BioSphere Medical Submits Investigational Device Exemption to FDA for QuadraSphere® Microspheres for Use with Doxorubicin fo...
27 Octubre 2009 - 5:30AM
Business Wire
BioSphere Medical, Inc. (NASDAQ:BSMD) (“BioSphere” or the
“Company”) – the leader in the use of bioengineered
microspheres to treat uterine fibroids, hypervascularized tumors
and vascular malformations by a minimally invasive, image-guided
medical procedure called embolotherapy – today announced the
submission to the U.S. Food and Drug Administration (FDA) of an
Investigational Device Exemption (IDE) application for a clinical
trial for the use of BioSphere’s QuadraSphere® Microsphere product
(QuadraSphere) to deliver the chemotherapeutic agent doxorubicin
for the treatment of primary liver cancer. Provided that the FDA
accepts the planned clinical protocol, the Company plans to begin
enrolling patients into the study within 60 days of FDA
approval.
The proposed investigation will be a prospective, randomized,
double-blinded clinical trial conducted at approximately 15 sites
in the U.S., European Union and Brazil. The clinical trial will
focus on treating patients with advanced hepatocellular carcinoma
(HCC), also known as primary liver cancer, and will compare
QuadraSphere with doxorubicin against conventional transarterial
chemoembolization (cTACE) with doxorubicin. BioSphere anticipates
that patient enrollment will take approximately 12 months, and that
it will file a premarket approval application (PMA) with the FDA
approximately 12 months after the final patient is enrolled. The
Company expects to fund trial costs from current working capital
and cash flow from operations.
Richard Faleschini, chief executive officer of BioSphere
Medical, said, “Only a small percentage, about 25%, of the more
than 600,000 patients diagnosed each year with hepatocellular
cancer worldwide can be treated with surgery or transplant. For the
majority of patients with hepatocellular cancer, conventional
transarterial chemoembolization (cTACE) is the standard of care. At
the present time, there is not an embolic in the United States with
FDA market clearance for the treatment of hepatocellular
cancer.”
Mr. Faleschini added, “Independent studies in Europe of our
embolic loaded with doxorubicin have generated positive results,
and the pivotal study is designed to further evaluate clinical
performance. The QuadraSphere with doxorubicin clinical trial is an
important milestone for BioSphere, and if the trial is successful
and the PMA is approved by the FDA, it is expected to be the first
FDA approval for hepatocellular carcinoma using chemoembolization,
providing further demonstration of our leadership position in
embolotherapy.”
About QuadraSphere Microspheres
QuadraSphere’s technical attributes are designed to provide a
unique and versatile embolization platform. Its spherical shape is
designed to allow for a predictable, flow-directed occlusion. The
product has been demonstrated to expand to four times its dry-state
diameter. Also, QuadraSphere is designed to afford atraumatic
conformability to the vessel architecture, leading to a more
complete vessel occlusion. QuadraSphere is technically identical to
BioSphere's HepaSphere™ Microspheres, an embolic currently CE
marked in the European Union for delivery of doxorubicin for
embolization of HCC and hepatic metastases.
About Conventional Transarterial Chemoembolization
(cTACE)
Conventional transarterial chemoembolization (cTACE) is a
two-stage process involving the injection of a concentrated dose of
chemotherapeutic drugs, e.g., doxorubicin, directly into the blood
vessels that feed a tumor, followed by the infusion of an embolic
agent through a catheter and into the blood vessels that feed a
tumor, thus selectively blocking the tumor’s blood supply. Because
the blood vessels are blocked with the embolic material, the
chemotherapeutic drug is thought to dwell in direct contact with
the tumor longer and target the tumor more effectively than would a
systemic chemotherapeutic treatment.
About BioSphere Medical, Inc.
BioSphere Medical, Inc. seeks to pioneer and commercialize
minimally invasive diagnostic and therapeutic applications based on
proprietary bioengineered microsphere technology. The Company's
core technologies, patented bioengineered polymers and
manufacturing methods are used to produce microscopic spherical
materials with properties that may be beneficial in a variety of
medical applications. BioSphere's principal focus is the treatment
of symptomatic uterine fibroids using a procedure called uterine
fibroid embolization, or UFE. The Company's products continue to
gain acceptance in this rapidly emerging procedure, as well as in a
number of other new and established medical treatments.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, including, without limitation, statements regarding the
Company’s planned clinical trials and FDA submissions for its
QuadraSphere Microsphere product and the expected benefits of
QuadraSphere for the treatment of primary liver cancer. The Company
may use words such as "plans," "seeks," "projects," "believes,"
"may," "anticipates," "estimates," "should," "intends," "looking
forward," and similar expressions to identify these forward-looking
statements. These statements are subject to risks and uncertainties
and are based upon the Company's beliefs and assumptions. There are
a number of important factors that may affect the Company's actual
performance and results and the accuracy of its forward-looking
statements, many of which are beyond the Company's control and are
difficult to predict. These important factors include, without
limitation, risks relating to:
- the failure of the Company to
successfully develop, commercialize and achieve widespread market
acceptance of its products, including, without limitation,
widespread market acceptance of its Embosphere® Microspheres for
the treatment of UFE, its HepaSphere™ Microsphere and QuadraSphere®
Microsphere products, and its delivery systems product line;
- the Company’s ability to obtain
FDA authorization to investigate the safety and efficacy of
QuadraSphere loaded with a chemotherapeutic agent for the treatment
of HCC; the failure to demonstrate safety or effectiveness in
clinical trials; or the failure to obtain PMA approval;
- the failure of the Company to
increase the rate of UFE procedures, and concomitant use of its
products for UFE, with its sales and marketing strategies;
- the failure of the Company to
achieve or maintain necessary regulatory approvals, either in the
United States or internationally, with respect to the testing,
manufacture and sale of its products and product candidates,
including, without limitation, the risk that the Company will not
gain necessary regulatory approvals to market and sell its products
in Japan through its agreement with Nippon Kayaku and that it will
not successfully advance its QuadraSphere clinical trials;
- the Company’s ability to obtain
and maintain patent and other proprietary protection for its
products and product candidates;
- the absence of, or delays or
cancellations of, product orders;
- delays, difficulties or
unanticipated costs in the introduction of new products;
- competitive pressures and the
risk of product liability claims, either of which may impact market
acceptance of products and adversely affect the Company’s operating
results;
- the inability of the Company to
successfully execute on its plans and strategies for future growth,
including its plans to grow its business in both the UFE and
interventional oncology fields and its plans for international
growth;
- the inability of the Company to
raise additional funds in the near term to finance the development,
marketing, and sales of its products;
- general economic and market
conditions, both domestic and abroad; and
- risk factors described in the
section titled "Risk Factors" in the Company's Annual Report on
Form 10-K for the year ended December 31, 2008 and for the Quarter
ended June 30, 2009, each as filed by the Company with the
Securities and Exchange Commission, and described in other filings
made by the Company from time to time with the Securities and
Exchange Commission.
In addition, the forward-looking statements included in this
press release represent the Company’s estimates as of the date of
this release. The Company anticipates that subsequent events and
developments may cause its forward-looking statements to change.
The Company specifically disclaims any obligation or intention to
update or revise these forward-looking statements as a result of
changed events or circumstances after the date of this press
release.
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