A Medical Device Daily
After getting the green light from FDA to begin patient enrollment in a Phase III multi-center clinical study of Lymphoseek, Neoprobe (Dublin, Ohio) has completed the closing of $3 million in financing from Platinum Montaur Life Sciences.
Neoprobe said it would use the funding to begin its Phase III clinical studies of Lymphoseek in patients with breast cancer or melanoma and head and neck squamous cell carcionoma. A radioactive tracing agent, Lymphoseek is being developed for use in connection with gamma detection devices in intraoperative lymphatic mapping procedures, the company noted.
Neoprobe reported that FDA has agreed with its plan to begin patient enrollment in a Phase III multi-center clinical study to evaluate the safety and efficacy of Lymphoseek. The company said it plans to enroll about 200 patients at up to 25 cancer treatment centers in the U.S. and Europe.
The funding was committed to the company as part of a $13 million agreement with Montaur, which Neoprobe reported signing in December (Medical Device Daily, Dec. 28, 2007).
The $3 million funding is in the form of a secured note due in December 2011, fully convertible into Neoprobe common shares at 36 cents a share. In addition, Neoprobe issued Montaur a warrant to buy up to 8,333,333 shares of its common stock at 46 cents a share.
"To date, the clinical and preclinical results that have been completed demonstrate the benefits of Lymphoseek," said David Bupp, Neoprobe's president.
The company expects to begin patient enrollment in the first Phase III clinical study soon after the FDA-approved clinical protocol and associated material receive final clearance from review committees of the investigational sites, Bupp said.
Neoprobe said it also is preparing for a second Phase III trial to involve less than 200 patients with head and neck squamous cell carcinoma. The study is proposed to be conducted in patients undergoing full nodal dissection for the staging of head and neck squamous cell carcinoma and is intended to validate Lymphoseek as a lymph node targeting agent for use in intraoperative lymphatic mapping procedures, the company said. The second Phase III trial is expected to begin around mid-year.
Originally, Montaur had agreed to another $3 million in financing once enrollment of 200 patients in the Phase III studies of Lymphoseek was complete. However, Montaur and Neoprobe have modified that prerequisite milestone. Now, the company will receive the final $3 million upon obtaining 135 lymph nodes in the Phase III trial of patients with breast cancer or melanoma.
The first funding of $7 million was also in the form of a secured note, due December 2011, partially convertible at the option of Montaur into shares of Neoprobe common stock at 26 cents a share.
Neoprobe develops oncology and cardiovascular surgical and diagnostic products.
In other financing activity: Kinetic Concepts (KCI; San Antonio) reported the pricing of its offering of $600 million of 3.25% convertible senior notes due 2015. KCI has also said it would sell up to $90 million of notes upon exercise of an over-allotment option granted to the initial purchasers.
KCI first reported its plans to offer the $600 million in notes earlier this week (MDD, April 16, 2008).
The notes will mature on April 15, 2015, unless previously converted or repurchased in accordance with their terms. The notes are not redeemable by KCI prior to the maturity date.
Upon conversion, holders will receive cash up to the aggregate principal amount of the notes being converted and shares of KCI common stock in respect of the remainder, if any, of KCI's conversion obligation in excess of the aggregate principal amount of the notes being converted.
The initial conversion rate for the notes will be 19.4764 shares of KCI common stock per $1,000 principal amount of notes, which is equivalent to an initial conversion price of roughly $51.34 a share of common stock and represents a 27.5% conversion premium over the last reported sale price of KCI's common stock on April 15, which was $40.27 a share.
The conversion rate and the conversion price will be subject to adjustment in certain events, such as distributions of dividends or stock splits.