Press Release
ZIOPHARM Starts Phase I Study of ZIO-101
CHARLESTOWN, MA May 19, 2005 - ZIOPHARM, Inc. announced dosing of the first patient in its phase I study of the safety and dosing of ZIO-101, the Company's proprietary small molecule organic arsenic. The study, in up to 40 patients with diverse blood and bone marrow cancers, started on schedule just nine months after the Company licensed ZIO-101 and related compounds from The University of Texas M. D. Anderson Cancer Center. Dr. Steven M. Kornblau at M. D. Anderson is the study leader.
ZIO-101 is the first compound from a family of novel organic arsenics. The Company's Investigational New Drug application was approved in April, 2005. Preclinical evidence suggests that because of the potential for much higher doses and pharmacokinetic differences between organic and inorganic arsenics, ZIO-101 may be active in a broad range of cancers.
"Seeing ZIO-101 enter the clinic is an exciting development for ZIOPHARM and me," commented Hagop Kantarjian, MD, Chairman, Department of Leukemia at M. D. Anderson. Srdan Verstovsek, MD, also at M. D. Anderson, noted, "Having discovered this drug, along with Dr. Ralph Zingaro, my colleagues and I are very excited about ZIO-101's potential to treat blood and bone marrow cancers. We are pleased ZIOPHARM has moved rapidly to bring ZIO-101 to the clinic."
Safety and dosing of ZIO-101 will also be tested in a second phase I study in solid cancers that ZIOPHARM expects to begin in another month at M. D. Anderson. The Company's second clinical-stage compound, ZIO-201, is in an ongoing phase I safety and dose ranging study at the Karmanos Cancer Center in Detroit and a second site will soon be added to that trial.
"With two products in the clinic so soon after initiating operations, ZIOPHARM is delivering on its strategy to deliver novel therapies in a timely fashion to clinicians and their patients with cancer," commented Jonathan Lewis, MD, PhD, CEO of ZIOPHARM. "We expect this milestone to be the first of many in the clinic this year."
About ZIOPHARM, Inc.
ZIOPHARM is a privately held specialty cancer company. Operations were initiated in January 2004 with the strategy of in-licensing proprietary drug candidate families with prior "related-molecule" efficacy in human cancer that would be efficiently and effectively developed and commercialized by a very experienced management team supported by prominent clinicians and medical advisors.
The Company's first in-licensed product in August of 2004, ZIO-101 or organic arsenic, is a small molecule from The University of Texas M. D. Anderson Cancer Center and Texas A&M University. A second organic arsenic from that broad licensing arrangement, ZIO-102, is expected to undergo further preclinical study this year as ZIO-101 progresses through phase I study in both hematologic and solid tumor cancers. A phase I/II trial of ZIO-101 in advanced myeloma is anticipated to begin in the second half of this year with a planned registration trial to begin in the second half of 2006.
ZIO-201, or proprietary IPM (isophosphoramide mustard), is a small molecule licensed in November of 2004 from DEKK-Tec of New Orleans and is currently in phase I study in patients with late-stage cancers at the Karmanos Cancer Center in Detroit. A phase I/II trial and two phase II trials are expected to initiate in the second half of this year with a registration trial also scheduled to initiate in the second half of 2006. As announced in January 2005, the Company is conducting preclinical research with IPM analogs in collaboration with Southern Research Institute under its Collaboration and Option Agreement with the objective of establishing a ZIO-202 clinical candidate.
Forward-Looking Safe Harbor Statement:
This press release contains forward-looking statements for ZIOPHARM Oncology, Inc. that involve risks and uncertainties that could cause the Company's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties, which could cause actual outcomes and results to differ materially from these statements. Among other things, there can be no assurance that any of the Company's development efforts relating to its product candidates will be successful, or such product candidates will be successfully commercialized. Other risks that affect forward-looking information contained in this press release include the possibility of being unable to obtain regulatory approval of the Company's product candidates, the risk that the results of clinical trials may not support the Company's claims, and the Company's reliance on third parties to develop its product candidates. The Company assumes no obligation to update these forward-looking statements, except as required by law.
Contact:
Dr. Jonathan Lewis
Chief Executive Officer
203 848 3400
