Ampio to request approval from the FDA for the treatment of pain due to severe osteoarthritis of the knee.
ENGLEWOOD, Colo., June 30, 2016 /PRNewswire/ — Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) announced today the results of the Ampion™ PIVOT clinical trial as well as a comprehensive analysis that integrates trial data from three single injection studies that will be presented to the FDA.
The PIVOT trial, which included 480 patients, was a double-blind saline-controlled phase III clinical trial performed in 20 sites across the US to examine the safety and efficacy of Ampion™ intra-articular injection in patients with pain due to osteoarthritis (OA) of the knee. The primary endpoint was the change in WOMAC A pain at week 12 as compared to saline. Additional analyses included adverse events (AEs), Patient Global Assessment (PGA), and responder status defined as 20% improvement in pain at week 12.
Ampion™ was demonstrated to be safe and well-tolerated with no drug-related serious AEs and an overall AE rate that was similar in the Ampion™ and saline groups. OA severity was defined by the Kellgren Lawrence scale (KL). Ampion™ improved WOMAC A pain significantly over baseline in all KL grades (KL 2: 52%, KL 3: 36%, and KL 4: 33% reductions in pain) but the primary end point was not met. The Company observed the largest differentiation between Ampion™ and saline in the most severe OA patients (KL 4), where no available non-surgical therapy exists. KL 4 patients have been historically excluded from knee OA trials because of the advanced stage of their condition.
Ampio to seek FDA approval
A comprehensive analysis that integrates trial data from three single injection studies demonstrates patients with KL 4 severity have significant benefit with Ampion™ over saline in more than 400 patients. The analysis showed statistically significant improvement:
WOMAC A pain (p = 0.016)
Patient Global Assessment (p = 0.001)
Responder status (p = 0.006)
Safety data will be presented to support the clinical benefit, as there were no drug-related safety issues observed.
Mr. Macaluso, Ampio’s CEO stated, “Ampio has the opportunity to provide treatment where there is a clear unmet medical need. Even though we did not meet the primary end point in the PIVOT study, we are pleased with the consistent effect Ampion™ demonstrated in all of our clinical trials. Ampio is requesting a meeting with the FDA to present our data in support of Ampion™.”
Ampio will host a conference call at 4:30pm ET on Tuesday, July 5th. Participants are invited to dial in using the instructions as follows:
Investor call information:
U.S./Canada toll-free number: 866-675-4790
International toll number: 913-312-0685
Participant Passcode
tornare VERDE seppure di un solo tick. Che è manovrata è lampante e bisogna solo avere la fortuna spesso di stare nel lato giusto dato che a noi poveri mortali non è dato di influire, non ha caso veniamo chiamati "parco buoi" poi se uno si trova dentro e ne sa approfittare non vuol dire che sia un luminare di finanza. Non sto capendo bene sto cazzz di AYTU che altre manovre sottointende. Ieri uscita una news che lo ha portato stabilmente a 0,3$ 
