Key Developments For Opexa Therapeutics, Inc.
Opexa Therapeutics, Inc. (OPXA.O) (Consolidated Issue listed on NASDAQ Capital Market)
Opexa Therapeutics Inc. Announces Additional Favorable Data With Tovaxin For Multiple Sclerosis
Opexa Therapeutics Inc. announced results from further analysis of the double-blind, placebo-controlled, 52-week Phase IIb TERMS clinical study of 150 patients with Relapsing Remitting MS (RRMS). This analysis evaluated patients with an annualized relapse rate of one or greater at study entry (ARR?1). More than 83% of the Tovaxin-treated group (n=85) remained relapse free at one year and the annualized relapse rate after treatment decreased to 0.20, a 42% reduction compared to placebo. The results of this expanded analysis confirm those found in the previously-reported per-protocol analysis of patients in the TERMS study with ARR>1. This post-hoc analysis which represents 86% of the total patient population in the TERMS study was conducted to evaluate Tovaxin treatment among study patients with the same baseline disease activity that is being targeted for inclusion in the forthcoming Phase IIb study. Along with a marked reduction in relapses, 73% of the Tovaxin-treated patients with ARR?1 showed stabilization or improvement in MS disability, including 16.5% with a sustained improvement in the Expanded Disability Status Scale (EDSS) of at least one full point. On MRI, the Tovaxin-treated group also demonstrated a reduction in brain atrophy and fewer inflammatory brain lesions that progressed to black holes, as compared to the placebo-treated group. Treatment with Tovaxin was well tolerated, with no serious adverse events reported in any Tovaxin-treated patient.
Novartis AG Acquires Opexa Therapeutics Inc.'s Stem Cell Technology-Reuters
Reuters reported that Opexa Therapeutics Inc. said that Novartis AG has acquired its stem cell technology, which was in early preclinical development. Under the agreement, Opexa will receive an upfront cash payment of $3 million, plus an additional $1 million as a technology transfer fee to be paid over the course of a six month period. Total payments to Opexa, including the upfront payment, the technology transfer fee and development and commercial milestone payments could exceed $50 million not including royalties. Opexa said it is also eligible to receive royalty payments from the sale of any products resulting from the use of the technology and retains an option on certain manufacturing rights. Opexa also said it assigned the license agreement it had entered into with the University of Chicago, to Novartis.
Opexa Therapeutics Inc. Announces Stem Cell Agreement With Global Pharmaceutical Company
Opexa Therapeutics Inc. announced that it has entered into an exclusive agreement with Novartis, for the further development of Opexa`s novel stem cell technology. This technology, which has generated preliminary data showing the potential to generate monocyte derived islet cells from peripheral blood mononuclear cells, was in early preclinical development at Opexa. Under the terms of the agreement, Novartis will acquire the stem cell technology from Opexa and Novartis will have full responsibility for funding and carrying out all research, development and commercialization activities. Opexa will receive an upfront cash payment of $3 million, plus an additional $1 million as a technology transfer fee to be paid over the course of a six month period. Total payments to Opexa, including the upfront payment, the technology transfer fee and development and commercial milestone payments could exceed $50 million not including royalties. Opexa is also eligible to receive royalty payments from the sale of any products resulting from the use of the technology and retains an option on certain manufacturing rights.
Opexa Therapeutics Inc. Announces Tovaxin Clinical Data
Opexa Therapeutics Inc. announced data from its Phase I/II dose escalation study in the May 2009 edition of the Journal of Clinical Immunology. Encouraging data from this clinical study paved the way for the larger Phase IIb TERMS trial that was completed in late 2008. This small dose finding study of Tovaxin, Opexa`s T cell vaccine in development for MS, enrolled patients with relapsing-remitting MS or secondary progressive MS who had failed or were intolerant of currently approved MS therapies. The study was designed to find a safe and effective Tovaxin dose. Tovaxin immunization resulted in rapid depletion of circulating myelin-reactive T cells (MRTC), with an observed dose-response effect. A safe and effective dose was identified for further clinical trials, associated with reductions in MRTC ranging from 92% at week 5 to 65% at week 52. Clinically, using the per-protocol criteria for MS relapses, a statistically significant reduction in relapse rate (85%, p<0.05) was seen among the 10 evaluable patients, and a 63% reduction was demonstrated in the modified intent-to-treat population. The MRI lesions were stable and there was an improving trend in disability as measured by the expanded disability status scale and patients’ physical score as measured by the Multiple Sclerosis Impact Scale, following the second injection.
Opexa Therapeutics Inc. Closes First Tranche Of Additional Financing
Opexa Therapeutics Inc. announced the closing of an initial tranche of a private offering of secured convertible notes and warrants for gross proceeds of approximately $1.1 million. Opexa will use the proceeds from the financing to support the ongoing partnering discussions for both its Tovaxin T-cell program and its stem cell platform. Participating in the financing were existing shareholders, consisting of institutional investors, private individuals and members of Opexa`s Board of Directors. The initial tranche of a private placement of $1.1 million of secured convertible notes maturing in April 2011 closed on April 14, 2009. The notes accrue interest at a 10% rate, compounded annually, and the interest is payable at maturity in either cash or common stock at the Company's option. The notes are secured by substantially all of the Company's assets and are convertible into common stock, at the option of the holders, at a price of $0.50 per share. Additionally, subject to the satisfaction of certain conditions, the notes are mandatorily convertible into common stock, at the Company's option, during their term also at $0.50 per share. The warrants have a four year term and are exercisable for 50% of the number of shares that the note is convertible into at an exercise price of $0.75 per share. Cambria Capital, LLC assisted with the placement of a portion of the private offering.
