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BIOVALID SIGNED

Clinical validation of the DiviTum assay in two high profile clinical studies in Europe

Total Cost €

EC-Contrib. €

Partnership

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Outcomes and
results

BIOVALID project word cloud

Explore the words cloud of the BIOVALID project. It provides you a very rough idea of what is the project "BIOVALID" about.

trade cancer trial pharma cyclin previously sme solid drug profile decreased shorter serum gold time comprised critical cdk lacking ineffective clinicians developers institutes rationale feasibility commercialization tools oncology validated receiving cycle predictive pool administer decision proliferation saving assay biomarker instrument tk divitum scientific treatments paying regulatory monitoring segment inhibitors disrupt benefit detection treat rates optimized negotiated cell tumors optimal standard kit successfully cohort payers efficacy regulating risk clinically kinase dependent tool company inhibitor enzyme compelling clinical drugs responders regulation patients companies market thymidine practiced treatment therapy

Project "BIOVALID" data sheet

The following table provides information about the project.

Coordinator	BIOVICA INTERNATIONAL AB Organization address address: DAG HAMMARSKJOLDS VAG 54B city: UPPSALA postcode: 752 37 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.
Coordinator Country	Sweden [SE]
Project website	http://www.biovica.com
Total cost	682˙506 €
EC max contribution	682˙506 € (100%)
Programme	1. H2020-EU.3.1. (SOCIETAL CHALLENGES - Health, demographic change and well-being) 2. H2020-EU.2.3.1. (Mainstreaming SME support, especially through a dedicated instrument)
Code Call	H2020-SMEINST-2-2015
Funding Scheme	SME-2
Starting year	2015
Duration (year-month-day)	from 2015-09-01 to 2021-11-30

Partnership

Take a look of project's partnership.

#	participants	country	role	EC contrib. [€]
1	BIOVICA INTERNATIONAL AB BIOVICA INTERNATIONAL AB Organization address address: DAG HAMMARSKJOLDS VAG 54B city: UPPSALA postcode: 752 37 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	SE (UPPSALA)	coordinator	682˙506.00

Map

Project objective

The traditionally practiced approach to cancer therapy and development of new cancer drugs is to treat a large pool of patients as potential responders. This results in patients not receiving the optimal treatment; payers paying for treatments that do not benefit patients; drug developers facing higher risk of regulatory failure due to not being able to use better tools for selection of patients in the clinical development program; and clinicians lacking predictive and monitoring tools to administer optimal treatment of patients. Our company has developed a state-of-the-art assay kit - DiviTum™, for the serum-based detection of Thymidine Kinase (TK) activity – a key enzyme involved in cell proliferation. There is compelling scientific rationale to use TK as a biomarker for drugs that disrupt cell cycle regulation, such as Cyclin Dependent Kinase (CDK) inhibitors. As part of the previously conducted SME Instrument Phase 1 feasibility study, our company has identified the clinical study & research market segment, comprised of pharma companies that develop CDK inhibitors, as a current target for the commercialization of DiviTum™. Our company has successfully negotiated to be part of two high-profile clinical studies involving a novel CDK inhibitor with leading oncology institutes in Europe. A clinically validated DiviTum™ has the potential to become the gold standard predictive and efficacy biomarker for cell cycle regulating drugs in selected advanced, solid tumors. This will benefit patients through improved utilization of current and novel treatments; payers by saving costs on ineffective treatments; clinicians by providing a critical clinical decision tool; and drug developers by improving clinical trial success rates through optimized cohort selection, shorter time to market and decreased risk of regulatory failure.

Deliverables

List of deliverables.
White Paper	Documents, reports	2019-05-30 13:19:07

Take a look to the deliverables list in detail: detailed list of BIOVALID deliverables.

Publications

List of publications.
year	authors and title	journal	last update
2016	Shana Thomas1, Ning Liu1, Rosy (Jingqin) Luo1, Jeremy Hoog1, Mattias Bergqvist2, Magnus NeumÃ¼ller2, Edward M. Suh2, Zhanfang Guo1, Kiran Vij1, Souzan Sanati1, Matthew Ellis3, Cynthia X. Ma1 1Washington University School of Medicine, St. Louis, MO, 63110; 2 Biovica International AB, Uppsala, Sweden, 3Baylor College of Medicine, Houston, TX, 77030 Serum Thymidine Kinase 1 Activity as a Pharmacodynamics Marker of Cyclin-Dependent Kinase 4/6Inhibition in Patients with Early Stage Breast Cancer Receiving Neoadjuvant Palbociclib published pages: , ISSN: , DOI:	San Antonio Breast Cancer Symposium, SABCS 2016, Abstract P5-04-02 ANNUAL	2018-03-29

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