In oncology, radioactive tracers and gamma detection system probe are used in identifying the first lymph node to which cancer cells will spread from the primary tumor site as well as in identifying the stage of cancer.
In what is claimed to be the first in health care field - developing both gamma detection systems and radio tracers, is biomedical company Neoprobe Corp. (NEOP). The company markets gamma detection systems, detector probes and accessories, which are used for surgical procedures called Intraoperative Lymphatic Mapping or sentinel lymph node biopsy, a minimally invasive technique to assess the potential spread of cancer.
The company's investigational initiatives include, Lymphoseek, RIGScan CR and Activated Cellular Therapy.
For readers who are new to Neoprobe, here's what to expect in the coming months...
The company's most-advanced product is Lymphoseek, a proprietary radioactive tracing agent, being developed for use in connection with gamma detection devices in Intraoperative Lymphatic Mapping. Neoprobe has successfully completed 2 phase III studies of Lymphoseek in patients with breast cancer or melanoma.
In clinical trials, Lymphoseek compared favorably with Vital Blue Dye, the standard of care, in detecting lymph nodes. Neoprobe remains on track to submit the new drug application for Lymphoseek during this quarter. (3Q). Analysts have pegged the market potential of Lymphoseek at $370 million per year.
Under an agreement signed in November 2007, Cardinal Health has exclusive U.S. rights to distribute Lymphoseek for an initial term of five years following its FDA clearance.
Seeking to maximize the value of Lymphoseek and the potential of the company's pipeline in the European Union, Neoprobe has established a European business unit. The company is also engaged in the process of identifying and establishing relationships with key partners who can provide marketing, sales and distribution capabilities using existing infrastructure for Lymphoseek and other products.
Neoprobe shares took a hit on July 22, following the FDA approval of Sulfur Colloid Injection, a radioactive tracer to locate lymph nodes in breast cancer patients. Sulfur Colloid Injection, or SCI for short, is developed by a private company Pharmalucence Inc. The approval was based on a systematic literature review of published scientific articles that describe the efficacy and safety of SCI versus a blue dye used in lymph node localization.
As follow up, Pharmalucence is also planning to submit another filing seeking approval of Sulfur Colloid Injection in lymph node localization in melanoma patients.
Doubting that Neoprobe will be asked to conduct another trial to prove the non-inferiority of Lymphoseek to the recently approved SCI, investors drove down the stock by nearly 15% to $2.86 on July 22.
Commenting on the approval of Pharmalucence's Sulfur Colloid Injection, Mark Pykett, Neoprobe's President and CEO clarified that the approval of SCI has not changed his company's previously stated plan to submit the NDA for Lymphoseek during the third quarter.
RIGScan CR is another investigational radiopharmaceutical of Neoprobe. The RIGS system combines a patented hand-held gamma radiation detection probe and proprietary radiolabeled cancer-specific tracing agent to locate tumor deposits generally not detectable by conventional methods.
Neoprobe undertook the development of RIGScan in the mid 1990s. The company sought the approval of FDA and EMA for RIGScan CR for the detection of metastatic colorectal cancer in 1996 based on two phase III studies, NEO2-13 and NEO2-14.
Though both the FDA and EMA acknowledged that the phase III studies of RIGScan met the diagnostic endpoint of providing incremental information to the surgeon regarding the location of hidden tumor, the regulatory agencies were not satisfied with the clinical benefit provided by RIGScan to metastatic colorectal cancer patients.
Neoprobe withdrew its Biologics License Application seeking approval of RIGScan in the EU in November 1997. The following month - in December 1997, the FDA denied approval for RIGScan , citing certain clinical and manufacturing deficiencies.
Over the course of time, the survival analyses of patients treated with RIGScan CR prepared by third parties have revealed favorable results relating to the long-term survival prognosis of patients who were treated with RIGScan. The favorable outcome of RIGScan was not known at the time when its Biologics License Application was reviewed. In late 2008, Neoprobe obtained approval from EMA for a phase III clinical protocol for RIGScan.
After nearly 14 years, Neoprobe reactivated the development of RIGScan. In March of this year, the company completed a successful pre-IND meeting with the FDA on the development of RIGScan. The positive guidance from the FDA allows Neoprobe to restart clinical studies of RIGScan next year.
According to Neoprobe, the total potential global market for RIGScan could be in excess of $3 billion annually, depending on the level of reimbursement allowed.
ACT (activated cellular therapy) technology for patient-specific disease treatment is also Neoprobe's investigational initiative. Though the company is exploring the development of its ACT technology, over the last few years the company has been focused only on Lymphoseek and RIGScan.
A quick look at the company's balance sheet...
The company currently generates revenue primarily from sales of its gamma detection products. In the first quarter ended March 31, 2011, total revenue which comprised of net sales and license & grant revenue were $2.84 million compared to $2.68 million in the year-ago quarter. Net loss for the first quarter of 2011 widened to $4.4 million or $0.05 per share from $2.5 million or $0.03 per share in the first quarter of 2010.
Neoprobe was incorporated in 1983. From inception through the first quarter of 2011, the company had an accumulated deficit of $255 million. The company is scheduled to release its earnings for the second quarter of 2011 after the market close on Wednesday, July 27, 2011.
NEOP has a 52-week price range of $1.50 to $5.48. The stock which shed nearly 15% on Friday to close at $2.86, has recovered some of its losses and is trading around $3 on a volume of 2.4 million shares.
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