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Gemin X Presents New Data on Obatoclax at the American Society of Hematology Meeting

Company's Novel Oncology Candidate Highlighted in Three Oral and Two Poster Presentations

MALVERN, Pa. & MONTREAL--(BUSINESS WIRE)--Dec 9, 2008 - Gemin X, a clinical stage biopharmaceutical company developing novel, targeted cancer therapeutics, today announced the presentation of new in-vitro data further demonstrating mechanism of action, potential targets and key pathways for the Company's lead oncology product candidate in clinical development, obatoclax (GX15-070). This research is being presented by leading clinical oncology experts in three oral and two poster presentations at the prestigious 50th Annual Meeting of the American Society of Hematology (ASH), being held December 6-9 in San Francisco.

The studies presented at ASH include monotherapy and combination therapy studies with obatoclax against a range of leukemia, lymphoma and mastocytosis cell lines and patient samples. The resulting data further reinforce the pro-apoptotic effect of obatoclax and demonstrate striking synergy between obatoclax and a number of standard cytotoxic agents, including rituximab, in diverse malignancies marked by the up-regulation of Mcl-1, the dominant member of the Bcl-2 family of proteins. Mcl-1 has been shown to have a pro-survival effect in malignant cells; thus inhibition of Mcl-1 with obatoclax could increase the activity of the drug's tumor killing effect. The data presented at ASH also include early findings that demonstrate a second mechanism by which obatoclax may induce cancer cell death – autophagy (controlled self-digestion) – in addition to apoptosis (programmed self-destruction). Together, these data strengthen the scientific foundation of support for obatoclax and highlight the opportunity for broad clinical development of obatoclax across multiple disease areas.

Obatoclax is a potential first-in-class pan Bcl-2 inhibitor that initiates programmed cancer cell death, or apoptosis, and may trigger cancer cell self-digestion, or autophagy, by targeting multiple Bcl-2 related proteins including Mcl-1. Obatoclax is currently in Phase 2 clinical trials as both a single agent and combination therapy.

“We are very enthused by the wide spectrum of new preclinical obatoclax data being presented in both oral and poster presentations at ASH as we continue to expand on our clinical development activities with this program,” said Glenn J. Gormley, M.D., Ph.D., President and CEO of Gemin X. “Our growing body of data supporting obatoclax's mechanism of action and potential synergy with some of today's most widely used cytotoxics strongly positions us to make well-informed and strategic decisions regarding current and future clinical development. These data not only provide support for our active Phase 2 trials of obatoclax in small cell lung cancer and adult myeloid leukemia, but also introduce an opportunity for our accelerated development of obatoclax for the treatment of systemic mastocytosis, a rare and progressive chronic myeloproliferative disorder for which there are very limited treatment options.”

ASH 2008 presentations of obatoclax data include:

Oral Presentations:

 

  • Effects of the Mcl-1/Bcl-2 Inhibitor GX015-070 (Obatoclax®) on Growth and Viability of Canine and Human Neoplastic Mast Cells (861: Tuesday, December 9, 2008, 8:15 a.m.)
  • The BH3-Mimetic Obatoclax (GX15-070) Possesses a Dual-Mechanism of Action and Induces Both Apoptosis and Autophagy-Dependent Cell Death of B Cell Non-Hodgkin's Lymphoma (B-NHL) Cells (605: Monday, December 8, 2008, 4:30 p.m.)
  • CD44 Signaling via PI3K/AKT and MAPK/ERK Pathways Protects CLL Cells from Spontaneous and Drug Induced Apoptosis (541: Monday, December 8, 2008, 1:30 p.m.)

Poster Presentations:

 

  • Pan-Anti-Apoptotic BCL-2 Family Inhibitor, Obatoclax, Activates Autophagic Cell Death Pathway and Has Potent Cytotoxicity in Infant and Pediatric MLL-Rearranged Leukemias (2647: Sunday, December 7, 2008)
  • The Combination of a Histone Deacetylase (HDAC) Inhibitor with the BCL-2 Inhibitor GX15-070 Has Synergistic Antileukemia Effect by Inducing Both Apoptotic and Autophagic Pathways (1633: Saturday, December 6, 2008)

“The combinability and targeted activity exhibited in these early studies of obatoclax is significant and very compelling from a patient care perspective,” said Dr. Francisco J. Hernandez-Ilizaliturri, Assistant Professor and Physician Scientist at the Roswell Park Cancer Institute. “Understanding the different pathways through which obatoclax can stimulate cancer cell death will help in developing its optimal clinical use. I look forward to continuing to work with Gemin X on these promising obatoclax research efforts.”

About Bcl-2 Antagonists and Obatoclax

Bcl-2 derives its name from B-cell lymphoma 2; the Bcl-2 family is a group of proteins that are involved in a number of cancers, including melanoma, breast, prostate and lung carcinomas, and are also thought to be involved in resistance to conventional cancer treatment. The Bcl-2 family is involved in the regulation of apoptosis, a form of cell death.

Obatoclax, Gemin X's small molecule pan Bcl-2 antagonist, is specifically designed to inhibit all relevant members of the Bcl-2 family, including the dominant protein Mcl-1, thus restoring the process of apoptosis. Obatoclax has also shown early activity in inducing cancer cell self-digestion, or autophagy. Obatoclax is currently in multiple Phase 1 and 2 trials.

About Gemin X Pharmaceuticals

Gemin X is developing first-in-class cancer therapeutics based on reinitiating programmed cell death, or apoptosis, inducing cancer cell self-digestion, or autophagy, and the inhibition of metabolism in cancerous cells. Gemin X currently has several clinical development programs underway, including Phase 2 clinical trials for its lead product candidates obatoclax (GX15-070), an innovative pan Bcl-2 inhibitor, and GMX1777, a novel inhibitor of NAD+ synthesis, and preclinical studies for its Telomere Capping and SMAC Mimetic programs. Potential treatment indications for the full scope of pipeline programs span a broad range of hematological and solid tumors, including mantle cell lymphoma (MCL), melanoma, glioblastoma, small cell lung cancer (SCLC), refractory acute lymphoblastic leukemia (ALL) and mastocytosis. Founded in 1998, Gemin X is privately held with drug development and executive headquarters in Malvern, Pennsylvania and drug discovery operations in Montréal, Canada. For more information, please visit www.geminx.com.

 

 

Contact: Pure Communications
Keri P. Mattox, 215-791-0105
keri@purecommunicationsinc.com

 

Posted: December 2008

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