Gemin X announced today that it has initiated a Phase 1 clinical trial with GMX1777 in patients with refractory solid tumors and lymphomas. The compound, licensed worldwide from LEO Pharma, is a water-soluble, intravenously administered prodrug of the LEO Pharma compound CHS828.

Gemin X performed extensive preclinical studies on GMX1777 to optimize the exposure and therapeutic potential of the compound and completed IND-enabling studies to launch the first human clinical trial of the prodrug. The prodrug is expected to provide a more favorable therapeutic index than the orally administered CHS828. The open-label, dose-escalation trial will enroll approximately 18-24 patients with refractory solid tumors and lymphomas at a single center. Patients will receive infusions of GMX1777 as a single agent in 3-week cycles. The objectives of this study are to determine the toxicity and pharmacokinetic profile of the compound, document any anti-tumor activity, and establish a recommended dose and schedule for Phase 2 trials.

“The addition of GMX1777 to our portfolio illustrates Gemin X’s commitment to broadening our pipeline with promising oncology drug candidates,” said Gordon Shore, Ph.D., Chief Scientific Officer of Gemin X. “In preclinical models, the candidate induced potent tumor regression in multiple tumor types via a novel mechanism of action, giving it broad potential as a treatment for several different cancers. We are pleased to work with LEO Pharma, a well-respected global pharmaceutical company, to drive the continued successful development of GMX1777.”

Under the terms of the agreement, Gemin X has an exclusive license to develop and market GMX1777 worldwide. In return, LEO Pharma has received an upfront payment, and is eligible to receive payments upon achievement of certain development and regulatory milestones, in addition to royalties on net sales. Specific financial terms of the deal were not disclosed.

“We believe that Gemin X is the ideal company to further develop this compound because of its focus on targeted cancer therapies, and we are optimistic about the future of GMX1777,” said Ernst Lundig, CEO of LEO Pharma. “This license agreement is important to LEO Pharma, because it highlights our core competencies in innovative research and development.”

GMX1777 is a small molecule compound with potent anti-tumor activity in vitro and in vivo. In preclinical models, it has demonstrated tumor regressions in prostate, breast, lung, and colon carcinomas, as well as in multiple myeloma and fibrosarcoma tumors. Studies at Gemin X reveal that the compound operates through a novel mechanism and is thought to kill cancer cells independently of the p53 tumor suppression protein and has been observed to inhibit the activation of the transcriptional factor NFkB, which plays a role in the survival of cancer cells.

LEO Pharma is specialized in dermatology (primarily psoriasis and skin infections) and critical care (hemostasis and nephrology). In 2006 LEO Pharma had revenues of MEUR 695 with profit before tax of MEUR 408. The equity position in 2006 was MEUR 2,072. LEO Pharma is a Pan-European company with subsidiaries in most European countries as well as in Canada, Middle East, and Far East. LEO Pharma is headquartered in Denmark and its products are sold in 90 countries and the company employs 3,000 people. LEO Pharma is 100% owned by the LEO Foundation. The sole purpose of the Foundation is to run LEO Pharma as an independent pharmaceutical company. www.leo-pharma.com

Gemin X Biotechnologies Inc. specializes in the discovery and development of novel small molecule cancer therapeutics based on the regulation of apoptosis, the body’s natural ability to destroy injured or damaged cells. Gemin X’s lead product, GX15-070, is a small molecule, pan-inhibitor of Bcl-2 proteins and is currently in Phase 2 clinical trials. Gemin X is also developing a small molecule that induces apoptosis in p53-defective cancers. Gemin X is privately held and is located in Montréal, Quebec and Malvern, Pennsylvania.