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IMMEDIATE
RELEASE
|
February
14, 2011
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NEOPROBE’S
PHASE 3 LYMPHOSEEK STUDY REACHES ACCRUAL GOAL
--
Clinical Study Evaluated Subjects with Breast Cancer or Melanoma --
DUBLIN,
OHIO – February 14, 2011 -- Neoprobe Corporation (NYSE
Amex: NEOP), a diversified developer of innovative oncology surgical and
diagnostic products, today announced that a multi-center Phase 3 study of
Lymphoseek® has
enrolled clinical subjects to achieve the minimum analysis goal of 196 lymph
nodes, the study’s primary accrual objective. The multi-center open label study
was conducted in subjects with either breast cancer or melanoma in accordance
with the clinical protocol registered on www.clinicaltrials.gov (NCT01106040).
“Neoprobe
is pleased to announce the completion of this milestone and its significance in
helping us advance toward fulfilling the regulatory requirements for a potential
Lymphoseek approval by FDA,” said David Bupp, Neoprobe’s President and CEO. “We
are highly confident that the end points of the clinical study will be met and
anticipate that full data will be available early in the second quarter
following review by our clinical team. We will hold a conference call at that
time to discuss the clinical study results and the presentation of the results
are planned at scientific conferences later in the second quarter.”
An
earlier Phase 3 multi-center study (NEO3-05) of Lymphoseek was conducted in
subjects with breast cancer or melanoma. In the NEO3-05 study an overall
localization rate of over 97% in lymph nodes was achieved in those patients
where both a vital blue dye and Lymphoseek were used. A similar concordance rate
was established by Neoprobe and FDA as the primary efficacy objective for the
NEO3-09 Phase 3 clinical study. No incidents related to drug safety have been
reported in the Lymphoseek studies.
Contacts:
Neoprobe
Corporation -- Brent Larson, Sr. VP & CFO – (614) 822-2330
Investor
Relations – Michael Rice, LifeSci Advisors -- (201) 408-4923
Public
Relations/Media Relations – Mark Marmur, Makovsky & Co. -- (212)
508-9670
About
Lymphoseek
Lymphoseek
is a proprietary radioactive tracing agent being developed for use in connection
with gamma detection devices in a surgical procedure known as Intraoperative
Lymphatic Mapping (ILM). One
Phase 3 multi-center clinical trial for Lymphoseek in patients with breast
cancer or melanoma has been successfully completed and a second Phase 3 clinical
study in the same patient population is nearing completion to support the filing
of a New Drug Application. A third Phase 3 clinical study to evaluate the
efficacy of Lymphoseek as a sentinel lymph node tracing agent in patients with
head and neck squamous cell carcinoma is underway. Additional
information related to clinical trials being performed with Lymphoseek is
available at www.clinicaltrials.gov.
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more -
About
Neoprobe
Neoprobe
is a biomedical company focused on enhancing oncology patient care and improving
patient benefit. 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
RIGScanTM
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-K and other Securities and
Exchange Commission filings. The Company undertakes no
obligation to publicly update or revise any forward-looking
statements.