OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) announced today the
initiation of two clinical trials with OSI-906, the Company’s
potential first-in-class, oral insulin-like growth factor-1
receptor (IGF-1R) inhibitor. The first study is a Phase III,
multi-center study that will evaluate the use of OSI-906 for
patients with locally advanced or metastatic adrenocortical
carcinoma (ACC). The study is designed to determine overall
survival for patients receiving single-agent OSI-906 versus placebo
and will also evaluate progression free-survival, disease control
rate, overall response rate as well as safety. The second study is
a Phase I/II trial evaluating OSI-906 in combination with the
chemotherapy paclitaxel (Taxol®), primarily in patients with
recurrent epithelial ovarian cancer.
“Data from our Phase I program for OSI-906
show encouraging evidence of anti-tumor activity,
particularly in adrenocortical carcinoma. We are pleased to
initiate a Phase III trial in this underserved patient
population where the only approved therapy is Mitotane, a
cytotoxic derivative of the pesticide DDT,” said Colin Goddard,
Chief Executive Officer, OSI Pharmaceuticals.
OSI-906 is a potent inhibitor of IGF-1R which has been viewed as
an important therapeutic target due to its involvement in the
growth and proliferation of a variety of human cancers, including
ACC, ovarian and non-small cell lung (NSCLC) cancers. IGF-1 and
IGF-2 are growth factors, or hormones, know to stimulate growth and
survival of cancerous cells. The likely tie-in of IGF-2
over-expression as a strong driver of tumor signaling in ACC -
where it is over-expressed in approximately 90% of patients - and
also in ovarian cancer provided the rationale for the
Company's decision to aggressively pursue these indications.
In addition, OSI intends to initiate a registration-oriented
combination study of OSI-906 with Tarceva® (erlotinib) in NSCLC.
Initial indications of monotherapy activity for OSI-906 in
NSCLC and our translational research data suggesting
that compensatory signaling mechanisms and
epithelial-mesenchymal transition (EMT) phenomena may make a
combination of Tarceva and OSI-906 synergistically effective in the
NSCLC setting provide the rationale for this clinical
trial which is intended to begin in 2010.
About the Phase III ACC
Trial
The Phase III trial is a multi-center, randomized, double-blind,
placebo-controlled study and is expected to enroll approximately
135 patients with locally advanced or metastatic ACC. Patients with
ACC who received at least one but no more than two prior drug
regimens will be randomized 2:1 (90 patients in OSI-906 arm; 45
patients in the placebo arm) to receive either single agent OSI-906
at 150mg BID (2 times a day) or placebo. Patients must have
received a prior Mitotane containing regimen.
The study will examine whether OSI-906 prolongs survival
compared to placebo. The primary endpoint of the study is overall
survival and the secondary endpoints include progression
free-survival, disease control rate, overall response rate as well
as safety. A planned interim analysis of efficacy will occur
several months following the completion of accrual. The study will
be conducted at approximately 45 sites worldwide including the
United States, Europe, Brazil, Israel, and Australia.
OSI will apply for orphan drug status in the adrenocortical
carcinoma setting. Orphan drug designation, when granted by the
FDA's Office of Orphan Products Development, allows for up to seven
years of marketing exclusivity after gaining FDA approval, as well
as clinical study incentives, study design assistance, waivers of
certain FDA user fees, and potential tax credits.
About the Phase I/II
OvarianTrial
The Phase I/II trial is a multi-center, randomized, open-label
study evaluating intermittent and continuous OSI-906 and weekly
paclitaxel in patients with recurrent epithelial ovarian cancer and
other solid tumors. Approximately 169 patients will be treated in
the study; up to 40 patients in the Phase I portion and up to 129
patients in the randomized Phase II portion.
The Phase I dose escalation of the study will establish the
maximum tolerated dose (MTD) of intermittent and continuous OSI-906
in combination with weekly paclitaxel in patients with advanced
solid tumors. The Phase II study will begin after the recommended
dose has been established. The Phase II study will enroll
patients with relapsed/recurrent epithelial ovarian cancer and will
be randomized 1:1:1 to three treatment groups. Arm A will include
intermittent OSI-906 QD (once a day) on days 1-3, 8-10, and 15-17
with paclitaxel on days 1, 8, and 15; Arm B will include continuous
OSI-906 BID (2 times a day) from day 1 onwards with paclitaxel on
days 1, 8, and 15; and Arm C will include paclitaxel on days 1, 8,
and 15.
The primary objective of this study is to evaluate in parallel
the anti-tumor efficacy as determined by CA125 response rate of two
different schedules of OSI-906 in combination with weekly
paclitaxel in recurrent/refractory ovarian cancer patients.
For more information about enrolling in either of these studies,
please visit www.clinicaltrials.gov.
About Adrenocortical
Carcinoma
Adrenocortical carcinoma (ACC) is a disease in which malignant
(cancer) cells form in the outer layer of the adrenal gland. ACC is
a rare disease with an estimated incidence of one to two cases per
million in adults. Additionally, ACC is characterized by a high
risk of recurrence after radical resection, and whether the use of
current treatment is beneficial as an adjuvant treatment has been
controversial.
About Ovarian
Cancer
Ovarian cancer is the eighth most common cancer among women,
excluding non-melanoma skin cancers. The American Cancer Society
estimates that about 21,550 new cases of ovarian cancer will be
diagnosed in the United States during 2009. Ovarian cancer accounts
for about 3% of all cancers in women. Ovarian cancer ranks fifth in
cancer deaths among women, accounting for more deaths than any
other cancer of the female reproductive system. It is estimated
that there will be about 14,600 deaths from ovarian cancer in the
United States during 2009. In Europe, an estimated 61,000 new cases
are diagnosed each year, and the annual death rate due to ovarian
cancer is 39,000.
About OSI
Pharmaceuticals
OSI Pharmaceuticals is committed to "shaping medicine and
changing lives" by discovering, developing and commercializing
high-quality, novel and differentiated targeted medicines designed
to extend life and improve the quality of life for patients with
cancer and diabetes/obesity. For additional information about OSI,
please visit http://www.osip.com.
This news release contains forward-looking statements. 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. Factors that might cause such
a difference include, among others, OSI's and its collaborators'
abilities to effectively market and sell Tarceva and to expand the
approved indications for Tarceva, OSI’s ability to protect its
intellectual property rights, safety concerns regarding Tarceva,
competition to Tarceva and OSI’s drug candidates from other
biotechnology and pharmaceutical companies, the completion of
clinical trials, the effects of FDA and other governmental
regulation, including pricing controls, OSI's ability to
successfully develop and commercialize drug candidates, and other
factors described in OSI Pharmaceuticals' filings with the
Securities and Exchange Commission.
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