- What phase II clinical trials are recruiting patients?
- What phase clinical trials are still recruiting patients?
- Who can participate in the Phase II CALM trial?
- How long does the CALM trial last?
- Where are the study sites for the CALM study?
- How is CAVATAK™ administered?
- What is a virus?
- What is a Coxsackie virus?
- How do viruses behave?
- Do you get a common cold when treated with CAVATAK™?
- Why is CAVATAK™ not commercially available yet?
- Why are your patient trial populations relatively small?
- When will CAVATAK™ be available to people with cancer?
- How does CAVATAK™ infect tumour cells?
- Why doesn't CAVATAK™ infect normal cells?
- What cancers might CAVATAK™ treat?
Q. What phase II clinical trials are recruiting patients?
The CALM trial is a Phase II trial designed to test the effectiveness of CAVATAK™ in the treatment of patients with late stage melanoma. This trial has been approved to run in the US by the FDA and patient recruitment has now started in the US.
Contact: clinicaltrials@Viralytics.com for further information regarding the phase II CALM trial.
Q. What phase clinical trials are still recruiting patients?
One phase II clinical trial is currently recruiting patients for clinical trials in the US and one phase I clinical trial is currently recruiting patients for clinical trials in Australia. These are:
Phase II Late Stage Melanoma
Phase I Melanoma, Breast and Prostate Trial
Contact: clinicaltrials@Viralytics.com for further information regarding the Phase II Late Stage Melanoma and the Phase I for Melanoma, Breast and Prostate cancer trials.
Q. Who can participate in the Phase II CALM trial?
Patients with stage IIIc or stage IV melanoma who are 18 years of age or older may be eligible for participation in the trial if they do not have antibodies against CVA21.
Q. How long does the CALM trial last?
Patient Recruitment is expected to be completed in 2014. From entering the CALM trial, patients will be monitored for 6 months, then if responding to treatment the patient will be eligible for a additional 6 month extension study.
Q. Where are the study sites for the CALM study?
Patients are being recruited to study sites in the USA. Country selection outside of the USA for this trial is yet to be decided. Please contact Viralytics (clinicaltrials@Viralytics.com) or your oncologist to gain further information regarding enrolment on one of our clinical trials.
Q. How is CAVATAK™ administered?
In the CALM trial a melanoma nodule will be injected with CAVATAK™ several times over an 18 week treatment period.
Q. What is a virus?
A virus is a submicroscopic organism that can multiply only inside living host cells. It has a non-cellular structure lacking any intrinsic metabolism and usually comprising DNA or RNA molecules inside a protein coat. While the better known viruses are pathogenic (meaning they cause disease) many are not.
Q. What is a Coxsackie virus?
Coxsackie virus is a member of the Picornaviridae family of viruses in the genus termed Enterovirus. Coxsackie viruses are subtype members of Enterovirus that have a single strand of ribonucleic acid (RNA) for its genetic material. The Enteroviruses are also referred to as picornaviruses (pico means "small," so, "small RNA viruses"). Coxsackie virus was first isolated from human feces in the town of Coxsackie, New York, in 1948 by G. Dalldorf.
Q. How do viruses behave?
Viruses need to infect living cells to multiply. They typically invade a cell, then take over the cell’s manufacturing capabilities so that they may replicate. Replicated viral particles then invade surrounding cells.
Q. Do you get a common cold when treated with CAVATAK™?
Generally patients who have CAVATAK™ do not get a common cold as the therapeutic is administered directly into the tumour or into the blood stream, and not through the respiratory tract (ie it is not inhaled).
There is a possibility that some subjects may react to the presence of the coxsackievirus A21 by experiencing flu-like symptoms such as fever, nausea, nasal congestion, headache and aching muscles for a few days only.
Q. Why is CAVATAK™ not commercially available yet?
CAVATAK™ is an investigational drug and is currently being tested in clinical trials. If CAVATAK™ is shown in trials to have significant advantages over current therapies, Viralytics will seek regulatory approval for commercial release.
Q. Why are your patient trial populations relatively small?
Our completed and current Phase I and Phase II clinical trials are run under highly regulated guidelines using only the required number of patients to determine safety and/or efficacy of the new drug.
Q. When will CAVATAK™ be available to people with cancer?
Apart from patients enrolling in our clinical trials, CAVATAK™ will not be available until Phase II and Phase III trials are completed and regulatory approval is achieved.
Q. How does CAVATAK™ infect tumour cells?
Most types of cancer cells have a receptor on their cell surface called ICAM-1. CAVATAK™ latches onto this receptor to gain entry into the cell. Once inside the cell, the virus is able to replicate and produce many more CAVATAK™ virus particles, eventually leading to the death and rupture of the cell. This releases the newly formed virus particles to go on and infect more ICAM-1 bearing cancer cells.
Q. Why doesn't CAVATAK™ infect normal cells?
Normal cells have few if any ICAM-1 receptors so the CAVATAK™ virus does not attach or enter the cell.
Q. What cancers might CAVATAK™ treat?
Clinical trials are underway or planned to assess CAVATAK™ therapy in melanoma, breast, prostate and head & neck cancers.
CAVATAK™ and EVATAK™ are being tested in pre-clinical studies for use in pancreatic cancer, glioma, lung cancer, ovarian cancer and prostate cancer as they target a receptor which is only present on cancer cells and not normal cells.