Momentum Players

[jaybird249]

AGEN $1.1 + $.16 DNDN like results
AGEN has a cancer vaccine called Oncophage. Results blow DNDN away. Oncophage increased survival by 70%. Provenge increased survival by only 23%. Results to be presented May 20 easy 50% gain IMO
Conference website:

http://www.braintumor2010.de/call.html

Introduction: Autologous heat shock protein vaccine HSPP C-96 (Oncophage®) is derived from a patient’s
individual tumor and contains glycoprotein-96 (gp96) polypeptide associated with cancer-specific antigenic
peptides. HSPP C-96 has been shown to elicit innate and adaptive immune response in patients with recurrent
glioma. In ongoing investigations, we evaluated the use of HSPP C-96 for treatment of Recurrent Glioblastoma
Multiforme (GBM) and in combination with chemotherapy in patients with Newly Diagnosed GBM.
Materials and Methods:Two ongoing, phase 2, open-labeled investigations designed to evaluate clinical
efficacy and immunologic response of HSPP C-96 treatment in patients with recurrent GBM (multi-center
investigation) and newly diagnosed GBM (single-center investigation). Patients with recurrent GBM receive
HSPP C-96 treatment within 5 weeks post-surgery and patients with newly diagnosed GBM are treated with
concurrent HSPP C-96 and temozolomide following surgery and standard of care radiation and temozolomide
therapy.

Results: HSP vaccine was well tolerated with no serious adverse events attributable to vaccine and no related
grade 3 or 4 toxicities. In patients with recurrent GBM (n=32) the overall median survival approximated 44
weeks post-resection and the majority (94%) of patients survived beyond the historical median of 26-weeks.
Approximately 70% of patients survived beyond 36 weeks and 41% survived up to or longer than 1-year. All patients
with immunological endpoints tested to date exhibited a significant innate immune response following
vaccine administration and 92% of patients demonstrated CD8 T cell IFN gamma production upon restimulation with recombinant gp-96 (p<0.01). The majority of patients (92%) exhibited significant Th1 type responses
as measured by multi-cytokine qPCR. The presence of an adaptive immune response and minimal residual
disease was associated with survival beyond 36 weeks. In patients with newly diagnosed GBM (n=8; trial
initiated 2009), there have been no significant toxicities associated with concurrent treatment of HSPP C-96
and temozolomide. Clinical and immunologic evaluation is ongoing.
Conclusions: HSPP C-96 is safe for patients with recurrent glioma and appear to be safe with concurrent
treatment with chemotherapy. HSPP C-96 evokes a specific and innate immune response in patients with
recurrent glioma and survival data available to date indicates HSPP C-96 vaccine provides a possible clinical
benefit with a favorable safety profile.

Introduction: Autologous heat shock protein vaccine HSPP C-96 (Oncophage®) is derived from a patient’s
individual tumor and contains glycoprotein-96 (gp96) polypeptide associated with cancer-specific antigenic
peptides. HSPP C-96 has been shown to elicit innate and adaptive immune response in patients with recurrent
glioma. In ongoing investigations, we evaluated the use of HSPP C-96 for treatment of Recurrent Glioblastoma
Multiforme (GBM) and in combination with chemotherapy in patients with Newly Diagnosed GBM.
Materials and Methods:Two ongoing, phase 2, open-labeled investigations designed to evaluate clinical
efficacy and immunologic response of HSPP C-96 treatment in patients with recurrent GBM (multi-center
investigation) and newly diagnosed GBM (single-center investigation). Patients with recurrent GBM receive
HSPP C-96 treatment within 5 weeks post-surgery and patients with newly diagnosed GBM are treated with
concurrent HSPP C-96 and temozolomide following surgery and standard of care radiation and temozolomide
therapy.

Results: HSP vaccine was well tolerated with no serious adverse events attributable to vaccine and no related
grade 3 or 4 toxicities. In patients with recurrent GBM (n=32) the overall median survival approximated 44
weeks post-resection and the majority (94%) of patients survived beyond the historical median of 26-weeks.
Approximately 70% of patients survived beyond 36 weeks and 41% survived up to or longer than 1-year. All patients
with immunological endpoints tested to date exhibited a significant innate immune response following
vaccine administration and 92% of patients demonstrated CD8 T cell IFN gamma production upon restimulation with recombinant gp-96 (p<0.01). The majority of patients (92%) exhibited significant Th1 type responses
as measured by multi-cytokine qPCR. The presence of an adaptive immune response and minimal residual
disease was associated with survival beyond 36 weeks. In patients with newly diagnosed GBM (n=8; trial
initiated 2009), there have been no significant toxicities associated with concurrent treatment of HSPP C-96
and temozolomide. Clinical and immunologic evaluation is ongoing.
Conclusions: HSPP C-96 is safe for patients with recurrent glioma and appear to be safe with concurrent
treatment with chemotherapy. HSPP C-96 evokes a specific and innate immune response in patients with
recurrent glioma and survival data available to date indicates HSPP C-96 vaccine provides a possible clinical
benefit with a favorable safety profile.