Archive for the ‘Neoprobe Corp. NEOP’ Category

Neoprobe Corp. (NEOP.OB) Gets Green Light from European Medicines Agency for Continued Development of RIGScan® CR

Friday, October 31st, 2008

Neoprobe Corporation, a Dublin, Ohio based developer of surgical and diagnostic devices and pharmaceuticals, said today that the European Medicines Agency (EMEA) has approved Neoprobe’s RIGScan® CR cancer detection system for additional testing and development, leading to the potential approval for Neoprobe to market the product throughout the European Union (EU) and affiliated countries.

The EMEA controls the introduction, development, and marketing of medical devices and products in the EU. Neoprobe’s concept for the RIGScan® CR system is a combination of radiation-emitting antibodies with a detection device to assist surgeons in the discovery of tumor deposits that may not be observable by conventional methods.

The company believes it has gotten tangible guidance from the EMEA on how to best continue the design of RIGScan® CR. Furthermore, the EMEA allowed for early termination of additional testing depending on the results. “We are excited by the response from the EMEA,” said David Bupp, Neoprobe’s President and CEO. He noted that the EMEA’s “response provides a clear, achievable development pathway for RIGScan® CR.”

Importantly, he said, “[t]he response acknowledges that the technology meets a currently unmet medical need and has the potential for improving the long term prognosis for both primary and recurrent colorectal patients. The EMEA has suggested a mechanism for an early termination of the study if, as anticipated, early improved outcomes are observed in the RIGScan treatment arm versus the control arm patients.”

Neoprobe, in business since 1983, also announced a conference call for November 6, 2008 at which time Mr. Bupp, and Vice President and CFO, Brent Larson, will provide an update on the company’s Lymphoseek product as well as RIGScan® CR. Additionally, the conference call will cover the company’s results for the third quarter of 2008.

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Neoprobe Corp. (NEOP.OB) Rated Strong Speculative Buy by Dutton; Supported by Radiopharmaceutical

Friday, September 5th, 2008

Dutton Associates, one of the largest independent investment research firms in the United States, today announced it is reiterating its “Strong Speculative Buy” rating with a higher price target of $1.50 for Neoprobe Corp. (OTCBB: NEOP), a biomedical company forecast to generate profit in the second half of 2010 with earnings per share of 12 cents for the full year.

Driving the projection is the company’s commercialization of Lymphoseek, a proprietary radiopharmaceutical currently in development for the identification of sentinel lymph nodes during lymph node biopsies to stage various tumor types, including breast, melanoma, and head and neck carcinomas.

Moving forward with its research, the company has initiated patient recruiting for the first of two phase III clinical trials for Lymphoseek, and expects to commence the second phase III trial in the third quarter. According to the 15-page report by Dutton & Associates, the delay in this second phase III trial from mid-year stems from the company’s efforts to harmonize the design of this trial to support marketing approval in both the United States and Europe.

“Lymphoseek has important clinical advantages over existing radiopharmaceuticals that are currently being used off-label for SLNBs. As the first radiopharmaceutical that may be specifically labeled for the indication, it may enjoy rapid uptake due to its unique labeling and potential for hospitals to access additional reimbursement codes from private and public insurers. The recent distribution letter of intent executed with DRAXIMAGE for Lymphoseek in the EU, Scandinavia, India, Turkey, and Canada could double addressable markets. Coupled with its distribution agreement with Cardinal Health, we believe Lymphoseek will penetrate roughly 10% of its current network of geographic markets for Lymphoseek during the second half of 2010,” senior analyst Dennis C. Fisher, CFA stated.

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Dutton Associates Featured Company: Neoprobe Corp. (NEOP)

Monday, July 21st, 2008

Neoprobe Corporation (NEOP) is an innovator in gamma-guided surgery, dedicated to developing and commercializing new biomedical products to improve the diagnosis, treatment, and quality of life of cancer patients. The company’s subsidiary, Cira Biosciences, Inc., explores the development and commercialization of an activated cellular therapy technology that has shown promising early stage, patient-specific treatment potential in oncology, and viral (HIV/AIDS and hepatitis) and autoimmune diseases. The company’s products are available throughout the world from major distributors, and are supported by a worldwide servicing capability.

Neoprobe Corporation markets their neo2000® Gamma Detection Systems, which include detector probes and accessories, worldwide for surgical procedures called intra-operative lymphatic mapping (ILM) of the sentinel node – a minimally invasive technique for evaluating the potential spread of cancer to lymph node tissues and organs. Currently, multiple large-scale national and international studies are underway to further evaluate the survival advantage of ILM staging in patients with melanoma and breast cancer. Surgeons are using lymphatic mapping to help trace lymphatic patterns in a cancer patient to evaluate potential tumor drainage and cancer spread in lymphatic tissue.

Through their wholly owned subsidiary, Cardiosonix Ltd., Neoprobe has developed the Quantix line of blood flow measurement products to be used for a variety of clinical needs, including: real-time monitoring, intra-operative quantification, non-invasive diagnostics, and the evaluation of blood flow. The blood flow measurement products employ patented Doppler blood flow measurement technology and algorithms, which allows for real-time, angle-independent blood flow volume and velocity readings. Utilizing the Doppler blood flow, the angle of incision can be obtained without the need to use complicated imaging systems, allowing for a more precise measurement of the volume of total blood flow.

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Neoprobe Corporation (NEOP.OB) Receives $3 Million in Clinical Funding

Wednesday, April 16th, 2008

Neoprobe Corporation, a diversified developer of innovative oncology and cardiovascular surgical and diagnostic products, has completed the second closing of $3 million in financing. This funding will help Neoprobe start its Phase 3 clinical studies of Lymphoseek in patients with breast cancer or melanoma and head and neck squamous cell carcinoma.

Montaur issued the funds to Neoprobe in the form of a secured note. The note, which is fully convertible into Neoprobe common shares at $0.36 per share – the closing price of Neoprobe’s common stock on April 10, 2008 when the investment was priced – is repayable in December 2011. In addition, Neoprobe issued Montaur a warrant to purchase up to 8,333,333 shares of Neoprobe common stock at $0.46 per share. Also, as it relates to receiving a final $3 million in funding, Montaur has set a prerequisite for Neoprobe to meet 135 positive lymph nodes in the Phase 3 trial of patients with breast cancer or melanoma.

David Bupp, Neoprobe’s President, said, “The completion of the Montaur financing provides Neoprobe with the financing to initiate the Phase 3 clinical study of Lymphoseek in a timely manner. We expect to begin patient enrollment in the Phase 3 clinical study in patients with breast cancer or melanoma shortly after the FDA-cleared clinical protocol and associated materials receive final clearance from clinical review committees of the investigational sites. The first of the Phase 3 sites have received institutional approvals and we are preparing to commence patient enrollment.”

Michael Goldberg, M.D., Principal, Montaur Capital Partners, LLC and Portfolio Manager of the Platinum Montaur Life Sciences Fund, said, “Neoprobe continues to represent an excellent investment opportunity. We are pleased with their progress since our initial investment and look forward to the successful completion of their pivotal clinical trials.”

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Neoprobe Corporation (NEOP.OB) Stock Increases on Agreement with Cardinal Health

Friday, July 13th, 2007

Cancer and heart disease claim more lives every year than the rest of the top 10 leading causes of death in the U.S. combined. Billions of dollars are spent each year trying to discover preventative measures as well as cures.Neoprobe Corporation (OTCBB: NEOP) is a diversified developer innovating oncology, cardiovascular surgical and diagnostic products. The company’s main focus is the improvement of cancer surgery outcomes. Helping enhance patient needs by meeting the critical decision making needs of health care professionals has been Neoprobes mission since its establishment in 1984.

Neoprobe has several different devices that help assist in the care of patients and discovering the effects post surgery. The company provides several gamma detection devices and blood flow measurement products.

Gamma detection devices are used in cancer surgery to help evaluate the potential spread of cancer to lymph node tissues and organs. This morning the company announced it has signed a term sheet with Cardinal Health for the marketing and distribution of Lymphoseek on an exclusive basis in the United States through Cardinal Health’s network of over 150 nuclear pharmacies.

Lymphoseek is a proprietary, radioactive lymphatic mapping targeting agent being developed by Neoprobe for use with handheld gamma detection devices in a procedure known as Sentinel Lymph Node Biopsy.

Neoprobe’s CEO, David Bupp, said in a press release “We are very pleased to have the opportunity to establish business terms for the marketing and distribution of Lymphoseek in the United States. The completion of this agreement, coupled with our recent announcement of preliminary results for the Phase 2 clinical evaluation of Lymphoseek, will be an important milestone event for the company.”

Neoprobe’s stock price has increased almost 4 cents today, or 13 percent, to about 32 cents. The stock has increased 8 cents already this week as the company has approached a new high over the last month. This new partnership might spark more growth and help Neoprobe increase not only in size but value.

Dutton Associates Highlights: Neoprobe Corp. (NEOP.OB) with a “Strong Speculative Buy” Rating; as Company Reports Phase 2 Clinical Trial Results

Wednesday, June 27th, 2007

Neoprobe Corporation (NEOP.OB), a diversified developer of innovative oncology and cardiovascular surgical and diagnostic products, reports positive preliminary results from a multicenter Phase 2 clinical study of its lead clinical candidate, Lymphoseek®. (Technetium Tc99m DTPA-mannosyl-dextran).

Lymphoseek is a proprietary radioactive targeting agent being developed for use with handheld gamma detection devices, such as Neoprobe’s neo2000® system, in a surgical procedure known as Sentinel Lymph Node Biopsy (SLNB).

The primary endpoint of this multicenter, single-arm, open-label, within-patient, single-dose, multi-stage trial measured the rate at which Lymphoseek localized to lymphoid tissue with a goal of achieving 90% localization.

In results reported today, localization of Lymphoseek to lymphoid tissue was observed in over 94% of the SLNB procedures performed as a part of the Phase 2 trial in patients with either breast cancer or melanoma.
 
Neoprobe is a biomedical company focused on enhancing patient care and improving patient outcome by meeting the critical intraoperative diagnostic information needs of physicians and therapeutic treatment needs of patients.

Neoprobe currently markets the neo2000® line of gamma detection systems that are widely used by cancer surgeons and is commercializing the Quantix® line of blood flow measurement products developed by its subsidiary, Cardiosonix Ltd.

In addition, Neoprobe holds significant interests in the development of related biomedical systems and radiopharmaceutical agents including Lymphoseek® and RIGScan® CR.

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