AroCell TK 210 ELISA has been developed in response to unmet clinical needs.
To effectively use clinical resources and ensure the highest ethical standards and safety, AroCell is performing clinical investigations, both with partners and independently. Clinical investigations involve literature searches, assessment, and analysis of clinical data pertaining to AroCell TK 210 ELISA, combined on occasion with other medical devices and pharmaceuticals, to verify the safety, performance, and effectiveness of AroCell TK 210 ELISA with regards to a specific unmet clinical need.
AroCell is participating in the following clinical studies:
- U-CAN (predictive and prognostic information in blood malignancies)
- Promix (prognostic information and grading of breast cancer therapy)
- Sarcoma (early detection of recurrence in sarcoma)
- SÖS (prostate cancer)
Several of these have been completed and the work to analyze and publish the results has been accelerated.
Hematological malignancies; U-CAN TK1 study at Uppsala Akademiska Hospital:
In the study AroCell TK 210 ELISA is used for monitoring the effect of rituximab (Rituxan®) + CHOP (cyclophosphamide + doxorubicin + vincristine + predisone) chemotherapy on patients suffering from DLBCL (Diffuse Large B-Cell Lymphoma), an aggressive form of non-Hodgkin’s lymphoma with an incidence of approximately 7 per 100 000 globally (United States National Cancer Institute’s SEER Database).
The study is retrospective and includes serum samples form 190 patients from the UCAN biobank. Serum samples are collected prior to treatment, during treatment and at follow-up or relapse. Endpoints are prognosis for disease overall survival rate, evaluation of the sensitivity and specificity of diagnostic measurements using AroCell TK 210 ELISA to detect response/non-response to rituximab + CHOP treatment, TK 1 levels as efficacy of (treatment efficiency), and early detection of relapse.
The preliminary results suggest that AroCell TK 210 ELISA may be used for monitoring the effect of therapy of DLBCL patients under rituximab + CHOP treatment, and for determination of overall survival rate. Analysis of data is ongoing, and publication of results are pending.
Breast cancer; Promix, at Karolinska hospital in Stockholm
The study is an open multicenter trial evaluating the combined preoperative treatment with epirubicin, docetaxel (Taxotere®) and bevacizumab (Avastin®) of breast cancer. This is a translational trial investigating functional imaging and molecular factors to predict response early during treatment.
Among the aims of the study are:
1) To evaluate the sensitivity and specificity of defined diagnostic and biological procedures to detect response/non-response to neoadjuvant treatment at an early point among patients with breast cancer which are not primarily suitable for surgery.
2) To compare standard evaluation procedures, mammography, conventional ultrasound and clinical response, with functional imaging and biological procedures with regard to early detection of response/progression (please refer to www.clinicaltrial.gov for the entire protocol).
The study is prospective and includes 148 patients.
Primary endpoints are:
1) Early objective vs. response characterized by imaging and biological tumor markers after two cycles of treatment with epirubicin + docetaxel.
2) Effects of addition of bevacizumab in patients with breast cancer which are not primarily suitable for surgery.
3) Early functional and biological changes signaling pathological complete response (pCR).
Secondary endpoints are treatment response by conventional diagnostic procedures, functional imaging, and morphological and biological signals of tumor response.
AroCell TK 210 ELISA is used to measure the concentration of the proliferation and cell disruption biological marker TK1, as one biological modality to monitor response before and during the preoperative treatment, as well as to determine overall survival rate. The collection of samples is completed and analysis and preparation of manuscripts for review and publication is ongoing.
The Sarcoma TK1 study; at Helsinki hospital in Finland
This prospective study includes 60 patients suffering from various forms of soft and hard tissue sarcoma. TK1 concentrations in serum samples from patients collected before, during and after treatment will be measured using AroCell TK 210 ELISA.
The objective of the investigation is to evaluate if Thymidine Kinase has the potential to function as a prognostic biomarker and for the detection of disease recurrence. Serum samples are collected at diagnosis, after primary therapy, in patients with successful anti-cancer therapy, and at one-year follow-up. Samples is also collected in cases of sarcoma recurrence or detection of metastasis. The level of Thymidine Kinase will be analyzed versus disease progression, tumor size and histologic sarcoma grade.
The collection of samples will finish in the end of 2018 or early 2019. Analysis of data is planned for in 2019.
Prostate cancer; The SÖS TK1 study at Stockholm South General Hospital
This prospective study includes up to 300 patients with suspected prostate cancer. Recently the study has been focused on late stage disease and includes metastasized patients under hormone treatment in two groups; either conventional treatment with bicalutamid and GnRH (Gonadotropin Releasing Hormone), or treatment with abiraterone (Zytiga®) or enzalutamide (Xtandi®)
The study aims to evaluate biomarkers for early detection of response to treatment. The primary objective is to validate AroCell TK 210 ELISA in combination with PSA for monitoring of males confirmed with metastasized late stage prostate cancer under hormone treatment. AroCell TK 210 ELISA will be measured at the first visit and then 2-4 times per year during follow-up.
The collection of samples will continue throughout 2019 and AroCell TK 210 ELISA will be used to determine the concentration of TK1. Objective: to validate AroCell TK 210 ELISA in combination with PSA for monitoring of males with confirmed metastasized late stage prostate cancer under hormone treatment. AroCell TK 210 ELISA will be measured at the first visit and then 2-4 times per year during follow up.
Investigator initiated clinical research studies
Today AroCell has several ongoing external collaborations. We are dedicated to supporting meaningful, independent clinical research conducted by qualified investigators. Studies are consistent with our areas of interest and our commitment to improving the care of patients suffering from cancer. AroCell may also provide funding and other forms of support, such as product and testing services.
All physicians, healthcare providers, researchers and institutions worldwide who are interested in conducting their own research are eligible to submit a study proposal. All proposals are reviewed on their merit by a select review committee. Criteria for approval include scientific merit and alignment with the AroCell’s areas of interest.
For clinical research study proposal, please contact Michael Brobjer, Michael.firstname.lastname@example.org
Investigator and/or institution responsibilities include study design, execution and compliance with all institutional and regulatory requirements. Support is subject to resource availability and on the condition of an approved study concept proposal, full study protocol and full execution of a research support agreement by both parties.