Innovive Pharmaceuticals, Inc., a Manhattan based public biopharmaceutical company, has licensed the patent rights from KTB Tumourforschungs GmbH, a free-standing research institute based in Freiburg, Germany, for the worldwide development and commercialization of DOXO-EMCH, a novel doxorubicin prodrug. Innovive has renamed the compound INNO-206 and plans to initiate a phase II study in a solid tumour indication shortly.

INNO-206 is a prodrug of the commonly used chemotherapeutic doxorubicin. Once administered, INNO-206 binds circulating albumin via an acid sensitive linker. Circulating albumin is known to preferentially accumulate in tumours. Once in the acidic environment of the tumour, the albumin bound INNO-206 is cleaved to release free doxorubicin.

A phase I study of INNO-206 that demonstrated safety and objective clinical responses in a variety of tumour types was completed earlier this year and presented at the March 2006 Krebskongress meeting in Berlin. In this study, doses were administered at up to 4 times the standard dosing of doxorubicin without an increase in observed side effects over historically seen levels. Objective clinical responses were seen in patients with sarcoma, breast, and lung cancers.

"We believe INNO-206 is an excellent addition to Innovive's expanding oncology pipeline," said Steven Kelly, Innovive's President and CEO. "This drug combines a proven mechanism of action in oncology, a means to dose escalate without the near and long term adverse events previously seen with anthracyclines, and potentially adds tumour targeting properties.

"We are delighted to be working with Innovive on the development of INNO-206. Innovive's proven track record of in-licensing and aggressively developing products should help ensure the rapid clinical development of this compound," said Arno Fritzen, Commercial Director of KTB.

Anthracyclines are some of the most commonly used agents in the treatment of cancer. Efficacy with doxorubicin has been demonstrated in solid tumours including breast and lung cancers, sarcomas, and lymphomas.

INNO-206 is the (6-Maleimidocaproyl) hydrazone of doxorubicin. INNO-206 is a prodrug of doxorubicin that binds endogenous albumin after administration. The bound doxorubicin is released in the acidic environment of the tumour cell through cleavage of an acid sensitive linker. In pre-clinical models, INNO-206 was superior to doxorubicin