BioVex initiates Phase 1 Clinical Trial with its genital herpes vaccine, ImmunoVEXHSV2
Woburn, MA, 4 March 2010 - BioVex Inc, a private biotechnology company developing new generation biologics for the treatment of cancer and prevention of infectious disease, announced today that the first subject had been dosed in the Phase 1 study of its live attenuated genital herpes vaccine, ImmunoVEXHSV2. The Phase 1 study is an open label ascending dose trial, assessing safety and immune response in healthy volunteers. The study is taking place in the UK at the Chelsea and Westminster Hospital in London and will involve up to 42 already identified subjects. The principle investigator is Dr Simon Barton.
"Developing an effective vaccine against genital herpes has historically proved challenging. ImmunoVEX is a rationally designed live attenuated vaccine specifically constructed to address the limitations of previous vaccines. We believe our vaccine is built on sound science, providing a solid basis upon which to anticipate success in the clinic. We look forward to evaluating the Phase 1 data in late 2010 and based on positive outcomes, moving ImmunoVEX into later stage efficacy trials soon thereafter," said Dr Robert Coffin, Founder & CTO for BioVex.
"Genital herpes is an endemic disease which causes untold physical and emotional suffering. Treatments for those with frequent recurrences are inadequate, and no prophylactic vaccine candidate so far tested has proved sufficiently effective for widespread use. The causative agent of genital herpes, herpes simplex virus 2, is therefore a very important target for vaccine development, both from a preventive and therapeutic perspective," said Dr Simon Barton of the Chelsea and Westminster Hospital, London.
Marian Nicholson, Director of the Herpes Viruses Association commented "We have been keeping an eye on the progress of ImmunoVEXHSV2 for a while and are looking forward to knowing if this vaccine shows promise in the clinic as a protection for people who have not caught the virus and potentially as a therapy for people with frequent outbreaks of herpes simplex type 2," She added that "the trial is already fully enrolled but to follow updates people can check the 'What's New' page on our website: www.herpes.org.uk, and for more general information on herpes simplex, check the other pages or phone our helpline on +44 845 123 2305."
ImmunoVEXHSV2 is based on a proprietary engineered form of the causative agent of genital herpes, HSV-2, from which genes that collectively interfere with the functions of immune system have been deleted. The proteins encoded by these genes aid wild type HSV-2 in evading the body's immune system.
ImmunoVEXHSV2 expresses all but four of the approximately 80 HSV-2 proteins, maximizing the breadth of the anti-HSV immune response generated, but without the genes encoding for these immune-inhibiting proteins.
ImmunoVEXHSV2 has been evaluated in the industry-standard preclinical model of genital herpes, in which it completely prevented disease, suggesting that ImmunoVEXHSV2 may be more potent in humans than other HSV-2 vaccines for which published data is available. The vaccine also considerably reduced the level of viral shedding following exposure, which if this translates to the clinical setting, may also reduce any window of infectivity from an infected individual.
About Genital Herpes
At least 45 million people over the age of 11 in the United States have been infected with HSV-2, the causative agent of genital herpes, the rate of infection having increased approximately 30% between the late 1970s and the early 1990s, according to the Centers for Disease Control and Prevention. In addition to classical genital lesions, patients with compromised immune systems may experience more severe, systemic complications, including in some cases cystitis, urethritis, cervicitis and meningitis. According to research reported in Biomed Central's journal BMC Infectious Diseases, the economic burden of genital HSV infection and resulting complications has been estimated to be greater than $1 billion annually in the United States alone.
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.
The Company's lead product, OncoVEXGM-CSF is a first in class oncolytic vaccine. OncoVEXGM-CSF replicates selectively in tumors; destroying cancer cells whist leaving surrounding healthy cells unharmed. OncoVEXGM-CSF is also intended to induce a powerful immune response to kill cancer cells throughout the body. Both local and distant 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 OncoVEXGM-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 recently commenced 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 OncoVEXGM-CSF as a stand alone therapy in patients with advanced disease (see Journal of Clinical Oncology, Vol 27, 2009: pp. 5763-5771).
An overview of these results is also available on the BioVex website. In September 2009 the Company received approval from the FDA for a second Phase 3 study, in head and neck cancer, also under the SPA procedure.
BioVex recently closed a $70m funding round representing the second largest venture capital raise in the biotech sector in 2009.
For further information, please go to www.biovex.com.
About The Chelsea and Westminster Hospital
Chelsea and Westminster Hospital NHS Foundation Trust in West London is one of the leading hospitals in England, ranked among the top 9% of NHS trusts nationally in the Care Quality Commission's annual performance ratings 2009. It provides not only a wide range of general hospital services for people living locally but also a number of specialist services for patients from further afield. Chelsea and Westminster has a national, and indeed international reputation, for the excellence of its sexual health and HIV services - it is a centre of not only clinical services but also research. More information is available at www.chelwest.nhs.uk/hiv-sexual-health/index.html.
About the Herpes Viruses Association
The HVA is a patient support organisation, run for and by people who have been diagnosed with herpes simplex. Most people with herpes simplex are unaware that they have it and remain undiagnosed. Some people diagnosed with genital herpes may get frequent or severe symptoms. Inquiries about the patient perspective of genital herpes and the background to the stigma associated with the condition should be directed to the HVA - see contact details below.
The HVA offers:
- A helpline (0845 123 2305, calls charged at local rate) run by trained volunteers
- A website ( www.herpes.org.uk )
- Booklets and other materials for distribution through sexual health clinics
- Leaflets and quarterly journals for subscribers, dealing with all aspects of the virus
- Talks and study days.
- Advice on treatment: self-help and prescribed medication.
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Tel: +1 608-850-4745
The Herpes Viruses Association
Tel: +44 20 7607 9661