Dec 8 2014
Henry Ford Hospital today announced that it is actively recruiting patients to participate in a clinical trial taking place at the Hermelin Brain Tumor Center which is showing promising results in patients with brain cancer.
In an interim analysis, the study showed increased median overall survival and progression-free survival at six months relative to historical benchmarks for patients suffering a recurrence of high grade glioma (HGG) who were treated with a combination gene therapy, Toca 511 & Toca FC. Data from the trial, sponsored by Tocagen, Inc., were presented at the 19th Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology.
HGG tumors include glioblastoma, the most common and deadliest form of brain cancer, which typically recurs within months of standard therapy.
In the ongoing study, 34 patients with recurrent HGG had Toca 511 administered into the portion of the brain from which the tumor was removed during surgery followed by cycles of orally administered Toca FC. Median overall survival was 52 weeks compared with the historical benchmark of 32 weeks.
In addition, 19 patients with recurrent glioblastoma who had two or fewer prior recurrences had a median overall survival of 59 weeks, compared to the benchmark of 33 weeks. Six-month progression-free survival for patients with glioblastoma was 27 percent compared to 10 percent for historical published data.
The presented data with the most relevant historical benchmarks are summarized in the table below:
"These results are extremely encouraging, especially for brain cancer, an aggressive and deadly disease," said Steven Kalkanis, M.D., co-director of the Hermelin Brain Tumor Center at Henry Ford, the site of the first patient dosed in the clinical trial.
"We look forward to continuing to enroll patients in this and other studies involving Toca 511 & Toca FC so we can continue to advance this promising therapy into late-stage development."
Added Tom Mikkelsen, M.D., co-director of the Hermelin Brain Tumor Center at Henry Ford, "This promising therapy represents a radically different approach to killing virulent brain cancer, and offers hope for improving the current prognosis while minimizing side effects."
Similar clinical trials for patients with HGG are also taking place at Henry Ford Hospital, specifically involving administration of Toca 511 directly into the tumor as well as intravenously and then again into the resection cavity wall at the time of tumor removal.
After allowing time for Toca 511 to spread through the tumor, each patient begins cycles of oral Toca FC tablets for up to six months. After this period, Toca FC cycles can be continued in a follow-up study. MRI scans are performed to measure the treatment's effectiveness. To date, over 78 patients have participated in these trials.
The investigational treatment combines Toca 511 (vocimagene amiretrorepvec), a biologic drug, with Toca FC, an extended-release tablet containing the antifungal flucytosine.
According to Tocagen, Toca 511 & Toca FC is proposed to have a dual mechanism of action. Toca 511 selectively delivers to cancer cells the genetic instructions to produce the cytosine deaminase (CD) enzyme, which can then convert the orally administered Toca FC given in cycles into the powerful anti-cancer drug 5-FU inside the cancer cells. In animal models, the production of 5-FU locally kills dividing tumor cells during each 5-FC cycle, which leads to durable and selective anticancer immune responses.
Henry Ford Hospital is enrolling patients in clinical trials involving this investigational therapy. To be eligible, patients must be at least 18 years old and have a single tumor that has recurred or progressed following surgery, radiation and chemotherapy.
SOURCE Henry Ford Health System
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