Rolapitant is a Neurokinin-1 (NK-1) Receptor Antagonist in Development for Chemotherapy Induced Nausea and Vomiting (CINV)
Rolapitant Will Be Developed and Commercialized by TESARO Under License from OPKO
Each of the HEC clinical trials consist of approximately 530 patients and is focused on evaluating rolapitant plus the standard of care compared with placebo plus the standard of care. The MEC clinical trial consists of approximately 1,350 patients and is focused on evaluating rolapitant plus the standard of care compared with placebo plus the standard of care. In each of the Phase 3 clinical trials the standard of care consists of a 5-HT3 receptor antagonist in combination with the corticosteroid dexamethasone.
The patients in these clinical trials are being evaluated for evidence of an improvement in control of nausea and vomiting during the acute (0 — 24 hours), delayed (24 — 120 hours) and overall (0 — 120 hours) time periods post administration of chemotherapy. The primary outcome of each trial will be based on complete response (defined as no emetic episodes and no use of rescue medication) in the delayed phase. Additional outcome measures include complete response for other time points, the incidence and severity of nausea, and safety and tolerability. Results from each of the clinical trials are anticipated in the second half of 2013.
Rolapitant, a potent and selective neurokinin-1 (NK-1) receptor antagonist with an extended plasma half-life, is currently in Phase 3 clinical testing for prevention of chemotherapy induced nausea and vomiting (CINV). Phase 2 testing in cancer patients treated with highly emetogenic chemotherapy demonstrated promising five-day activity in CINV prevention following the administration of a single dose. The safety and tolerability of single and repeat doses of rolapitant has been assessed in over 1,000 subjects. Rolapitant is an investigational agent and has not been approved by regulatory agencies.
About Chemotherapy Induced Nausea and Vomiting (CINV)
CINV, if not prevented by prophylaxis, has the potential to afflict up to 90% of cancer patients undergoing chemotherapy, depending upon the type of chemotherapy administered, the dosing schedule of the chemotherapy and the patients' age and gender, among other predisposing factors. Prolonged nausea and vomiting may result in unwanted weight loss, dehydration and malnutrition as well as hospitalization. If not prevented, CINV may result in a delay or even discontinuation of chemotherapy treatment.
NK-1 receptors are highly concentrated in the brain and bind the neurokinin substance P. Activation of NK-1 receptors plays a central role in nausea and vomiting induced by emetogenic stimuli, including certain cancer chemotherapies. NK-1 receptor antagonists have been demonstrated to improve the management of nausea and vomiting experienced by cancer patients undergoing chemotherapy.
OPKO is a multi-national biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large and rapidly growing medical markets by leveraging its discovery, development and commercialization expertise and novel and proprietary technologies.
Forward Looking Statements:
Any statements that are not historical facts contained in this
release are "forward-looking statements" as that term is defined under
the Private Securities Litigation Reform Act of 1995 (PSLRA), which
statements may be identified by words such as "expects," "plans,"
"projects," "will," "may," "anticipates," "believes," "should,"
"intends," "estimates," and other words of similar meaning, including
statements regarding expectations about the enrollment in and outcome of
the clinical trials for rolapitant, the expected timing thereof,
TESARO's ability to successfully develop and commercialize rolapitant
for CINV, and the expected benefits of rolapitant in managing the nausea
and vomiting experienced by cancer patients undergoing chemotherapy.
Many factors could cause our actual activities or results to differ
materially from the activities and results anticipated in
forward-looking statements. These factors include those described in
OPKO's filings with the
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