Ability Pharmaceuticals, a Catalan privately held biopharmaceutical company, has announced the approval from the Spanish Medicines Agency (AEMPS) to initiate a Phase I/Ib clinical trial of the novel anticancer drug ABTL0812 in patients with advanced cancer. This is a first-in-humans study that will be conducted at Hospital Clínic Barcelona.
 
ABTL0812 is a new anticancer drug that inhibits the proliferation of cancer cells through the inhibition of the mTORC1/C2 pathway with a novel mechanism of action. It has shown excellent efficacy in preclinical studies with extremely high safety.  ABTL0812 will be administered to patient orally once daily.
 
“We are a young company and we are very satisfied to have been able to get the approval from the Spanish Medicines Agency to start the first clinical trial with our first drug candidate ABTL0812 in just 3 years”– highlights Dr. Carles Domènech, Chief Executive Officer of the company-. “ABTL0812 is very convenient for patients, it is an oral solution, given once daily; and most importantly it has high efficacy with an excellent safety window.”
 
The drug is aimed to the treatment of patients with advanced cancer such as lung or pancreatic, for whom the options of treatment are limited. The primary objectives of the trial with ABTL0812 will be to establish the safety profile and the appropriate dose for future phase II clinical trials. The secondary objective of the trial is the evaluation of ABTL0812’s efficacy, including also novel non-invasive biomarkers.
 
About ABTL0812
 
ABTL0812 simultaneously and selectively targets key targets related to cellular proliferation of tumor cells. As a result of this action ABTL0812 inhibits mTORC1 and mTORC2 pathways and impairs the synthesis of a key enzyme needed for DNA synthesis, dihydrofolate reductase. With this novel approach, proliferation of tumor cells is inhibited causing cell death by autophagy, and at the same time, reducing the probability of the appearance of mutations that lead to resistance to drug  treatments. The preclinical profile of ABTL0812 has revealed excellent efficacy both in xenografts and in cancer cells that have become resistant or are refractory to different anticancer therapies. In addition, the safety profile of ABTL0812 is among the highest in comparison to other targeted anticancer therapies.
 
 
About NSCLC and Pancreatic cancer
 
Lung cancer is one of the most serious diseases and one of the most common cancers in humans, with one of the highest oncology mortality rates around the world. It is the first cause of death among cancers in men and the third in women after colon and breast cancer, causing three million deaths per year around the world. Lung cancer makes up 12% of all cancers, but causes 30% of all deaths. The one-year survival rate for patients with this disease is 42% but five-year survival is only 15%.
 
Pancreatic cancer, despite being the tenth most common one, is the fifth most deadly cancer among women in developed countries and the sixth among men. 150,000 new cases are diagnosed in developed countries each year, being the number of deaths nearly the same. This means that the mortality rate is practically 100%, making it the most lethal type of cancer: only 5% of those afflicted are still alive 2 years after being diagnosed.
 
About Ability Pharmaceuticals
 
Founded in November 2009 in Bellaterra (Barcelona), Ability Pharmaceuticals focuses on the discovery and development of anticancer drugs. Ability Pharmaceuticals (www.abilitypharma.com) has a strong pipeline focused on a new novel drug class called Lipid Analogue Therapeutics. These molecules are characterized by a selective multitarget mechanism of action that increases their efficacy with concomitant high safety. ABTL0812 is the first drug candidate entering into clinical trials; currently other candidates are in preclinical development.
 
Current shareholders of Ability Pharmaceuticals include the biotech venture capital firm Inveready based in Barcelona, its founders and private investors, and has R&D financial support from ACC10 (Government of Catalonia), CDTI and MINECO (Government of Spain). The company plans to open a development office in USA during 2014 to coordinate US clinical activities.