Information for Patients

Crusade Laboratories is involved in a variety of pre-clinical research programmes, and in several clinical trials. At the centre of our research is the selectively replication competent HSV mutant that fails to express the virulence factor ICP34.5., known as HSV1716.

Frequently Asked Questions

Please select a question below to be taken straight to the answer:

• What is Herpes Simplex Virus HSV1716?
• What is a clinical trial?
• What type of cancers have you tested the new treatment, HSV1716, in so far?
• What type of cancers are you treating with this new agent? Are there any ongoing trials?
• Where can I get more information should I have any questions? How do I know if I am suitable for a trial?
• Are there clinical trials available to patients outside the UK?
• Is there any literature published on the previous trials you have done with HSV1716?

What is Herpes Simplex Virus HSV1716?

HSV1716 is a modified version of the herpes simplex virus (HSV) that causes cold sores. The virus has the ability to destroy rapidly dividing cancer cells whilst leaving the surrounding normal cells unharmed.

What is a clinical trial?

A clinical trial is a research study in human volunteers, conducted in strictly controlled settings, evaluating new medical treatments for patients. The aim of such trials is to determine whether a new treatment option is safe, effective and better than currently available treatments. These trials have to be approved by several regulatory authorities and ethics committees before they can commence. Patients also have to give their informed consent to take part in such a study.

There are different types or phases of clinical trials. In phase I trials a small group of either healthy volunteers or patients with the specific disease under evaluation, will receive a new treatment to determine its safety, metabolism and dose ranges. Phase II trials are conducted in a larger group of patients with the disease under study, to assess clinical efficacy of the new treatment. Phase III trials involve a large number of patients to test the clinical effectiveness of the new treatment, normally in comparison to any established treatment available, and to monitor for any side effects. Phase IV studies are post-marketing studies to delineate additional information including the drug's benefits, optimal use and side effects.

What type of cancers have you tested the new treatment, HSV1716, in so far?

We have conducted several trials in patients with a type of brain cancer, called glioma. We have also conducted trials in patients with skin cancer (melanoma), and a head and neck cancer (squamous carcinoma). All of these trials have shown promising results.

What type of cancers are you treating with this new agent? Are there any ongoing trials?

We are hoping to treat several cancers in the future and are currently doing research into the treatment of a variety of cancers.

At present, we are about to start a phase III trial in patients who suffer from a type of brain tumour called glioblastoma multiforme. This is Crusade’s most advanced study. It is planned that over 380 patients in various countries, including the UK, will be able to take part in this study. This trial will assess patients who have had surgery and radiotherapy treatment for their tumour, but have recurrence of the tumour. This is a randomized study where patients are either allocated to receiving conventional chemotherapy treatment or, administration of HSV1716 into their tumour.

Where can I get more information should I have any questions? How do I know if I am suitable for a trial?

Please e-mail us on info@crusadelabs.co.uk should you require any more information or contact us on 08700 1716 00. If appropriate, we can advise you to see your doctor, who can then refer you to a hospital participating in the clinical trial.

Are there clinical trials available to patients outside the UK.

It is planned, that the phase III trial in patients with the brain tumour glioblastoma multiforme, will also be available in several European Countries.

Is there any literature published on the previous trials you have done with HSV1716?

There are medical and scientific articles available on these previous trials. Below is a list of some of those articles:

Rampling R, Cruickshank G, Papanastassiou V, et al. Toxicity evaluation of replication-competent herpes simplex virus (ICP 34.5 null mutant 1716) in patients with recurrent malignant glioma. Gene Ther 2000;7(10):859-66.

Papanastassiou V, Rampling R, Fraser M, et al. The potential for efficacy of the modified (ICP 34.5(-)) herpes simplex virus HSV1716 following intratumoural injection into human malignant glioma: a proof of principle study. Gene Ther 2002;9(6):398-406.

MacKie RM, Stewart B, Brown SM. Intralesional injection of herpes simplex virus 1716 in metastatic melanoma. Lancet 2001;357(9255):525-6.

Harrow, S., Papanastassiou, V., Harland, J., Mabbs, R., Petty, R., Fraser, M., Hadley, D., Patterson, J., Brown, S. M., Rampling, R. HSV1716 injection into the brain adjacent to tumour following surgical resection of high-grade glioma: safety data and long-term survival. Gene Ther 2004;11(22):1648-58