Links to U.S. National Institutes
of Health Clinical Trials
Clinical MVax® Phase III Clinical Trial
MVax® Phase I/II Clinical Trial
OVax® Phase I/II Clinical Trial
A clinical trial is a research study to answer specific questions about new drugs or treatments for disease. Clinical trials are used to determine whether new treatments are both safe and effective in humans. These trials generally occur after extensive work in the laboratory and in animal studies. Regulated by the Food and Drug Administration (FDA) and other regulatory agencies around the world, carefully conducted clinical trials are an established way to find treatments that are safe and effective.
Our previous clinical trials for the AC Vaccine have concentrated on melanoma, ovarian carcinoma, which are our primary indications, and non-small cell lung cancer.
AC Vaccine® Technology Platform
AVAX utilizes its Autologous Cell (AC) Therapeutic Vaccine platform for the development of products to be used to treat patients with cancer. The idea behind the AC Vaccine technology is to re-educate the patient's immune system to recognize as foreign the cancer cells that are metastasizing and growing in the patient's body outside of the regulation by the patient's immune system. AVAX's lead product is MVax®, the AC Vaccine technology for the treatment of patients with melanoma. AVAX feels that its technology platform has broad applicability to multiple cancers.
Through extensive clinical development AVAX has determined the optimal regimen for administering the AC Vaccine.
MVax® for the Treatment of Melanoma
AVAX's Phase III Study
AVAX plans to launch an International Phase III Registration trial with its lead product MVax® by the end of the year. The Phase III study will enroll approximately 400 patients. AVAX has met with the United States Food and Drug Administration ("FDA") on the study design and has plans to continue to work with FDA to be able to focus and re-launch this pivotal clinical study.
The protocol will be based on published data showing that administration of MVax® alone can induce clinically meaningful anti-tumor responses in patients with stage III and IV melanoma.
OVax® for the Treatment of Ovarian Cancer
Phase I/II Study
In 2014 Avax presented interim results of the ongoing Phase I/II study of the treatment of patients with Stage III & IV ovarian cancer at the Society of Gynecologic Oncology 19th Annual Winter meeting. The study, entitled Trial of Autologous, Hapten-Modified vaccine, OVAX, in patients with Relapsed Stage III or IV Ovarian Cancer, is being conducted by Cancer Treatment Centers of America at its five hospitals.
The study was designed to evaluate three doses of OVax® with dose defined by the number of cells injected in each vaccine; the doses tested were: 5x106 cells (high dose), 2.5x106 cells (medium dose), and 0.5x106 cells (low dose). All dosages were administered according to a previously developed optimum schedule, which included an induction dose without adjuvant followed by low dose cyclophosphamide and then 6 doses admixed with the immunological adjuvant, BCG, Endpoints of the study were safety and an immunological endpoint of delayed-type hypersensitivity (DTH), which is a T-cell-mediated immune response to autologous ovarian cancer cells.
Median overall survival by Kaplan Meier method in the vaccine treated group (n=24) was 25.4 months versus 6.5 months (n=23) in a non-randomized control group of patients that presented for the study but did not receive the treatment. Delayed Type Hypersensitivity, a T cell mediated immune response, to hapten-modified tumor cells was seen in 61% of the patients tested. In 6 vaccinated subjects, CA-125 levels became normal throughout the 9 month duration of the protocol.
The safety profile of OVax® appeared to be very favorable. There were no Serious Adverse Events attributed to OVax®. Non-serious adverse events were similar to what has been observed in previous trials of all of the autologous, haptenized vaccines tested by Avax: mild-moderate injection site reactions in all patients, mild nausea from cyclophosphamide in some patients, and mild constitutional symptoms, such as fatigue, in some patients after vaccine administration.
This is the first ever study conducted with the AC Vaccine in the treatment of Non Small Cell Lung Cancer. The study is treating patients with Stage I, II & III disease that undergo complete surgical resection. The vaccine is given to the patients prior to any other post surgical intervention (chemotherapy, etc.).
The study is designed to evaluate three doses of LungVax® with dose defined by the number of cells injected in each vaccine; the doses tested are: 5x106 cells (high dose), 2.5x106 cells (medium dose), and 0.5x106 cells (low dose). All dosages are administered according to a previously developed optimum schedule, which includes an induction dose without adjuvant followed by low dose cyclophosphamide and then 6 doses admixed with the immunological adjuvant, BCG, Endpoints of the study are safety and an immunological endpoint of delayed-type hypersensitivity (DTH), which is a T-cell-mediated immune response to autologous lung cancer cells.
Planned Future Studies
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