Potential Breakthrough in Esophagus Cancer (CTIC)

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.


JON C. OGG

Concurrent chemotherapy with 50.5 Gy of radiation is the standard pre-surgical therapy for patients with potentially resectable, locally-advanced esophageal cancer. Although the addition of chemotherapy to radiation is beneficial, the cure rate for esophageal cancer is low. Standard neoadjuvant treatment for esophageal cancer uses a regimen of cisplatin, and fluorouracil (5-FU) chemotherapy with concurrent radiation, which is a regimen associated with a high incidence of Grade 3-4 toxicity to the upper gastrointestinal track necessitating prophylactic insertion of feeding tubes. Published preclinical studies have demonstrated that, unlike standard paclitaxel and other chemotherapeutic agents that enhance radiation killing by a factor of 1.5 to 2.0, OPAXIO increases tumor specific radiation cell kill by a factor of 7.2 to 8.4-fold (Milas Luka et al, Poly(L-glutamic acid)-paclitaxel conjugate is a potent enhancer of tumor radiocurability, Int’l J. Radiat. Oncol. Biol. Phys. 55(3), 707-12 (2003)).
nutrition. No patients developed neuropathy.parenteral was given total subsequently in only one patient who was reported (n=2), fatigue (n=2), glucose intolerance (n=2), and hypersensitivity reaction (n=1). Grade 3 anorexia dysphagia. Eleven of 35 patients had grade 3 non-hematologic toxicities including electrolyte abnormalities (n=5), nausea (n=3), thromboembolus toxicities, which included electrolyte abnormalities, glucose intolerance, hypersensitivity reaction and non-hematologic (n=2) and anemia (n=1). Four of 35 patients experienced grade 4 neutropenia toxicities; grade 3 hematologic toxicity included hematologicThere were no grade 4