Racing Against the Clock

A board to discuss Tcelna as a treatment for Multiple Sclerosis

Racing Against the Clock

Postby notasperfectasyou » Thu Oct 23, 2008 8:45 am

Disclosure: While Kim is on ABX, I have been vouyeristicly interested in Tovaxin and have been hoping for it’s success. I even invested in the stock, which I still have.

Opexa released a 10-Q today. The 10-Q is a report that public companies are required to submit to the securities and exchange commission. There are often some interesting nuggets of knowledge in these reports and I thought folks here might be interested in what Opexa had to say.

Here are a few quotes:

In a one-year, 8-subject extension clinical trial of relapsing remitting and secondary progressive multiple sclerosis subjects, the "per-protocol" analysis of Tovaxin therapy achieved a 92% (p=0.0078) reduction ARR in subjects who received two treatment doses of 30-45 x 106 attenuated T-cells eight weeks apart and were monitored for an additional 44 weeks. Subjects in the extension study had previously been treated an average of approximately 5 years earlier at Baylor College of Medicine under the direction of the inventor of Tovaxin Jingwu Zhang, M.D., Ph.D with an early version of the T-cell vaccine.
An analysis of the second year open-label clinical retreatment studies of the "intent to treat" population of 22 patients who participated in the Phase I/II studies showed that, as a group, 73% remained relapse free after two years and 86% demonstrated no worsening of disease (27% of these showed sustained improvement). Additionally, there was an overall decrease in the ARR of 82% (from 1.38 to 0.21 relapses/patient/year). Each of these endpoints was compared to the patient's own baseline reading, taken prior to enrollment in the trials.
We recently completed a Phase IIb study in 150 patients in a multi-center, randomized, double blind, and placebo-controlled study in patients with relapsing remitting multiple sclerosis or clinically isolated syndrome. Top-line results from the study demonstrated a positive trend in the reduction in annualized relapse rate (ARR) for patients treated with Tovaxin as compared to placebo. However, this finding did not achieve statistical significance. In addition, the study did not achieve statistical significance with its primary endpoint, the cumulative number of gadolinium-enhanced brain lesions.
Top-line results from the study showed that Tovaxin-treated patients experienced an ARR of 0.214 as compared to 0.339 for placebo-treated patients. Despite the low relapse rate in the placebo arm, this still represented a 37 percent decrease in ARR for Tovaxin as compared to placebo in the general population. Additionally, in the group of patients who had an ARR > 1 in the one year prior to study entry, Tovaxin demonstrated a 55 percent reduction in ARR compared to placebo.

As an accountant, I went looking for this:
Net Sales. We recorded no sales for the nine months ended September 30, 2008 and 2007.
Research and Development Expenses. Research and development expense was approximately $7.1 million for the nine months ended September 30, 2008, compared to approximately $10.1 million for the nine months ended September 30, 2007. The decrease in expenses was primarily due to a decrease in activities related to the Phase IIb clinical trial for Tovaxin in 2008 as compared to 2007 and a reduction in stock compensation expense recorded in 2008.
General and Administrative Expenses. Our general and administrative expense was approximately $2.7 million for the nine months ended September 30, 2008, as compared to approximately $2.6 million for the nine months ended September 30, 2007. The increase in expenses is primarily due to an increase in stock compensation expense during the current period.

Which I combine with this:
Liquidity. Historically, we have financed its operations primarily from the sale of its debt and equity securities. As of September 30, 2008, we had cash and cash equivalents of approximately $4.0 million.

To arrive at the conclusion that Opexa has about 4 months +/- to go unless they figure out how to get a huge infusion of cash/support. I’m not saying this to be negative, I’m saying this to let folks know that there needs to be a sense of urgency at Opexa about getting something to happen. I suspect that the “something” might be pushing for Phase III or finding a new deep pocket. The difficulty with that is that the record for financial performance is not good and will weigh heavy on anyone thinking about providing more financing to Opexa. I hope this works out for Opexa, but the timing needs to be soon, very soon. Ken
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