BARCELONA, Spain, November 22, 2016 /PRNewswire/ --
ABTL0812 is administered in combination with carboplatin and paclitaxel
Vall d'Hebron Institute of Oncology (VHIO, Barcelona) and Catalan Institute of Oncology (ICO, Barcelona) lead the study, which includes other centers in Spain and France
The biopharmaceutical company AbilityPharma announced the initiation of the first Phase 2 Trial with its targeted drug candidate ABTL0812 as first-line therapy to evaluate its efficacy and safety combined with paclitaxel and carboplatin in 80 patients with advanced or recurrent endometrial cancer or squamous lung cancer. The study is initially being conducted in Barcelona at Vall d'Hebron Institute of Oncology (VHIO) and Institut Català d'Oncologia (ICO) by Dr. Ana Oaknin and Dr. Ernest Nadal as principal investigators for endometrial cancer and lung cancer respectively. Dr. Jordi Rodon (VHIO) is the coordinating investigator. Additional sites in France and Spain will be added over the next 6 months.
"ABTL0812 has shown to be extremely safe in patients during the Phase 1b with initial efficacy and high activity on biomarkers", said Dr. Carles Domènech, Chief Executive Officer and co-founder of AbilityPharma. "Additionally, the high efficacy observed in combination in preclinical models make us expect good results in the Phase 2".
ABTL0812 causes cell death by autophagy through the overexpression of TRIB3, an endogenous Akt regulator. It is a first in class fully differentiated oral targeted anticancer compound inhibiting the PI3K/Akt/mTOR pathway without being a direct kinase inhibitor. Its unique mechanism of action was published at Clinical Cancer Research in 2015.
In the phase 1/1b clinical trial (29 patients), ABTL0812 showed the best safety and tolerability compared to other inhibitors of the pathway; without dose-limiting toxicities. The efficacy was comparable to the best PI3K/Akt/mTOR inhibitors; remarkably 2 patients had extremely long disease stabilizations (14 and 18 months).
About Ability Pharmaceuticals
AbilityPharma (http://www.abilitypharma.com), a fast grower in the Catalan and Spanish biopharmaceutical sector, is focusing on creating the future of oncology by developing innovative therapies to address unmet medical needs. Current shareholders include its founders, private investor and the VCs Inveready and SODENA, and has financial support from ACCIO, CDTI, ENISA and MINECO
In April 2016, AbilityPharma signed a territorial license agreement with SciClone Pharmaceuticals, Inc to develop and market ABTL0812 in Greater China