastases) and/or receiving anticoagulation therapy may be at
an increased risk of developing intracerebral bleeding (including fatal
outcomes) while receiving TORISEL. Live vaccinations and close contact with
those who received live vaccines should be avoided. Patients and their
partners should be advised to avoid pregnancy throughout treatment and for
3 months after TORISEL therapy has stopped.
The most common (incidence greater than or equal to 30%) adverse
reactions observed with TORISEL are: rash (47%), asthenia (51%), mucositis
(41%), nausea (37%), edema (35%), and anorexia (32%). The most common
laboratory abnormalities (incidence greater than or equal to 30%) are
anemia (94%), hyperglycemia (89%), hyperlipemia (87%), hypertriglyceridemia
(83%), elevated alkaline phosphatase (68%), elevated serum creatinine
(57%), lymphopenia (53%), hypophosphatemia (49%), thrombocytopenia (40%),
elevated AST (38%), and leukopenia (32%). Most common grades 3/4 adverse
events included asthenia (11%), dyspnea (9%), hemoglobin decreased (20%),
lymphocytes decreased (16%), glucose increased (16%), phosphorus decreased
(18%), and triglycerides increased (44%).
Strong inducers of CYP3A4/5 (e.g., dexamethasone, rifampin) and strong
inhibitors of CYP3A4 (e.g., ketoconazole, atazanavir) may decrease and
increase concentrations of the major metabolite of TORISEL, respectively.
If alternatives cannot be used, dose modifications of TORISEL are
recommended. St. John's Wort may decrease TORISEL plasma concentrations,
and grapefruit juice may increase plasma concentrations of the major
metabolite of TORISEL, and therefore both should be avoided. The
combination of TORISEL and sunitinib resulted in dose-limiting toxicity
(Grade 3/4 erythematous maculopapular rash, and gout/cellulitis requiring
hospitalization).
Please see TORISEL full Prescribing Information at
http://www.TORISEL.com.
Wyeth Pharmaceuticals
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the
areas of women's health care, infectious disease, gastrointestinal health,
central nervous system, inflammation, transplantation, hemophilia,
oncology, vaccines and nutritional products.
Wyeth is one of the world's largest research-driven pharmaceutical and
health care products companies. It is a leader in the discovery,
development, manufacturing and marketing of pharmaceuticals, vaccines,
biotechnology products, nutritionals and non-prescription medicines that
improve the quality of life for people worldwide. The Company's major
divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort
Dodge Animal Health.
The statements in this press release that are not historical facts are
forward-looking statements that are subject to risks and uncertainties that
could cause actual results to differ materially from those expressed or
implied by such statements. These risks and uncertainties include, without
limitation, the inherent uncertainty of the timing and success of, and
expense associated with, research, development, regulatory approval and
commercialization of our products and pipeline products; government cost-
containment initiatives; restrictions on third-party payments for our
products; substantial competition in our industry, including from branded
and generic products; emerging data on our products and pipeline products;
the importance of strong performance from our principal products and our
anticipated new product introductions; the highly regulated nature of our
business; product liability, intellectual property and other litigation
risks and environmental liabilities; uncertainty regarding our intellectual
property rights and those of others; difficulties associated with, and
regulatory compliance with respect to, manufacturing of our products; risks
associated with our strategic relationships; economic conditions including
interest and currency exchange rate fluctuations; changes in generally
accepted accounting principles; trade buying patterns; the impact of
legislation and regulatory compliance; risks and uncertainties associated
with global operations and sales; and other risks and uncertainties,
including those detailed from time to time in our periodic reports filed
with the Securities and Exchange Commission, including our current reports
on Form 8-K, quarterly reports on Form 10-Q and annual report on Form 10-K,
particularly the discussion under the caption "Item 1A, Risk Factors" in
our Annual Report on Form 10-K for the year ended December 31, 2007, which
was filed with the Securities and Exchange Commission on February 29, 2008.
The forward-looking statements in this press release are qualified by these
risk factors. We assume no obligation to publicly update any
forward-looking statements, whether as a result of new information, future
developments or otherwise.
Note to editors:
Dr. Rini is a paid consultant for Wyeth Pharmaceuticals.
SOURCE Wyeth Pharmaceuticals
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Related links:
http://www.wyeth.com
http://www.TORISEL.com
CONTACT:
Media - Danielle Halstrom of Wyeth
Pharmaceuticals, +1-484-865-2020, Mobile: +1-215-280-3898, or
Douglas Petkus of Wyeth, +1-973-660-5218; or Investor - Justin
Victoria of Wyeth, +1-973-660-5340
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