Cell Therapeutics, Inc. (NASDAQ: CTIC) has announced what may be a large breakthrough in the fight against cancer. This is a combined test rather than as a standalone treatment, but the result may be a huge step in cancer of the lower esophagus. As many of the ties of one cancer are made to others, you can imagine that the hope might be that this would have other possibilities as well in the fight against other or related cancers.
The company said that a study from Brown University to be presented in the proffered oral session at the Annual Meeting of the International Society of Gastrointestinal Oncology in Philadelphia patients with cancer of the lower esophagus showed a high rate of complete remission when given OPAXIO(TM). This is paclitaxel poliglumex, which is a biologically enhanced paclitaxel. This result was shown when OPAXIO was administered in combination with standard cisplatin and concurrent radiation.
Cell Therapeutics noted that the phase II study was led by Dr. Safran and enrolled 40 patients with pathologically-confirmed and locally-advanced adenocarcinoma or squamous cell carcinoma of the esophagus or gastro-esophageal junction with no evidence of distant metastasis. These 40 patients received weekly paclitaxel poliglumex and cisplatin for six weeks with concurrent radiation. Of the first 28 patients undergoing surgery, all 8 of the 28 with adenocarcinoma have achieved a pathologic complete remission. No patients required a feeding tube, which differs from historical studies using the standard regimen where the large majority of patients require a feeding tube.
The company said that Paclitaxel poliglumex’s selective radiation enhancement preclinical profile is being validated by the high rates of pathologic complete remission, and by low rates of severe regional side effects observed in this phase 2 study. It also noted that the results justify proceeding to a randomized, controlled trial to definitively prove the clinical benefit observed. It also plans to speak with the FDA regarding a potential phase III registration strategy for this indication. Further noted is that this would ‘be the first registration study for a radiation sensitizing agent in this indication.’
As this is a $1.23 stock and has a 52-week trading range of $0.05 to $2.28, you can imagine there will be a lot of trading around this small cap name on Thursday. Additional results and safety data is offered below.
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