Gemin X Presents Positive Preclinical Data of GX15-070 in Infant ALL at AACR Meeting.

Targeted Cancer Therapy Demonstrates Potent Single Agent Activity and Synergy with Other Drugs

MONTREAL & MALVERN, Pa. -- Gemin X today announced the presentation of positive preclinical data from a study of its lead compound, GX15-070 (obatoclax), in infant acute lymphoblastic leukemia (ALL). The study was discussed in an oral presentation at the Annual Meeting of the American Association for Cancer Research (AACR). According to the study, GX15-070 demonstrated potent single agent activity against ALL blast cells, and also enhanced chemosensitivity and was synergistic with cytotoxic drugs. GX15-070 is a small molecule specifically designed to inhibit all relevant members of the Bcl-2 protein family, a validated cancer target, restoring the natural cell death process of apoptosis.

In this study, researchers obtained leukemia blast cells from five infants and one child with primary ALL. The blasts were exposed to GX15-070 as a single agent in vitro for three days. In all six cases, GX15-070 exhibited potent single agent activity and IC50 values were within clinically achievable concentrations. High BCL-2 expression and low expression of particular BH3-only BCL-2 family mRNAs in this disease correlate with GX15-070 sensitivity in vitro.

"GX15-070 is an appropriate candidate for ALL treatment because the imbalanced expression of Bcl-2 family proteins in this cancer leads to impaired apoptosis," said Gordon Shore, Ph.D., Chief Scientific Officer of Gemin X. "Additionally, this study further upholds what we already have observed about our lead candidate's utility as a single agent and in combination with other therapies."

These data were presented by Dr. Alena Zhang from Dr. Carolyn Felix's laboratory at Children's Hospital of Philadelphia on April 17 at 3:40 PM in an abstract titled, "BCL-2:BH3-only pro-apoptotic gene expression ratios correlate with in vitro sensitivity of primary MLL(+) infant acute lymphoblastic leukemia to small molecule pan-BCL-2 family inhibitor GX15-070."

Gemin X is currently conducting several clinical trials of GX15-070 in multiple cancer types as a combination therapy and as a single agent. Gemin X recently initiated a Phase 1b trial with GX15-070 in combination with bortezomib in patients with mantle cell lymphoma (MCL) and a Phase 1/2 clinical trial in combination with docetaxel in patients with non-small cell lung cancer. GX15-070 is also in Phase 2 clinical trials in patients with Hodgkin's Lymphoma, myelofibrosis with myeloid metaplasia, myelodysplastic syndrome, and follicular lymphoma both as single agent and in combination with rituximab. In multiple Phase 1 studies, GX15-070 was well-tolerated and resulted in clinical and biological activity.

About Acute Lymphoblastic Leukemia

Acute lymphoblastic leukemia (ALL), also known as acute lymphocytic leukemia, is a fast-growing cancer of the white blood cells, which the body uses to fight infections. The disease is characterized by the bone marrow's overproduction of immature, unformed cells called blasts that would normally develop into mature lymphocytes. These abnormal blasts cannot fight infections, grow quickly, and interfere with normal red blood cells, white blood cells, and platelets. Approximately 4,000 new cases of ALL are diagnosed in the United States each year, and it is fatal if left untreated, because the disease can spread to the bloodstream and organs quickly. It mainly appears in children younger than 10, but one-third of cases are in adults. ALL is the most common form of infant leukemia.

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 Montreal, Quebec and Malvern, Pennsylvania. For additional information please visit Gemin X at www.geminx.com