Cereno Scientific announced that the company has been granted approval by the FDA for Expanded Access, sometimes called "compassionate use", to investigational drug CS1 for use in an extension of the ongoing Phase II trial evaluating CS1 in pulmonary arterial hypertension (PAH). Cereno's Expanded Access Program (EAP) to drug candidate CS1 will initially be limited to patients who have completed the Phase II study in PAH. The approval of the Expanded Access Program (EAP) comes on the heels of encouraging reports emerging from the phase II study.

In July, an investigator highlighted a notable case of patient improvement with CS1. Subsequently, positive outcomes were observed during a midway study readout in October. In November, another investigator urged Cereno to submit an Expanded Access request to the FDA, seeking permission to continue administering the investigational drug, CS1, to patients post the conclusion of the study treatment.

Cereno promptly submitted the request on January 3rd, and it has now been successfully granted by the FDA. The Expanded Access Program (E AP) with CS1 in PAH provides patients who have completed the Phase I study the option to continue with CS1 drug therapy, in consultation with the investigator and subject to approval by theethics committee at the local hospital. The Expanded Access Program will provide Cereno with the opportunity to, under a formal FDA-approved protocol, collect safety and efficacy data from long-term exposure to CS1 in patients with PAH.

The EAP will thus allow Cereno to gather further documentation of CS1 use in patients suffering from PAH, which could provide valuable support to later potential applications to the FDA such as fast-track designation/breakthrough therapy as well as support to obtain the IND acceptance to start a Phase IIb/III pivotal study with CS1.