Date: Thu, 18 Dec 1997 18:18:44 GMT Server: Apache/1.0.5 Content-type: text/html Content-length: 7214 Last-modified: Mon, 06 Oct 1997 21:49:09 GMT
Neoprobe made great strides in 1995 toward completing the development of our initial product, RIGScan CR49 for surgical detection of metastatic colorectal cancer. We concluded our pivotal multicenter clinical testing for the product in the United States and Europe and put manufacturing scale-up and Distribution networks in place. These accomplishments in 1995 allow us to compile RIGScan CR49 marketing applications in 1996, with an eye toward potential product launch next year.Our achievement of these important clinical and manufacturing milestones along with improving financial market conditions helped us secure $25.3 million in funding. Our accomplishments were also reflected in our stock performance. Neoprobe was recognized as the top biotechnology stock performer in 1995 with more than a 10-fold increase.
The significance of our achievements reaches into the future. A marketing approval for RIGScan CR49 will launch the first of many potential RIGS surgical and therapy products that we intend to establish as a new standard of care for cancer patients.
RIGScan CR49 Product Focus
We announced Phase II clinical results with RIGScan CR49 in March at a special symposium at the Society of Surgical Oncology (SSO) annual meeting. We completed Phase III testing with metastatic colorectal cancer patients in August in the United States and Europe—24 U.S. and European cancer centers and hospitals tested the product’s safety and effectiveness. We began pre-product-submission discussions with the United States Food and Drug Administration (FDA) and European authorities. In June we met with the FDA regarding RIGScan CR49 manufacturing scale-up. In November we sent a preliminary Phase III data analysis to the FDA and held a very productive pre-PLA (Product License Application) discussion and review at FDA headquarters in January 1996. We entered into distribution service agreements for North American, European, African, and Middle Eastern markets. We completed our first marketing partnership in Asia. Our international network of subsidiaries and corporate partners are establishing GMP scale-up manufacturing to meet commercial demand. We also began discussions with potential corporate marketing partners with the intention of finalizing our marketing strategy in 1996.These activities are the foundation for successful regulatory review and approval, launch, and sales of our RIGS products.
Clinical Studies
Our progress in clinical research and in communicating RIGS research to the medical community in 1995 was a significant achievement.
At the 1995 SSO meeting, John Daly, M.D., Surgeon-in-Chief, New York Hospital, presented Phase II results with RIGScan CR49 for colorectal cancer patients. The RIGS system found pathology-confirmed hidden tumor in 20% of patients. Most of these patients had treatment decisions changed by the information provided by the RIGS technology.
Other studies providing follow-up of RIGS colorectal cancer patients at one site were presented at medical meetings and published in peer-reviewed journals throughout the year. These presentations and papers suggest that patients who have all RIGS-identified tissue removed during their operation have a better long-term outcome.
Additional studies of RIGS products for colorectal cancer therapy, surgical detection of childhood neuroblastoma, and intraoperative lymphoscintigraphy were also presented and published in 1995.
Results of the company’s sponsored pilot/Phase I study with RIGS/ACT™ (activated cell therapy) suggested that the therapy has potential to extend the survival of late-stage colorectal cancer patients. This product is based on RIGScan CR49 and may significantly extend the market for the product.
In a pilot study using the company’s proprietary targeting agent for neuroblastoma, RIGS localized tumor in all six children and found hidden tumor in three.
Use of the Neoprobe 1000 instrument for intraoperative lymphoscintigraphy for melanoma patients has been reported by researchers throughout the year. Use of the technique is rapidly increasing, and training programs by physicians at the H. Lee Moffitt Cancer Center in Florida are now ongoing.
RIGS researcher, Mark W. Arnold, M.D., of The Ohio State University,was invited to edit an entire issue of Seminars in Colon and Rectal Surgery. The journal issue consisted of nine papers on RIGS research and appeared in December.
All of these efforts toward educating the medical community about the potential benefits of the RIGS system will help prepare the market for product introduction.
Instrument and Intellectual Property Developments
Neoprobe received six United States patents in 1995. Two patents cover a laparoscopic version of the probe and a method for minimally invasive evaluation of cancers in the abdominal and pelvic regions. A third patent allows claims for a finger-mounted probe that may allow surgeons to survey tissue deep within the abdomen, even as far as areas around the spinal cord. Two additional patents cover improvements in the Neoprobe 1000 instrument that increase accuracy and efficiency. Finally, Neoprobe received a patent covering the RIGS method for "biostaging," referring to the role of RIGS information in determining the stage, or extent, of a patient’s disease.
Our Future
This year’s report to shareholders tells the story of Neoprobe’s progress to date toward providing innovative biomedical products to improve the diagnosis and treatment of cancer. We are positioning the company now to emerge from our current research and development stage into future commercial success. The beneficiaries of our RIGS technology will be cancer patients, their caregivers and families. At the same time, we are increasing shareholder value for all of you who support our efforts on their behalf.Sincerely,
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John L. Ridihalgh, Chairman of the Board and Chief Executive Officer
David C. Bupp, President and Chief Operating Officer