ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) announced today that it held a Type A meeting with the U.S. Food and Drug Administration (FDA) to discuss the complete response letter (CRL) it received in August from the FDA regarding the Company's New Drug Application (NDA) for Exelbine™ (vinorelbine injectable emulsion) for the treatment of non-small cell lung cancer. During the meeting, ADVENTRX discussed with FDA staff all of the items outlined in the CRL, including responses previously submitted by the Company to the FDA during the NDA review and information the Company believes demonstrates the authenticity of the study drugs used in the pivotal bioequivalence study of Exelbine (Study 530-01).
As previously announced, the CRL stated that the authenticity of the study drugs used in Study 530-01 could not be verified. During the meeting, FDA staff indicated that the clinical sites, which were selected in 2006 by a third-party contract research organization, failed to randomly select and retain reserve samples of the test article (Exelbine) and reference standard (Navelbine®) and this deficiency could not be overcome by alternative methods of verifying authenticity and reiterated that the bioequivalence study would need to be repeated.
Additionally, FDA staff commented that no clinical deficiencies were noted with Study 530-01 and that there were no comments regarding the Company's conclusion that Exelbine and Navelbine are bioequivalent based on Study 530-01 data.
"Although we are pleased with the Agency's assessment of the clinical data, we are disappointed it could not exercise discretion in our case to consider other methods of verifying the authenticity of the study drugs," stated Brian M. Culley, Chief Executive Officer of ADVENTRX. "The Agency's assessment of the clinical data gives us confidence that a repeat study would be successful and that Exelbine can be approved. However, although the third-party costs to conduct an additional bioequivalence study and to launch Exelbine are relatively modest, we believe our stockholders are best served by focusing our capital on ANX-188 and ANX-514, which reflect larger market opportunities, and we intend to seek a partner or outside investor for the Exelbine program."
"Our cash and equivalents of $40.7 million at July 31, plus cost savings from discontinuing the Exelbine program, will provide us the capital to advance both our ANX-188 and ANX-514 programs into their respective pivotal clinical studies next year. Additionally, we have taken and will continue to take measures to ensure that our contractors have the qualifications and experience needed to bring new therapies successfully through pivotal studies and make them available to patients," Mr. Culley added.
SOURCE ADVENTRX Pharmaceuticals, Inc.