Ability Pharma successfully completes phase 1/1b clinical trial of ABTL0812 in advanced cancer patients with solid tumors
<p>The results come on the heels of the drug receiving FDA designation as an orphan drug</p>
Ability Pharmaceuticals, a Catalan biopharmaceutical firm specializing in the development of cancer drugs, has announced positive results from its clinical trial of drug ABTL0812 in advanced cancer patients with solid tumors. The study was conducted at Hospital Clinic Barcelona and the Catalan Institute of Oncology (ICO), and will allow the company to move on to the second clinical phase of the project.
“If all goes well, we’ll start phase II in February of next year. That’s why we’ve opened a new round of funding. We need €4.5 millions immediately,” explains CEO Carles Domenech. “The results are very good. We’ve proven the drug’s safety and tolerability, which is the most important. And, above all, long-term stabilization in the progression of the cancer.”
The first phase of the trial was conducted with 29 advanced cancer patients with solid tumors and in one of these cases, the diseases was stabilized for up to 14 months. For phase II, which will be conducted with less advanced patients, the outlook is even more optimistic. The main researchers conducting the study were Dr. Laura Vidal and Dr. Pere Gascón, of Hospital Clinic Barcelona, and Dr. Marta Gil-Martín of the Hospital Duran i Reynals Catalan Institute of Oncology (ICO).
ABTL0812 is a first-in-class molecule and a PI3K/Akt/mTOR (PAM) pathway inhibitor with a new mechanism of action, unlike any other PAM inhibitors. Neuroblastoma is a highly uncommon cancer of the nervous system that affects children and infants, mostly in the abdominal region. It makes up between 6% and 10% of all childhood cancers and has a mortality rate of approximately 15%.
The US Food and Drug Administration (FDA) already gave the molecule Orphan Drug Designation (ODD) earlier this month and Ability Pharma is also hoping to get a Positive Scientific Assessment from the European Medicines Agency (EMA) for its development, as the EMA granted the drug ODD status in April to treat neuroblastoma.
More information is available in the press release
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