ZIOPHARM Announces Approval of IND for ZIO-101

ZIOPHARM Announces Approval of IND for ZIO-101 74.7 KB ZIOPHARM Announces Approval of IND for ZIO-101 NEW HAVEN, CT April 5, 2005 - ZIOPHARM, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug Application (IND) for the clinical development of its proprietary organic arsenic compound, ZIO-101. The Company plans to initiate a dose-ranging Phase I trial of ZIO-101 in patients with hematological cancers this month. The trial will be conducted at the University of Texas M.D. Anderson Cancer Center in Houston. "We are very pleased to advance ZIO-101 as our second compound in clinical development and to have met our timeline" commented Mark Thornton, MD, PhD, Head of Product Development and Chief Medical Officer. "This represents an important milestone for ZIOPHARM, and on the basis of encouraging preclinical safety data, we intend to begin treating patients with ZIO-101 at doses approximately 14 times higher than the FDA approved starting dose of inorganic arsenic trioxide. The ability to safely administer substantially higher doses of a potent arsenical may offer opportunities for wider therapeutic use, not only within the family of blood cancers, but in solid tumors as well." Dr. Thornton continued, "With respect to our other compound in clinical development, ZIO-201, the small molecule stable active metabolite of ifosfamide, our Phase I trial is progressing well at the Karmanos Cancer Center in Detroit. We look forward to data from both the ZIO-101 and ZIO-201 Phase I programs during this year." About ZIOPHARM, Inc. ZIOPHARM is a privately held company and was founded in January 2004 to develop and commercialize a diverse, risk-sensitive portfolio of in-licensed cancer therapies. All products are focused on addressing unmet medical needs, with the potential for expedited regulatory approval and broad usage. 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 is anticipated to begin in the second half of this year. 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 is expected to initiate in the second half of this year. 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

The release as fetched from its publisher. alaunos.com ↗