BioVex Inc, a company developing new generation biologics for the treatment of cancer and prevention of infectious disease, announces that the data from its completed Phase I/II clinical study of OncoVEXGM-CSF for the first line treatment of head and neck cancer is being published today in Clinical Cancer Research, an ASCO publication.
The previously announced top line results report a high complete pathological response rate and a low relapse rate in combination with cisplatin and radiation, combined with a relatively benign side effect profile. Following from this data, a Phase III study, also in patients with previously untreated squamous cell carcinoma of the head and neck, will begin later this year under an SPA (Special Protocol Assessment) from the FDA, as previously announced.
In the study published today, OncoVEXGM-CSF was injected into 17 patients’ cancer-affected lymph nodes in up to four doses, and the patients were also given radiotherapy and chemotherapy. Head and neck tumour shrinkage could be seen on scans for 14 patients (82.3%), while 93 per cent of patients had no trace of residual cancer in their lymph nodes when subsequently surgically removed. After an average follow-up time of 29 months (19 to 40 months), 82.4 per cent of patients remained alive. Only two of 13 patients given the top virus treatment dose relapsed, and no patient had recurrent loco-regional disease.
Side-effects were generally mild to moderate, and most – except fever and fatigue – were thought to be due to the chemotherapy or radiotherapy. OncoVEXGM-CSF has previously shown promising results when administered on its own in patients with other cancer types, including a Phase II trial in metastatic melanoma patients where a Phase III trial is currently underway.
Around 650,000 people are diagnosed with squamous cell cancer of the head and neck each year worldwide, and around 350,000 die from the disease annually.
Dr Robert Coffin, Founder and Chief Technology Officer, for BioVex, said:
“Up to half of patients given the current standard treatment of chemotherapy combined with radiotherapy typically relapse within two years, following which the prognosis is grim, so these results compare very favorably. This, combined with the very high complete pathological response rate indicates that OncoVEXGM-CSF may provide significant additional clinical benefit to chemotherapy and radiotherapy alone, hence our decision to move directly to a pivotal Phase III trial.
In addition to head and neck cancer, and melanoma where a pivotal Phase III trial is currently underway, we also believe that OncoVEXGM-CSF has significant potential to treat a wide variety of other tumor types either alone or in combination with other therapies, for which the planning of additional clinical trials is underway.”
OncoVEXGM-CSFis a first in class oncolytic vaccine. OncoVEX replicates selectively in tumors; destroying cancer cells whist leaving surrounding healthy cells unharmed. OncoVEX is also intended to induce a powerful immune response that kills cancer cells throughout the body. Both modes of action have been validated in the clinic, where multiple patients with metastatic disease progressing at enrollment have become free of disease. BioVex believes OncoVEX GM-CSF has the potential to become a leading standard of care in the treatment of many solid tumors based on the strength of clinical data so far generated coupled with the relatively benign side effect profile noted to date. Previous clinical trials have enrolled patients with breast cancer, melanoma, head and neck cancer and pancreatic cancer, with indications of clinical activity being observed in each. The Company is currently conducting a Phase 3 study in metastatic melanoma (the OPTiM study) following achieving an unprecedented proportion of durable complete remissions in a Phase 2 study using OncoVEX GM-CSF as a stand alone therapy. A second phase 3 study in Head and Neck cancer will commence in the fourth quarter.
BioVex is a privately held biotechnology company based in Woburn, Mass. where it also has an operational launch grade manufacturing facility. The Company is developing a new class of potent biologics for the treatment of cancer and prevention of infectious disease. In addition to OncoVEX, the Company has a second development program, ImmunoVEXHSV2,a vaccine for genital herpes that provided complete protection in animal models of the disease. The vaccine is currently undergoing clinical testing in the United Kingdom. BioVex closed a $70m funding round late last year representing the second largest venture capital raise in the biotech sector in 2009.