Clinical data

Overview

Cytovac’s clinical development program has focused on three different cancer types: prostate cancer, glioblastoma brain cancer and pancreatic cancer. The studies have shown extremely promising results in the treatment of about 100 patients in total, none of whom experienced adverse effects associated to the treatments that were not easily treated.

The two clinical phase I studies on prostate cancer show indications that the disease is stabilized by slowing down or stopping the increase in PSA (prostate specific antigen) levels in the blood. Further, a reduction in size and number of bone metastases was observed in more than half the patients. And this in spite of these patients being at a late stage in their disease progression.

In the treatment of glioblastoma brain cancer, the clinical phase I and II studies show that, in some patients, the disease is stabilized, and considerable reductions in tumor sizes can also be observed, after the patients have been subjected to the ALECSAT therapy; and, there are also indications that the therapies may be life-prolonging.

The clinical phase I study on ALECSAT for treatment of patients suffering from pancreatic cancer showed that ALECSAT can also be used for this type of cancer – without adverse effects. Clinical phase II studies must be performed to establish the clinical effect of ALECSAT for these patients. This is planned to be conducted in a partnership structure.

An overview of performed and planned clinical studies:

 

Disease indication Title Status
CV-001

Clinical phase Ia,
“First dose in man”
(single dose)

Prostate cancer

Late-stage CRPC.

A prospective, open phase I study to investigate the tolerability and efficacy of administering ALECSAT to prostate cancer patients – a First Dose in Man Study. Completed
CV-002

Clinical phase Ib
(several doses)

Prostate cancer

Late-stage CRPC.

A prospective, open phase I study to investigate the tolerability and efficacy of repeated administrations of ALECSAT to prostate cancer patients. Completed
CV-003

Clinical phase Ib

Glioblastoma brain cancer

Late-stage patients with recurrence after both first- and second-line treatments

A phase I study to investigate tolerability and efficacy of (ALECSAT) to patients with relapsed glioblastoma multiforme (GBM) Completed
CV-004

Clinical phase Ib

Pancreatic-cancer

Late-stage patients after first-line treatments.

A prospective, open phase I study to investigate the tolerability and efficacy of administering ALECSAT to Pancreas cancer patients Completed
CV-005

Clinical phase II
Randomised and controlled

Glioblastoma brain cancer

Late-stage patients with recurrence after first-line treatments.

An Open-labelled, Randomized Phase II Multi center Study to Investigate Efficacy of ALECSAT in Patients with Glioblastoma Multiforme Measured as Progression Free Survival Compared to Avastin/Irinotecan. Discontinued
CV-006

Clinical phase IIa/b
Randomised and controlled

Glioblastoma brain cancer

Newly diagnosed

An open label Phase II study to investigate the efficacy and safety of ALECSAT treatment as an add on therapy to radiotherapy and temozolomide in patients with newly diagnosed glioblastoma. Initiated in January 2016
CV-007

Clinical phase I

Malignant Melanoma skin-cancer patients.   To be planned and initiated in 2017