Celsion Corporation (NASDAQ:CLSN) announced that the independent Data Safety Monitoring Board (DSMB) has completed its safety review of data from the first three patient cohorts in the ongoing Phase Ib OVATION Study. Based on the DSMB’s recommendation, the study will continue as planned and the Company will proceed with dosing in its fourth and final patient cohort at an escalated dose. The OVATION Study is a dose-escalating clinical trial combining GEN-1, the Company’s DNA-based immunotherapy, with the standard of care for the treatment of newly-diagnosed patients with advanced ovarian cancer who will undergo neoadjuvant chemotherapy followed by interval debulking surgery.
“The DSMB’s recommendation and the lack of any dose limiting toxicities in the trial to date underscore the improved tolerability of GEN-1 over recombinant IL-12 protein-based therapies,” said Nicholas Borys, M.D., senior vice president and chief medical officer of Celsion. “The favorable safety profile we have seen thus far is consistent with the translational data that we reported earlier this year, which show that GEN-1 produces a sustained, localized secretion of IL-12 protein and avoids the high levels of systemic exposure which have limited the development of recombinant IL-12 therapies in the past.”
“We could not be more excited to progress with the OVATION Study and look forward to reporting clinical findings from the third patient cohort, as well as translational data from the first two cohorts, early in the fourth quarter. Furthermore, we expect to report final data from this highly promising study in the first quarter of 2017,” saidMichael H. Tardugno, Celsion’s chairman, CEO and president. “We have been encouraged, as have been our Investigators, by the findings to-date in this difficult-to-treat patient population. As we have previously reported, all six patients in the first two cohorts experienced a clinically meaningful response, ranging from stable disease to one pathologically confirmed complete response. In addition, we saw sustained decreases of 90% or greater of the prospective indicator of the presence of ovarian cancer cells, CA-125 protein, in all patients, as well as highly impressive pathologically responses, which is associated with prolonged survival.”
The OVATION Study is designed to enroll three to six patients per dose cohort at escalating doses of GEN-1 with the goal to identify a safe, tolerable and therapeutically active dose of GEN-1 by recruiting and maximizing an immune response. The first three cohorts each enrolled three patients. Enrollment in the fourth and final cohort is underway, and Celsion expects to report full data from the OVATION Study by the first quarter of 2017. Future studies of GEN-1 will include a Phase I/II study combining GEN-1 with Avastin® and Doxil®. (Original Source)
Shares of Celsion are up nearly 3% to $1.28 in pre-market trading. CLSN has a 1-year high of $2.31 and a 1-year low of $1.04. The stock’s 50-day moving average is $1.24 and its 200-day moving average is $1.36.
On the ratings front, Celsion has been the subject of a number of recent research reports. In a report issued on August 15, Maxim Group analyst Jason McCarthy reiterated a Buy rating on CLSN, with a price target of $4.00, which represents a potential upside of 223% from where the stock is currently trading. Separately, on July 26, H.C. Wainwright’s Swayampakula Ramakanth reiterated a Buy rating on the stock and has a price target of $3.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jason McCarthy and Swayampakula Ramakanth have a total average return of -1.6% and -12.4% respectively. McCarthy has a success rate of 38.0% and is ranked #3361 out of 4151 analysts, while Ramakanth has a success rate of 31.5% and is ranked #3986.
Celsion Corp. is an oncology drug development company focused on developing a portfolio of innovative cancer treatments, including directed chemotherapies, DNA-mediated immunotherapy and RNA- based therapies. Its products include Celsion, ThermoDox, EGEN, TheraPlas and TheraSilence.