Jump to content

New Vaccine Going into Phase II Trials


Recommended Posts

Epimmune Preparing Phase 2 Study of Cancer Vaccine Based on Positive Initial Human Results

Tuesday September 28, 7:30 am ET

SAN DIEGO, Sept. 28 /PRNewswire-FirstCall/ -- Epimmune Inc. (Nasdaq: EPMN - News) today announced plans for a Phase 2 study of its EP-2101 vaccine in patients with late stage non-small cell lung (NSCL) cancer, based on evidence of relevant biological responses in early clinical trials in both NSCL and colorectal cancer.

Analysis of the data from patients who completed the initial trials showed that EP-2101:

* was immunogenic with approximately 93% of the patients evaluated

responding to at least one epitope included in the vaccine;

* induced a multi-epitope response with approximately four vaccine

epitopes being the average number recognized by the patients evaluated

and approximately 53% of the patients evaluated responding to at least

five of the nine epitopes included in the vaccine; and

* was safe and well tolerated.

The goal of the Phase 2 study will be to correlate overall survival and clinical benefit to patients with the immunogenicity demonstrated in the Phase 1 trials.

The Phase 2 study will be conducted in stage IIIB/IV NSCL cancer patients with advanced disease as a single dose level, open-label study. The primary endpoints will be overall survival and safety. Secondary endpoints will be progression-free survival and vaccine immunogenicity. The study will be conducted by Epimmune in the United States and is expected to involve between 10 and 12 sites and enroll approximately 84 patients. Enrollment is expected to be complete by the end of 2005 and data from the study is expected to be available beginning in the second half of 2006.


Link to comment
Share on other sites

Join the conversation

You can post now and register later. If you have an account, sign in now to post with your account.

Reply to this topic...

×   Pasted as rich text.   Restore formatting

  Only 75 emoji are allowed.

×   Your link has been automatically embedded.   Display as a link instead

×   Your previous content has been restored.   Clear editor

×   You cannot paste images directly. Upload or insert images from URL.

  • Create New...

Important Information

By using this site, you agree to our Terms of Use.