Favorable Safety Profile of Genticel's Technology observed at 18 Months in DSMB Review of Phase 2 Trial with GTL001
Genticel (Euronext Paris & Brussels: FR00011790542 – GTCL), a clinical-stage biotechnology company and developer of innovative immunotherapies to prevent cancers caused by the human papillomavirus (HPV), today announced that it has engaged Eumedix, a leading European corporate finance specialist, as strategic advisor.
In accordance with the direction announced last January, Eumedix will support Genticel in evaluating its strategic options, with a particular focus on facilitating the Company's access to innovative drug candidates. Genticel will be carrying out this process in parallel with the assessment of its current HPV program.
The Company also announced that the independent Data Safety and Monitoring Board (DSMB) found no safety concerns in the ongoing phase 2 trial with GTL001, which is an important result for its partnership with Serum Institute of India Ltd in other vaccine applications.
Benedikt Timmerman, PhD, Chief Executive Officer of Genticel concluded: “Eumedix assisted Genticel during our IPO in 2014 and we are very pleased to rely again on its expertise in the final stages of acquiring advanced drug development assets with the potential to drive new growth in Genticel.”
Founded by Alain Lostis in 2000, Eumedix is a leading European advisory firm in corporate finance for fast companies. By adding strategic insight to complex transactions, Eumedix advises entrepreneurs on key transactions such as: Capital Raising from Private Equity funds; Public Markets offering in partnership with bank syndicate (IPO, follow-on offerings) and Mergers & Acquisition.
Eumedix has a unique trackrecord in the lifescience sector with more than 40 transactions advised, including advising on critical acceleration phases of top companies such as CoreValve, DBV Technologies, Adocia, ...
More information at www.eumedix.com
Aiming to solve a public health issue.
Among the 300 million women around the world currently infected with HPV, 500,000 new cases of cervical cancer are identified each year and 275,000 women succumb to the disease. 70% of cervical cancer cases are caused by 2 HPV types and Genticel aims to eliminate them at an early stage with GTL001, its first-in-class immunotherapeutic candidate. GTL001 clinical efficacy is being evaluated in a 24-month proof of concept Phase 2 trial in Europe.
Offering a promising technological platform.
Genticel's versatile platform, Vaxiclase, is well suited for the development of immunotherapies against multiple infectious or cancerous diseases. A partnership on the use of Vaxiclase has already been established with Serum Institute of India Ltd (SILL), the largest producer of vaccine dose worldwide. This agreement covers territories outside of the USA and Europe, and could generate up to $57 million in revenues for Genticel, before royalties on sales, It will enable SIIL to develop acellular multivalent combination vaccines against a variety of infectious diseases, including whooping cough.
More information at www.genticel.com
Forward Looking Statement
This press release contains forward-looking statements that are not promises or guarantees and involve substantial risks and uncertainties. The Company's product candidates have not been approved for sale in any jurisdiction. Among the factors that could cause actual results to differ materially from those described or projected herein are uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals, the risk that historical preclinical results may not be predictive of future clinical trial results, and the risk that historical clinical trial results may not be predictive of future trial results. A further list and description of these risks, uncertainties and other risks can be found in the Company's regulatory filings with the French “Autorité des Marchés Financiers”, including in the Company's Annual Report for the year ended December 31, 2015 and future filings and reports by the Company which are available on the Company's website.. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Genticel undertakes no obligation to update or revise the information contained in this Press Release, whether as a result of new information, future events or circumstances or otherwise.
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