Speaking at the Bank of America Merrill Lynch 2013 Health Care Conference held last month, Vijay Samant, President and CEO of Vical (VICL) noted "We have two programs under CMV, one is for prevention of reactivation of CMV in transplant patients, first in hematopoietic cell transplant and second in solid organ transplant, both important market segments, and then the second component of the program really is the large commercial opportunity." At the time, Samant expected the Phase III study of its TransVax therapeutic vaccine involving recipients undergoing allogeneic, hematopoietic cell transplant (HCT) to begin in the first half of 2013.
I covered the results of the Phase II proof-of-concept trial for its TransVax vaccine early in 2012.
Now, in an announcement that has just appeared on the FDA's Clinical Trials Web site (ClinicalTrials.gov Identifier: NCT01877655), Astellas Pharma Global Development, a U.S. affiliate of Tokyo-based Astellas Pharma (OTCPK:ALPMY), with whom Vical is collaborating, stated the details for the HCT study. According to the information on the Web site, the purpose of the study is to determine if overall mortality is affected one year after a hematopoietic stem cell transplant HCT in patients given a vaccine to prevent cytomegalovirus (CMV). The safety of Vical's therapeutic vaccine ASP0113 in subjects undergoing allogeneic HCT will also be evaluated.
The study, which is not yet open for recruitment, is divided into two parts. Part 1 will include the first 100 subjects, who will be randomized. The purpose of Part 1 is to collect efficacy results to evaluate treatment effect on the primary endpoint and other efficacy endpoints to potentially modify the primary endpoint for being specified for Part 2 of the study. Part 2 will include the subsequent 400 subjects to evaluate the vaccine efficacy on the incidence of the primary endpoint through one year post-transplant. The study will run through September 2016.
Importantly, Astellas is responsible for all costs associated with the trial.
The daily chart for Vical, courtesy StockChart.com, shows the stock falling with the general market, which is reacting to the Fed signaling it soon will turn off the easy money spigot. On the positive side, however, note the stock is coming off an oversold condition (rising Relative Strength) and the Daily MACD has just turned positive, indicating the smart money is returning to the issue.
The weekly chart for Vical shows the stock trapped in a broad flag pattern dating to the start of 2011. The Relative Strength is nearing oversold conditions while the Weekly MACD is negative.
Additional disclosure: I am long VICL. I am not a registered investment advisor and do not provide specific investment advice. The information contained herein is for informational purposes only. Nothing in this article should be taken as a solicitation to purchase or sell securities. Before buying or selling any stock you should do your own research and reach your own conclusion. It is up to investors to make the correct decision after necessary research. Investing includes risks, including loss of principal.