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IMMEDIATE
RELEASE
CONTACTS:
Brent
Larson,
Vice
President / CFO
614
822 2330
|
January
11, 2010
Tim
Ryan,
The
Shoreham Group
212
242 7777
|
NEOPROBE
FILES CLINICAL PACKAGE FOR RIGS TECHNOLOGY WITH FDA
Phase
3 Clinical Trial Design Filed Under Special Protocol Assessment
DUBLIN,
OHIO – January 11, 2010 – Neoprobe Corporation (OTCBB: NEOP), a diversified
developer of innovative oncology surgical and diagnostic products, announced
today that it has submitted an investigational new drug (IND) amendment to the
United States Food and Drug Administration (FDA) which includes the design of a
proposed Phase 3 clinical trial of Neoprobe’s RIGScan® CR
radiopharmaceutical. RIGScan CR is designed to identify and evaluate potentially
tumor-associated tissue in patients with colon or rectal cancer. The IND
amendment includes a Special Protocol Assessment (SPA) in accordance with the
Prescription Drug User Fee Act of 1992 (PDUFA) and current regulatory
guidelines, and will be registered on www.clincaltrials.gov
following discussions with FDA regarding the SPA.
The Phase
3 clinical study as currently designed would be a randomized clinical study that
would evaluate the ability of RIGScan CR to identify tumor-associated tissue in
a group of patients as compared to a group of patients provided with traditional
surgical care. The sample size of the proposed Phase 3 clinical study has been
estimated at approximately 250 patients including both the RIGScan CR and
traditional treatment groups. In addition to assessing the ability of RIGScan CR
to identify tumor-associated tissue, the overall survival of the RIGScan CR
treated patients will be compared to the patients treated with conventional
treatment modalities.
“The
identification of tumor-associated tissue in cancer patients through the use of
biomarkers is of increasing clinical interest and importance,” said Dr. Fred
Cope, Neoprobe’s Vice President, Pharmaceutical Research and Clinical
Development. “RIGScan CR provided indications in earlier clinical studies that
it could identify potentially tumor-associated tissue and that the removal of
such tissue might improve patient outcomes. The objective of the proposed Phase
3 trial is to confirm those findings,” concluded Dr. Cope.
“The
filing of the SPA request follows our successful discussions with the
centralized European regulatory authorities (the EMEA) under their Scientific
Advice process,” said David Bupp, Neoprobe’s President and CEO. “Dr. Cope and
his team have completed an extensive scientific literature evaluation to support
the design of the Phase 3 study and we initiated the biologic development
activities to support the proposed Phase 3 study in 2009. The commencement of an
evaluation of the Phase 3 study design under the SPA provisions is an important
step in the development of RIGScan CR. The proposed trial design incorporates
both diagnostic and therapeutic endpoints for the RIGS technology,” concluded
Mr. Bupp.
RIGScan
CR, when used with a commercially available hand-held gamma radiation detection
probe, provides surgeons with real-time information used to locate tumor
components not detectable by conventional methods, and assist in the more
thorough removal of the potentially cancerous tissue. The RIGScan CR targeting
agents are monoclonal antibodies labeled with a radioactive isotope that emits
low energy gamma rays. Before surgery, a cancer patient is injected with the
monoclonal antibody targeting agent, which circulates throughout the patient’s
body and binds specifically to cancer cell components (cancer antigens).
Concentrations of the targeting agent are then located during surgery by the
gamma detection device, which emits an audible tone to direct the surgeon to
tumor-involved tissue. Information on the clinical history and current
development status of RIGScan CR can be obtained from Neoprobe’s previous press
releases and filings with the U.S. Securities and Exchange
Commission.
NEOPROBE
CORPORATION
ADD
- - 2
About
Neoprobe
Neoprobe
is a biomedical company focused on enhancing patient care and improving patient
outcome by meeting the critical intraoperative diagnostic information needs of
physicians and therapeutic treatment needs of patients. Neoprobe currently
markets the neoprobe® GDS line
of gamma detection systems that are widely used by cancer surgeons. In addition,
Neoprobe holds significant interests in the development of related biomedical
systems and radiopharmaceutical agents including Lymphoseek® and
RIGScan® CR.
Neoprobe’s subsidiary, Cira Biosciences, Inc., is also advancing a
patient-specific cellular therapy technology platform called
ACT. Neoprobe’s strategy is to deliver superior growth and
shareholder return by maximizing its strong position in gamma detection
technologies and diversifying into new, synergistic biomedical markets through
continued investment and selective acquisitions. www.neoprobe.com
Statements
in this news release, which relate to other than strictly historical facts, such
as statements about the Company’s plans and strategies, expectations for future
financial performance, new and existing products and technologies, anticipated
clinical and regulatory pathways, and markets for the Company’s products are
forward-looking statements The words “believe,” “expect,”
“anticipate,” “estimate,” “project,” and similar expressions identify
forward-looking statements that speak only as of the date
hereof. Investors are cautioned that such statements involve risks
and uncertainties that could cause actual results to differ materially from
historical or anticipated results due to many factors including, but not limited
to, the Company’s continuing operating losses, uncertainty of market acceptance
of its products, reliance on third party manufacturers, accumulated deficit,
future capital needs, uncertainty of capital funding, dependence on limited
product line and distribution channels, competition, limited marketing and
manufacturing experience, risks of development of new products, regulatory risks
and other risks detailed in the Company’s most recent Annual Report on Form
10-KSB and other Securities and Exchange Commission filings. The
Company undertakes no obligation to publicly update or revise any
forward-looking statements.