Neoprobe researcher presents results with cancer detection system; Neoprobe begins pre-submission discussions with FDA; Announces 1st quarter results.DUBLIN, Ohio--(HealthWire)--May 15, 1995--Neoprobe Corp. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on NMS See NetWare Management System. : NEOP NEOP Neoprobe Corporation (stock symbol) NEOP Near Earth Object Program NEOP New England Order of Protection NEOP Nuclear Explosive Operating Procedure , NEOPW) announced that data from a study with the company's RIGS(R) technology for finding cancer during surgery were presented at the annual American Society of Colon and Rectal Surgeons meeting in Montreal, Canada. Dr. Mark W. Arnold, of the Ohio State University Ohio State University, main campus at Columbus; land-grant and state supported; coeducational; chartered 1870, opened 1873 as Ohio Agricultural and Mechanical College, renamed 1878. There are also campuses at Lima, Mansfield, Marion, and Newark. Hospital (OSU (Open Source UNIX) Refers to the Unix variants that are maintained as open source, which were primarily BSD Unix and Linux until Sun made its Solaris operating system open source in 2005. ), presented results indicating that the RIGS system has great potential to enhance the surgeon's assessment of disease spread in colorectal cancer colorectal cancer Malignant tumour of the large intestine (colon) or rectum. Risk factors include age (after age 50), family history of colorectal cancer, chronic inflammatory bowel diseases, benign polyps, physical inactivity, and a diet high in fat. patients. The study of 86 patients showed that RIGS used during surgery found significantly more lymph nodes Lymph nodes Small, bean-shaped masses of tissue scattered along the lymphatic system that act as filters and immune monitors, removing fluids, bacteria, or cancer cells that travel through the lymph system. for disease evaluation than the surgeon could have found using traditional techniques. RIGS found 341 sites of disease, while conventional surgical techniques found only 158. The patients were enrolled in a Phase I/II study conducted at OSU from 1990 to 1992 under the sponsorship of the National Cancer Institute's Cancer Therapy Evaluation Program (CTEP CTEP Cancer Therapy Evaluation Program CTEP Community Transportation Enhancement Program (Montana) CTEP Chartered Trust and Estate Planner CTEP Community Technology Empowerment Project CTEP Collaborative Teacher Education Program ). Dr. Arnold said, "A better understanding of where disease is spreading is the first step in improving surgical treatment. When you know where to look and have a tool to find tissue at risk that is not identifiable by other means, the potential to cure the patient increases. In this study, RIGS found more than twice the number of sites as the surgeon using all available methods." "A big tumor is obvious," Dr. Arnold continued, "but lymph nodes are small and may look deceptively de·cep·tive·ly adv. In a deceptive or deceiving manner; so as to deceive. Usage Note: When deceptively is used to modify an adjective, the meaning is often unclear. normal. RIGS may be showing us which lymph nodes are involved in the disease process. In the past we biopsied this tissue, and if the pathologist could find no cancer cells cells once believed to be peculiar to cancers, but now know to be epithelial cells differing in no respect from those found elsewhere in the body, and distinguished only by peculiarity of location and grouping. See also: Cancer under the microscope, we left RIGS-positive tissue behind, and those patients had a poor outcome." In the RIGS treatment, patients are injected with a low-level radioactive targeting agent before surgery. The targeting agent adheres to cancer sites but not to healthy tissue. During surgery, the doctor uses a small hand-held radiation detector to pinpoint tissue containing even very small amounts of the cancer-targeting agent. FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. Discussions In addition, the company announced it has begun a series of pre-product-submission meetings with the FDA. Neoprobe had a meeting with the FDA on April 28th regarding commercial manufacturing facilities and validation processes. The meeting confirmed that Neoprobe can submit its subsidiary, MonoCarb AB, as the holder of the Establishment License Application (ELA Noun 1. ELA - an extreme leftist terrorist group formed in Greece in 1971 to oppose the military junta that ruled Greece from 1967 to 1974; a revolutionary group opposed to capitalism and imperialism and the United States Revolutionary People's Struggle ) for RIGScan(R) CR49. The meeting also clarified Neoprobe's validation processes to certify MonoCarb. As a result of the meeting, Neoprobe has confirmed timelines for submitting an Establishment License Application (ELA) to the FDA in early 1996. The company has requested another meeting in June to discuss its Product License Applications (PLAs) for the RIGS colorectal cancer products. In the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. , two applications, one for the product and one for commercial-scale manufacturing, must be submitted simultaneously. In Europe, the product application may precede a manufacturing application. Neoprobe's two multicenter Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA trials, conducted at over 30 U.S. and European sites, have accumulated a large body of data to confirm and extend results of earlier RIGS studies such as Dr. Arnold's. The company's president David Bupp said, "We are on track for product license admissions for marketing approval in Europe later this year and in the United States early next year." Bupp added, "We want to have the technology available to our clinical investigators during the time of regulatory product review, if possible. Therefore, we are exploring submitting treatment INDs or other new studies to the FDA to ensure that surgeons continue to have access to the RIGS technology." 1st quarter results The company announced a first quarter operating loss operating loss The excess of operating expenses over revenue. As with operating income, operating losses exclude revenues and expenses from operations that are not considered a regular part of the business. Also called deficit. Compare operating income. of $2.5 million which was in keeping with expectations. Product revenue for the quarter was $273,000, and other income including interest income for the quarter was $212,000. Operating expenses Operating expenses The amount paid for asset maintenance or the cost of doing business, excluding depreciation. Earnings are distributed after operating expenses are deducted. for the quarter were $2,869,000 including research and development expenses for the quarter of $1,954,000. Research and development expenditures during the first quarter were almost exclusively focused on activities associated with the company's Phase III clinical studies for colorectal cancer. Research and development expenses increased approximately $247,000 (15%) in the first quarter of 1995 than comparable 1994 expenses. General and administrative expenses declined approximately $94,000 (9%) compared to first quarter 1994 expenses. Neoprobe Corp, located in Dublin, is developing and commercializing its patented RIGS technology, consisting of gamma-detecting instruments, specific cancer-targeting agents, and methods for their use. Neoprobe's RIGS products are designed to improve the standard of care, enhance quality of life, and extend survival for cancer patients. -0-
Neoprobe Corporation
Operating Data
(unaudited)
Three Months Ended
March 31, March 31,
1994 1995
Sales $38,361 $273,023 Cost of sales 28,599 157,393 Gross margin 9,762 115,630 Operating expenses: Research and development 1,708,154 1,954,242 General and administrative 1,008,603 914,797 Loss from operations (2,706,995) (2,753,409) Other income, net 141,502 212,111 Net loss ($2,565,493) ($2,541,298) Net loss per share (primary) ($0.31) ($0.21) Net loss per share (fully-diluted) ($0.31) ($0.21) Average shares o/s (primary) 8,243,873 11,856,684 Average share o/s (fully-diluted) 8,243,873 11,856,684 CONTACT: Neoprobe Corporation David C. Bupp or Judy Barnes, 614/793-7500 or Sunrise Financial Group Inc. Derek Caldwell, 212/421-1616 |
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