Delcath Systems, Inc (NASDAQ:DCTH) has moved ahead to state that the Food And Drug Administration has given approval to its design of a clinical trial for its Melphalan/HDS drug product and that is of course in line with Special Protocol Assessment.
As a matter of fact, A Special Protocol Assessment (SPA) happens to be a procedure through which the FDA comes up with an official evaluation and confirmation for a yet-to-be-completed Phase 3 trials design, clinical endpoints, protocols as well as statistical analysis in a bid to form ground for a New Drug Application.
Melphalan/HDS (short for Melphalan Hydrochloride for Injection) which is combined with Delcath’s Hepatic Delivery System, happens to be Delcath’s drug which is specifically designed in a bid to try and administer top and trusted chemotherapy doses to the liver.
As a matter of fact, to this particular point the Melphalan/HDS system hasn’t yet received approval in the U.S, but one thing that is for sure is the fact that it is seen as a combination drug-and-device product.
The agency’s SPA nod has gone ahead to say that the trial design in an adequate way addresses the set goals for evaluating Melphalan/HDS for handling the wide range of patients with intrahepatic cholangiocarcinoma (ICC).According to some close sources, about 295 patients are expected to be enrolled in the global trial at 40 different sites in Europe and in the U.S.
There are hopes that by the fall of 2017 the trial will have kick started and as a matter of fact it will bear the overall survival (OS) as its primary endpoint.
Measures of progression-free survival (PFS), safety as well as overall response rate (ORR) are expected to constitute the wide array of the exploratory and secondary endpoints. It is also important to point to the fact that it isn’t easy to reach the point the provider has reached at the moment since on the way it is usually marred by numerous challenges.
In fact there comes a moment when efforts appear like the drawing of lines in the sand. However, the top notch provider has remained dedicated to coming up with top most solutions and for sure the future looks quite promising.