1. Dr. Corrigan initiated the Phase 2a trial for chronic neuropathic pain associated with Lumbosacral Radiculopathy (LSR) on September 4, 2012, with a target of 140 patients from 25 clinical sites in the United States. He knew that this trial would enroll more rapidly than the PHN trial from the outset because of the contract research organization (CRO) time estimate and price.
2. From the beginning, the contract research organization (CRO) quoted a higher price for enrolling the same number of patients (140) for the Postherpetic Neuralgia (PHN) trial because finding patients that fit the enrollment criteria is more challenging and required more study locations. The PHN trial had a target of 140 patients from 55 clinical sites in the United States and began on January 3, 2013.
3. Top line data was stated to come out in the SECOND HALF of 2013. ZALICUS INC. filed this Form 8-K on 03/06/2013: "Top line data from both studies are expected to be available late in the SECOND HALF of 2013."
4. Top line data was stated to come out in the SECOND HALF of 2013. ZALICUS INC. filed this Form 8-K on 05/02/2013 "Top line data from both studies are expected to be available late in the SECOND HALF of 2013."
5. Press release of Zalicus Inc. dated August 1, 2013: “Enrollment is going well in the two Phase 2 clinical trials of Z160 for the potential treatment of chronic neuropathic pain, including lumbosacral radiculopathy and postherpetic neuralgia and we remain on track to report top line data from both studies in the fourth quarter of 2013."
Phase 2 Efficacy Trial of Z160 in LSR
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: OCTOBER 2013 (Final data collection date for primary outcome measure)
Efficacy and Safety Study of Z160 in Subjects With PHN
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: DECEMBER 2013 (Final data collection date for primary outcome measure)
Dr. Corrigan knew full well that the PHN trial would take longer to enroll and be more expensive because the CRO told him.
JASON NAPODANO STARTED THE PHN "SPEND MORE TO CATCH UP WITH LSR" RUMOR:
Jason stated: "LSR started enrollment 3 months ahead of PHN, but the PHN study is the standard "proof-of-concept". Above I talk about how when the PHN study started then had 25 centers. Now they are up to 53. That was clearly designed to accelerate PHN to catch-up with LSR."
When in fact the original press release stated:
"The second Phase 2a study with Z160 is enrolling subjects with Postherpetic Neuralgia (PHN), a chronic neuropathic pain state resulting from an outbreak of the herpes zoster virus, otherwise known as shingles. Due to this prolonged neuropathic pain, PHN is an industry-accepted standard condition for establishing clinical proof-of-concept for pharmaceutical product candidates seeking to address neuropathic pain. The 6-week, double-blind, multi-center, randomized, placebo-controlled study is expected to enroll approximately 140 subjects and will be conducted in approximately 35 centers throughout the United States. " 8-K ZALICUS INC. filed this Form 8-K on 01/03/2013.
Dr. Corrigan knew from the day the study started it would start with 10 more centers than the LSR trial.
There is no evidence in the history record of the PHN trial that Dr. Corrigan added sites beyond what was originally planned.
So, Jason Napodano got his facts wrong. Zalicus enrollment for PHN started with 10 more sites than LSR from the first days with more sites planned because PHN is more difficult to enroll than LSR. If Dr. Corrigan wanted PHN to finish before LSR, he would have started the PHN trial first, BUT HE DID NOT.
LSR is schedule to come off in October whereas PHN is scheduled to have primary completion in December. Enrollment calculations put LSR results on target for October 7, 2013. If LSR did not meet its endpoint, an announcement will be delayed and released with the PHN results. Why PHN was not scheduled to come off first probably has to do with the price and cash income from cHTS.