BioVex to Report Phase I/II Clinical Trial Results for the Front Line Treatment of Head and Neck Cancer With OncoVEX GM-CSF at the 2009 American Society of Clinical Oncology Meeting
WOBURN, Mass., May 15 /PRNewswire/ -- BioVex Inc, a company developing new generation biologics for the treatment and prevention of cancer and infectious disease, announced today that updated survival data from its Phase II study in metastatic melanoma will be presented at the 2009 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from May 29, 2009 - June 2, 2009 in Orlando, FL.
Senior clinical investigator, Neil N. Senzer, M.D., will present the data in an abstract (number 9035) entitled "Phase II clinical trial with a second generation, GM-CSF encoding, oncolytic herpes virus in unresectable metastatic melanoma," at ASCO on Monday, June 1, 2009 from 8:00am - 12:00pm EDT during the melanoma poster session located in Level 2, West Hall C.
The Phase II trial enrolled 50 patients with Stage IIIc (10 patients) and Stage IV melanoma (40 patients) who were treated with OncoVEX GM-CSF as a stand-alone therapy. The trial was designed to measure overall objective response, which is defined as a complete response (CR), where disease is completely eliminated, or partial response (PR), where there is a >30% reduction in disease burden. The vast majority of patients who entered the study had progressive disease after having failed conventional and experimental prior therapies. 13 objective systemic responses (26% objective response rate) were achieved including nine CRs, eight of which remain alive and free of disease. 12 responses have so far continued for more than 6 months (range 6-29+ months). Responses were observed in patients with all stages of disease, including the complete resolution of un-injected visceral deposits.
The abstract for the presentation reports that, at the time of submission, overall median survival (by Kaplan-Meier estimation) exceeded 16 months for all patients as well as for those patients with only Stage IV disease. Estimated one year survival was 61% for all patients, 58% for all Stage IV patients and 48% for Stage IV M1c patients. The 1-year survival of the patients who achieved PR, CR or surgical CR (n=15) was 93% compared to 48% for those with stable or progressive disease.
Commenting on these results, Dr. Neil N. Senzer of The Mary Crowley Cancer Research Center in Dallas, TX, the lead author for the presentation, said:
"Compared to any historical benchmarks for patients with Stage IIIc and Stage IV melanoma, this survival data, especially when coupled with a low toxicity profile, is provocative. Additionally, of the responses previously reported the vast majority have been maintained for up to more than three years from enrollment. I look forward to the results of the subsequent Phase III study which has recently initiated."
OPTiM Phase III Trial
The trial is a multi-national, open label, randomized Phase 3 study to assess the efficacy and safety of treatment with OncoVEX GM-CSF as compared to sub cutaneously administered GM-CSF in patients with unresectable stage III (b-c) and Stage IV (M1a-c) disease. The primary endpoint is the rate of durable (maintained for six months) objective response. Patients will have received at least one prior therapy for active disease which includes any type of therapy including investigational drugs. A total of 360 patients will be enrolled (240 to the OncoVEX GM-CSF arm and 120 to the control arm). The study design was agreed with the FDA under the Special Protocol Assessment ("SPA") process. The SPA process provides for a designation from the FDA that the trial's design, clinical endpoints and statistical analysis can be used for regulatory approval.
About Metastatic Melanoma
According to the American Cancer Society, more than 8,000 people died in the U.S. of melanoma in 2007. Prevalence of stage III and stage IV disease is 120,000 and median survival for Stage IV disease is six months.
Treatment of melanoma depends on the stage of the disease with surgical resection being effective in less severe non metastatic forms of the disease. However, survival rates for later Stage III and IV patients are poor, reflecting the lack of any efficacious drugs for metastatic disease. Current systemic therapies are not generally effective in terms of generating durable responses or in impacting survival. As a result, many patients presenting with metastatic disease are directly enrolled into a clinical trial. The vast majority of experimental therapies have failed to show more than a single digit durable response rate.
BioVex is a privately held biotechnology company based in Woburn, MA 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.
The Company's lead cancer technology platform, OncoVEX GM-CSF is a first-in-class oncolytic, or cancer destroying virus technology. OncoVEX GM-CSF works by; replicating and spreading within solid tumors (whilst leaving healthy tissue unharmed), causing the death of cancer cells; and through stimulating the immune system to destroy un-injected metastatic deposits. Both modes of action have been clearly validated in the clinic, where multiple patients with metastatic disease progressing at enrollment have been declared disease free. 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 generated to date, coupled with a benign side effect profile. Previous clinical trials have enrolled patients with breast cancer, head and neck cancer, and pancreatic cancer in addition to melanoma, and clinical activity has been observed in each of these cancer types. The Company plans to submit a second Phase 3 protocol in head and neck cancer to the FDA under the SPA procedure in the middle of the year.
The Company's second program is a vaccine for genital herpes, ImmunoVEX HSV2, which provides complete protection in animal models of the disease. The vaccine has been authorized to commence clinical testing in the UK.
For further information, please go to www.biovex.com.
Source: BioVex Inc
Web Site: http://www.biovex.com/
Posted: May 2009