Dendreon Corp fka DNDNQ

[libertyhound]

This relates to 'BiovaxID' produced by 'Biovest International (BVTI.OB)...apparently P-3 results due by May 1st..

What do you guys make of this?

Full article: http://jnci.oxfordjournals.org/cgi/content/full/98/18/1292

ABSTRACT


Background: Follicular lymphoma is considered incurable, although cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy can induce sequential remissions. A patient's second complete response is typically shorter than that patient's first complete response. Idiotype vaccines can elicit specific immune responses and molecular remissions in patients with follicular lymphoma. However, a clinical benefit has never been formally proven. Methods: Thirty-three consecutive follicular lymphoma patients in first relapse received six monthly cycles of CHOP-like chemotherapy. Patients who achieved a second complete response were vaccinated periodically for more than 2 years with autologous lymphoma-derived idiotype protein vaccine. Specific humoral and cellular responses were assessed, and patients were followed for disease recurrence. Statistical tests were two-sided. Results: Idiotype vaccine could be produced for 25 patients who had a second complete response. In 20 patients (80%), a humoral (13/20) and/or a cellular (18/20) idiotype-specific response was detected. The median duration of the second complete response has not been reached, but it exceeds 33 months (range = 20+ to 51+ months). None of the 20 responders relapsed while undergoing active vaccination. All responders with enough follow-up for the comparison to be made experienced a second complete response that was statistically significantly (P<.0001) longer than both their first complete response (18 of 18 patients) and than the median duration of a CHOP-induced second complete response, i.e., 13 months (20 of 20 patients). The five nonresponders all had a second complete response that was shorter (median = 10 months; range = 8–13 months) than their first complete response (median = 17 months; range = 10–39 months). Conclusions: Idiotypic vaccination induced a specific immune response in the majority of patients with follicular lymphoma. Specific immune response was associated with a dramatic and highly statistically significant increase in disease-free survival. This is the first formal demonstration of clinical benefit associated with the use of a human cancer vaccine.

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INTRODUCTION


Follicular lymphoma is an indolent B-cell malignancy for which no treatment has proved consistently curative (1). A number of conventional therapeutic options can induce relatively durable and sequential clinical complete responses in the vast majority of patients (2). However, second and subsequent responses tend to be progressively shorter than those achieved previously (2,3). In particular, most second complete responses obtained through standard chemotherapy (such as monthly treatment with the cyclophosphamide, doxorubicin, vincristine, and prednisone [CHOP] regimen) last far less than 2 years, and the median duration is 13 months (4,5).
Several immunotherapeutic approaches to treatment of follicular lymphoma are currently under investigation (6). One is idiotype vaccination, which is based on the fact that the immunoglobulin on the surface of each patient's cancer cells contains a unique idiotype protein that can serve as a tumor-specific antigen (7). Over the past 15 years, idiotype vaccines have proved capable of eliciting both humoral (8–10) and cellular (9–10) idiotype- and tumor-specific responses in a variable percentage of patients with follicular lymphoma, particularly when used to consolidate a chemotherapy-induced first complete response (9,11). Some of these immune responses have been found to translate into molecular remissions, with circulating follicular lymphoma cells positive for Bcl-2/IgH rearrangements no longer detectable in patients in whom standard chemotherapy had achieved only clinical complete response (9,12). These results are consistent with those of a recent study that found that tumor-associated T-cell infiltration may influence clinical progression of follicular lymphoma (13). However, no formal proof of the clinical efficacy of idiotype vaccination has emerged (10). Evaluation of the efficacy of a customized patient-specific intervention is a challenge for conventional randomized trial methodology because it is difficult to make valid comparisons when the experimental intervention is unique to each patient (14).

In what is, to our knowledge, the largest and most homogeneous series of follicular lymphoma patients in first relapse treated with standard chemotherapy plus idiotypic vaccination, we investigated the association between the ability of a soluble protein idiotype vaccine to induce any idiotype- and/or tumor-specific immune response and the objective extension of relapse-free survival in follicular lymphoma patients. In addition to systematically monitoring both vaccine-induced immune responses and minimal residual disease in all vaccinated patients, we also compared the outcome of each patient's first and second complete response, so that each patient could effectively serve as his or her own matched control subject.


PATIENTS AND METHODS


Study Participants

Between October 1, 2001, and June 30, 2004, 33 consecutive patients with..... **full article link:

http://jnci.oxfordjournals.org/cgi/content/full/98/18/1292