Neoprobe Receives Positive Scientific Advice from European Medicines Agency (EMA) for RIGScan CR
September 07 2011 - 4:30PM
Business Wire
Neoprobe Corporation (NYSE Amex: NEOP), a diversified developer
of innovative diagnostic products, today announced that it received
positive scientific advice late last week from the European
Medicines Agency (EMA) on the development of RIGScanTM CR, the
Company’s proprietary radiopharmaceutical for the detection of
colorectal cancer.
In the EMA meeting, Neoprobe sought scientific guidance on the
chemistry, manufacturing and controls (CMC) related to RIGScan and
on non-clinical requirements needed to resume clinical development.
EMA provided positive feedback on these development activities and
on Neoprobe’s plan for manufacturing and non-clinical testing.
Importantly, EMA confirmed the opportunity for Neoprobe to consider
evaluating a humanized RIGScan antibody for clinical development
and commercialization.
The meeting with the European regulatory body follows a
successful pre-investigational new drug (IND) meeting with the Food
and Drug Administration (FDA) earlier this year. Potential use of a
humanized antibody form instead of a mouse-based antibody is an
important, positive development enabling utility of an improved
technology, state-of-the art manufacturing processes and a more
clinically acceptable drug. The potential shift to a humanized
structure would better position the product for regulatory
approval, partnering, commercialization and enhanced intellectual
property protection opportunities.
“Following review of our development package, EMA provided
important guidance on our RIGScan development plan which allows us
to maintain our current activities in re-starting manufacturing of
the RIGScan antibody,” said Rodger Brown, Vice President,
Regulatory Affairs and Quality Assurance of Neoprobe. “Positive
guidance from both agencies enables us to begin harmonized efforts
to reintroduce RIGScan back into the clinic. We are evaluating the
overall implications on our clinical plans of the specific feedback
received from these two agencies, but the guidance received to date
from regulatory authorities is consistent with our objective of
bringing the technology back into clinical development.”
The Company does not believe that the transition to a humanized
antibody would delay the ongoing CMC process development activities
underway since the FDA pre-IND meeting. Additionally, based on the
discussion of clinical objectives for RIGScan with EMA, the Company
does not envision that a change to the humanized antibody form will
increase the anticipated overall number of patients required for
registration. Detailed plans for clinical development must be
presented to and discussed with both FDA and EMA to align, to the
extent possible, the clinical studies required for approval.
“Positive feedback from EMA and FDA is a critical step toward
reactivating the RIGS® technology development effort after being
out of the clinical setting for more than 14 years,” said Dr. Mark
Pykett, Neoprobe President and Chief Executive Officer.
“Re-initiating any program on the sidelines for an extended period
requires clear, deliberate steps. The opportunity to move away from
an antiquated mouse-based antibody to a state-of-the-art humanized
form can potentially provide important return on our investment. We
look forward to clarifying next steps in the coming months toward
bringing our RIGS program back online and moving ahead with
developing a novel agent aimed at improving diagnosis and treatment
for colorectal cancer patients.”
About RIGScanTM CR
Neoprobe’s RIGScanTM CR is being developed as a diagnostic
technology for the intra-operative detection of clinically occult
or metastatic disease in patients with colon or rectal cancer.
RIGScan is a targeting antibody consisting of a radiolabeled
monoclonal antibody tagged with any of several potential
radioisotopes to help detect cancer in patients having colorectal
cancer. Previous clinical studies in patients with colorectal
cancer demonstrated that RIGScan detected, at a significant rate,
the presence of occult tumor that had been missed during surgery.
In 2004, survival analyses of patients with colorectal cancer
enrolled in the RIGScan clinical studies indicated that RIGScan
status was potentially correlated with patient survival trends and
that RIGScan may be predictive of, or possibly contribute to, a
positive outcome when measuring survival of patients that
participated in earlier studies. Based on these findings and the
continued unmet medical need in identifying tumors in patients with
colorectal cancer and potentially other cancers, Neoprobe has
reinitiated development of RIGScan CR. Additional information about
RIGScan CR can be found at www.neoprobe.com/RIGScan-CR.html.
About Neoprobe
Neoprobe Corporation (NYSE Amex: NEOP) is a biomedical company
focused on development of precision diagnostics that enhance
patient care and improve patient benefit. Neoprobe is actively
developing and commercializing targeted agents aimed at the
identification of occult (undetected) disease. The Company’s two
lead radiopharmaceutical agent platforms – Lymphoseek® and RIGScan™
– are intended to help surgeons better identify and treat certain
types of cancer. In achieving its goals, our business model
leverages collaborations and partnerships with world-class
institutions, manufacturing concerns and distribution entities.
Neoprobe’s strategy is to deliver superior growth and stockholder
return by bringing to market novel radiopharmaceutical agents and
advancing the Company’s pipeline programs through continued
investment and selective acquisition or in-licensing of
complementary technologies. For more information, please visit
www.neoprobe.com.
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including, but not limited to, the Company’s continuing operating
losses, uncertainty of market acceptance of its products, reliance
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product line and distribution channels, competition, limited
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products, regulatory risks and other risks detailed in the
Company’s most recent Annual Report on Form 10-K and other
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