Pipeline & Clinical Data

Overview of Clinical Studies

Cytovac has tested the ALECSAT therapy in a number of clinical trials.

The clinical development program comprises trials in prostate, pancreatic and glioblastoma multiforme (GBM) brain cancer. Across the completed clinical trials, ALECSAT was generally found to be well tolerated and no serious side effects were seen that could be associated to ALECSAT treatment. In addition, several examples of an anti-tumour effect have been seen.

Currently, the main focus of the company is targeted at brain cancer, as the trials in GBM have demonstrated several distinct examples of reduced tumor sizes and indications of longer life expectancies in some patients. Furthermore, Cytovac has been granted Orphan drug designation by both EMA and FDA for treatment of GBM.

For technical and strategic reasons, Cytovac decided to discontinue the first phase II brain cancer study in 2015 and commence a new and re-designed trial. Included in this decision was an advice from the European Medicines Agency (EMA), in which a different trial design was recommended when aiming at obtaining regulatory drug approval in Europe. Moreover, in the first phase II study in relapsed GBM, disease progression had been observed for many of the patients before the therapeutic action of the ALECSAT treatment could take effect.

In the now ongoing redesigned phase II trial, the patients receive treatment very early in the course of their disease – shortly after their diagnosis.

In future clinical trials, the therapeutic effect of ALECSAT treatment will be tested in other types of cancer.

An overview of performed and planned clinical studies:

 

Disease indication Title Status
CV-001

Phase Ia,
“First dose in man”
(single dose)

Prostate cancer A prospective, open-label, single arm, phase I trial to investigate the safety and tolerability of administering ALECSAT to patients with late stage castration-resistant prostate cancer – a First Dose in Man Study. Completed
CV-002

Phase Ib
(several doses)

Prostate cancer

Late-stage

A prospective, open-label, single arm, single center, phase I trial to investigate the safety, tolerability and efficacy of repeated administrations of ALECSAT to patients with late stage castration-resistant prostate cancer. Completed
CV-003

Phase Ib

Glioblastoma multiforme brain (GMB) cancer

Late-stage

A prospective open-label, single arm, single center, phase I trial to investigate safety, tolerability and efficacy of repeated administrations of ALECSAT to patients with late stage relapsed GBM; recurrence after both first- and second-line treatments Completed
CV-004

Phase Ib

Pancreatic-cancer

Late-stage

A prospective, open-label, two-arm, single center, phase I study to investigate the safety, tolerability and efficacy of repeated administerations of ALECSAT to patients with late stage pancreas cancer; had terminated standard of care treatment due to unacceptable side effects or disease progression,or had declined standard of care. Completed
CV-005

Phase II

Glioblastoma multiforme brain (GMB) cancer

Late-stage

A prospective open-label, randomised, two-arm, multi-center phase II trial to investigate the efficacy and safety of repeated administrations of ALECSAT in patients with GMB measured as progression free survival compared to bevacizumab/Irinotecan. Discontinued
CV-006

Phase II

Glioblastoma multiforme (GBM) brain cancer

Newly diagnosed

A prospective, open-label, randomized, two-arm, multiple center, phase II trial to investigate the efficacy and safety of repeated administrations of ALECSAT treatment as an add on therapy to radiotherapy and temozolomide in patients with newly diagnosed GBM. Initiated in January 2016
CV-007

Phase II

Breast Cancer

Triple Negative

  Planned and to be initiated in 2019
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