Sirtex Medical Inc. Half-Year Dose Sales Surge 28 Percent in Advance of SIRFLOX Primary Endpoint Announcement
February 18 2015 - 8:13AM
Business Wire
Sirtex Medical Inc., a subsidiary of Sirtex Medical Limited
(ASX:SRX), has announced that dose sales of SIR-Spheres® Y-90 resin
microspheres in the Americas region grew more than 28 percent for
the first half of the company’s fiscal year compared to the same
period last year, with 3,390 doses supplied for the period July
through December 2014. The gross sales in the region equate to
$54.3M in the first half of the current fiscal year compared to
$39.8M from the prior year, a 36.7% increase. Globally the company
announced sales of 4,950 doses, an increase of 26.3% over the
previous corresponding six-month period.
Increased awareness and customer education are key factors
contributing to these gains. The company continues to make
significant inroads with key referral groups in the oncology
community about the benefits of Selective Internal Radiation
Therapy (SIRT) while continuing to support the interventional
radiologists who perform the treatment. “The America’s region
continues to execute against our strategic initiatives. We have
achieved a number of significant milestones during this period
including enhanced oncology-related customer relationships in the
U.S. and approval in Brazil for the treatment of unresectable liver
tumors,” said Mike Mangano, president of Sirtex Medical Inc. “We
are eagerly awaiting SIRFLOX primary endpoint data, which we
believe will further validate our technology in the eyes of the
oncology community while helping to drive future growth.”
The SIRFLOX study is designed to evaluate whether
standard-of-care chemotherapy (FOLFOX6m with or without biological
therapy with bevacizumab) in combination with SIR-Spheres Y-90
resin microspheres is more effective than chemotherapy alone. This
is the first time that this combination of systemic and
liver-directed treatments has been assessed together as part of a
randomized controlled study in patients who have not been
previously treated. Primary endpoint data on this study, which
enrolled more than 500 patients, is expected in March preceding the
announcement of comprehensive study results at ASCO in late
May.
In January 2015 the company announced the completion of patient
enrolment for the FOXFIRE/FOXFIRE-GlobalTM study – an international
research study designed to evaluate a treatment option for patients
with colorectal cancer that have undergone metastatic spread to the
liver. The study is designed to evaluate whether FOLFOX
chemotherapy in combination with SIRT is more effective than
chemotherapy alone, with overall survival as the primary endpoint.
When complete and pooled with the SIRFLOX data, the company will
have long term survival data in more than 1,000 patients.
For more information visit www.Sirtex.com or find the latest
updates on the SIR-Spheres Y-90 resin microspheres Facebook page
(www.Facebook.com/SIRSpheresmicrospheres).
About Selective Internal Radiation Therapy using SIR-Spheres
microspheres
Selective Internal Radiation Therapy (SIRT), also known as
radioembolization, is a proven technology for inoperable liver
cancer that delivers doses of radiation directly to the site of
tumors. In a minimally invasive treatment, millions of radioactive
SIR-Spheres Y-90 resin microspheres are infused via a catheter into
the liver where they selectively target liver tumors with a dose of
internal radiation up to 40 times higher than conventional
radiotherapy, while sparing healthy tissue.
Clinical studies have confirmed that patients with metastatic
colorectal cancer treated with SIR-Spheres Y-90 resin microspheres
have response rates higher than with other forms of treatment,
resulting in increased life expectancy, greater periods without
tumor activity and improved quality of life. SIRT has been found to
shrink liver tumors more than chemotherapy alone.
In the U.S., SIR-Spheres Y-90 resin microspheres are indicated
for the treatment of unresectable metastatic liver tumors from
primary colorectal cancer with adjuvant intra-hepatic artery
chemotherapy (IHAC) of FUDR (Floxuridine). SIR-Spheres Y-90 resin
microspheres are approved for use in Argentina, Brazil, Australia,
the European Union and several countries in Asia for the treatment
of unresectable liver tumors.
Available at more than 400 treatment centers in the U.S.,
approximately 50,000 doses of SIR-Spheres Y-90 resin microspheres
have been supplied worldwide.
For more information, visit www.sirtex.com.
SIR-Spheres® is a registered trademark of
Sirtex SIR-Spheres Pty Ltd.
For Sirtex Medical Inc.Elizabeth Romero,
919-457-0749elizabeth.romero@fleishman.com
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