Closed Phase 2 Clinical Trials
Specifid Following Rituxan
We initiated a Phase 2 clinical trial of Specifid™ (formerly FavId®) in patients with follicular B-cell non-Hodgkin's lymphoma who were candidates for Rituxan® therapy in June 2002. Initially, this trial was limited to relapsed or refractory patients who had previously undergone treatment with Rituxan, chemotherapy or both. In April 2003, we expanded the entry criteria for this trial to include patients with no prior treatment for their lymphoma.
The open-label Phase 2 trial was conducted at 20 sites. Enrollment in this trial was completed in December 2003. A total of 103 patients were enrolled, of which 89 had stable disease or a better response to Rituxan and received Specifid, including 55 who were relapsed from or refractory to prior treatments and 34 who were treatment-naïve.
Specifid as a Single Therapeutic Agent
In September 2002, we completed enrollment of a Phase 2 clinical trial evaluating Specifid as a single therapeutic agent in indolent B-cell non-Hodgkin’s lymphoma patients who were either relapsed from or refractory to prior treatments. The trial was conducted at multiple sites and was designed to determine whether use of Specifid alone could stimulate an immune response and whether this response would result in a clinical benefit.
Data from this trial were published in the July 1, 2006 issue of the Journal of Clinical Oncology. The article concludes that Specifid as a single agent is active and well tolerated in previously treated and relapsed patients with indolent B-cell NHL. Results from this multi-center trial demonstrated a median time to disease progression for the 31 evaluable patients in the trial of 13.5 months. The most common adverse events reported were mild to moderate injection site reactions.
Specifid Following Autologous Stem Cell Transplant (enrollment complete)
Patient enrollment for a physician-sponsored Phase 2 clinical trial evaluating Specifid in patients with indolent B-cell non-Hodgkin's lymphoma following autologous stem cell transplantation began in November 2000. Autologous stem cell transplantation involves the removal of important blood cells from a patient before the patient receives large doses of chemotherapy. After chemotherapy, the blood cells are returned to the patient to speed recovery from the chemotherapy treatment. This trial was conducted at two sites.
This trial was designed to evaluate the ability of Specifid to induce humoral and cell-mediated immune responses, and to induce or maintain complete clinical or molecular remission, following autologous stem cell transplantation. In addition, the trial evaluated the correlation of specific T-cell populations with immune responsiveness to Specifid, as well as the safety of Specifid following autologous stem cell transplantation.
After we obtained tumor cells via biopsy from each patient to establish the genetic profile of the tumor for our use in manufacturing the patient’s Specifid, patients underwent autologous stem cell transplantation using standard regimens. At three months following transplantation, patients received the first of five monthly injections of Specifid. Patients were assessed at fixed intervals for safety, development of immune responses to their tumor idiotype, and for evidence of molecular remissions.
Specifid with Maintenance Rituxan
Patient enrollment for a multi-center, physician-sponsored Phase 2 clinical trial evaluating Specifid™ (formerly FavId®) in combination with maintenance Rituxan® began in May 2004. We assumed sponsorship of the trial in August 2004. The trial was open to treatment-naïve patients with indolent B-cell non-Hodgkin's lymphoma and was expected to enroll a total of 56 patients.
This trial was designed to evaluate the safety of this regimen and to assess its efficacy based on response rate and event-free survival. We obtained tumor cells via biopsy from each patient to establish the genetic profile of the tumor for our use in manufacturing the patient's Specifid. In addition, a CT scan was conducted in order to measure tumor burden before the start of Rituxan treatment.
Patients received the same dose and schedule of maintenance Rituxan as was administered in the prior trials of maintenance Rituxan, which consisted of a standard course of Rituxan weekly for four weeks followed by maintenance Rituxan at six month intervals. Specifid was incorporated into this treatment regimen starting on the third month and was administered monthly for the first 12 months, every other month for the second 12 months and every three months thereafter. Specifid was not administered during those months when patients receive Rituxan. With each Specifid administration, GM-CSF was administered on four consecutive days beginning on the day of such Specifid administration.
Specifid in Non-Follicular B-cell NHL
Patient enrollment for a physician-sponsored Phase 2 clinical trial evaluating Specifid in patients with non-follicular B-cell non-Hodgkin's lymphoma was initiated in Europe in June 2005. The trial was open to patients with various non-follicular lymphomas who were either treatment-naïve for their lymphoma, relapsed or refractory following prior chemotherapy for their lymphoma or relapsed following a prior response to Rituxan. The trial was expected to enroll 15 patients.
This trial was designed to evaluate the efficacy of Specifid in patients with non-follicular indolent non-Hodgkin's lymphoma based on overall response rate, duration of response, time to progression and event-free survival.
Specifid was administered monthly for the first six months, every other month for the next 12 months, and every three months thereafter until disease progression. With each Specifid administration, GM-CSF was administered on four consecutive days beginning on the day of such Specifid administration.