A Medical Device Daily
Neoprobe (Dublin, Ohio), a developer of oncology and cardiovascular surgical and diagnostic products, said it has signed a term sheet with Cardinal Health (Dublin, Ohio) for the distribution of Lymphoseek on an exclusive basis in the U.S. through Cardinal's more than 150 nuclear pharmacies and wholesale distribution operations to in-hospital nuclear pharmacies.
Lymphoseek (Technetium Tc99m DTPA-mannosyl-dextran) is a radioactive lymphatic mapping agent developed by Neoprobe for use with handheld gamma detection devices, such as Neoprobe's neo2000 system, in a surgical procedure known as Sentinel Lymph Node Biopsy. Neoprobe reported positive preliminary data from a Phase II multicenter clinical trial for Lymphoseek and is preparing to submit a proposed Phase III protocol to FDA.
Details of the term sheet will remain confidential until a definitive marketing and distribution arrangement has been negotiated and signed, Neoprobe said.
David Bupp, Neoprobe's president/CEO, said that the agreement "coupled with our recent announcement of preliminary results for the Phase II clinical evaluation of Lymphoseek, will be an important milestone event for the company."
Neoprobe markets the neo2000 line of gamma detection systems and the Quantix line of blood flow measurement products developed by its subsidiary, Cardiosonix. In addition, Neoprobe holds significant interests in the development of related biomedical systems and radiopharmaceutical agents including Lymphoseek and RIGScan CR.
In other agreement activity, ULURU (Addison, Texas) reported a co-development agreement with Immuneregen BioSciences to evaluate the wound healing potential of a combination of its hydrogel nanoparticle wound dressing and Immuneregen's Homspera therapeutic.
Homspera is derived from Substance P, a naturally occurring peptide immunomodulator and homeostatic compound which stimulates the human immune system. In vivo animal tests, together with data generated by numerous third parties, indicate the potential for this compound to accelerate wound healing, through the up-regulation of growth factors involved in the wound healing process.
ULURU will conduct in vitro and in vivo studies and with completion of preclinical studies will negotiate a license for the wound healing applications of Homspera.
In extensive pre-clinical testing in a variety of wound healing models including full thickness wounds, partial thickness wounds, chemical induced burns and skin graft donor sites wounds, the nanoparticle aggregate wound dressing, without incorporation of any drug, out-performed a market-leading wound care product, the companies said. Additionally, it showed the ability to control the release of active compounds to the wound site for periods up to 30 days.
ImmuneRegen is a development stage biotech focused on the development of Homspera and its derivatives, Radilex and Viprovex, to be used as countermeasures for bioterrorism threats.
ULURU develops wound management, plastic surgery and oral care products providing controlled delivery using its transmucosal delivery system and Hydrogel Nanoparticle Aggregate technology.