By Brady Huggett
The Immune Response Corp. released both positive and negative news Thursday for its HIV product with an oscillating trial-result history, Remune, saying it is dropping a pivotal trial and that a previously reported failed Phase II trial, completed in Spain, was actually a success.
The news did little to influence Wall Street, however, as Immune Reponse¿s stock (NASDAQ:IMNR) fell 9 cents Thursday to close at $2.09. But there were plenty of good vibes in Carlsbad, Calif., where Immune Response makes its home.
¿We are very excited about this ¿ it¿s the first time in the last 20 years a therapeutic has shown it reduced viral load,¿ said Dennis Carlo, CEO and president of Immune Response. ¿We¿ve shown this in prospective studies, but in this case it was the primary endpoint.¿
The reversal of results in the Phase II trial comes about through the further analysis of data by an independent Data Safety Monitoring Board. Originally, the board found no significant difference between the treated group and the control group, and the trial was deemed a failure. Immune Response¿s stock suffered more than a 55 percent loss on that news. (See BioWorld Today, June 4, 2001.)
The board reconvened, reanalyzed, and the trial went from failure to success.
¿The [monitoring board] had met and at that time suggested there was some efficacy in subgroups of patient,¿ said Ronald Moss, vice president, medical and scientific affairs at Immune Response. ¿They requested additional information. When the appropriate analysis was done, the additional information suggested that we did hit the primary endpoint.¿
The new data included an intent-to-treat analysis and complete follow-up time of all patients. Along with three outside statisticians, the board agreed that the most appropriate primary analysis was the Cox regression model stratified by baseline viral load in an intent-to-treat analysis. Thus agreed, the board said the study met its primary endpoint and showed a positive impact on controlling virus (p=0.034).
The news again pumps life into a volatile Remune program with a history of both setbacks and surges. In the spring, the company said it would publish in a European journal that Remune reduces vial load regardless of concomitant antiretroviral drug therapy; its stock rose 58 percent, or 95 cents. Then came the failed Phase II in Spain and the stock drop of about 55 percent, followed by a return of Remune rights in July by Immune Response¿s partner, Agouron Pharmaceuticals Inc., a New York-based Pfizer Inc. company. (See BioWorld Today, April 24, 2001, and July 9, 2001.)
Thursday¿s news that Immune Response would not continue with the pivotal trial called Study 202 came after the company viewed data provided by Agouron.
¿Agouron dropped out [of the collaboration in July],¿ Carlo said. ¿They gave us the information on the 202 study and they were going to transition it to us. We decided, when we looked at it, it was not fully enrolled and the power really wasn¿t there. They really underpowered the study. They were paying for it, and once we looked at the numbers we decided we shouldn¿t take it over.¿
The next move for Immune Response is packaging the data and considering how to move ahead.
¿We are putting all the data together and will publish the work in the next couple of months,¿ Carlo said. ¿We will go to the regulatory authorities and see what is next for Europe and the U.S.¿
Immune Response had about $13 million in cash as of June 30, Carlo said. It lost about $5.3 million in the second quarter, pointing to a need for funds in the not-too distant future. Carlo addressed those concerns.
¿We are looking to partner Remune and partner a couple of other programs we have in house in autoimmune diseases and cancer,¿ he said, adding that news on that front should be released sometime in the next few months. Carlo said Immune Response is ¿actively talking¿ to potential partners and ¿a number¿ of companies have shown interest.
The company has a therapeutic vaccine for arthritis that has finished a Phase II study, products for multiple sclerosis and psoriasis that have completed Phase I, and a cancer vaccine in Phase I trials. It also has a preclinical cancer vaccine program.
With some trial baggage cut and a turnaround on the trial in Spain, it¿s a new day for Immune Response.
¿It¿s a positive trial ¿ it met its primary endpoint,¿ Carlo said, referring to the reanalyzed Phase II study. ¿I look at this data today and it¿s too bad Jonas Salk is not alive because this was his dream. We have shown an effect on the virus and there is no other therapeutic that has shown that in the 20-year history of the disease. This is the most important point in the company¿s lifecycle.¿