Updated trial description information for ReACT on clinicaltrials.gov website
Here are the two most important changes made on August 15, from what I could tell, after it was announced that the trial is being expanded. The expansion group is labeled "Group 2C".
1) For primary outcome measure:
"Group 2C: Objective Response Rate [ Time Frame: Every 8 weeks from Day 1 through progression or initiation of other anti-cancer therapy ] [ Designated as safety issue: No ] Evaluate the anti-tumor activity of rindopepimut in adult patients with relapsed glioblastoma, as measured by the objective response rate (ORR) for patients with measurable disease at study entry."
2) For secondary outcome measure:
"Anti-tumor activity [ Time Frame: During treatment and every 8 weeks through follow up ] [ Designated as safety issue: No ] Evaluated by comparing the treatment regimens for anti-tumor activity, including objective response rate, overall progression free survival (PFS), and overall survival (OS) for Groups 1 and 2; and PFS6, overall PFS, and OS for Group 2C."
The addition of evaluating PFS6 in Group 2C, whereas Groups 1 and 2 are only being evaluated for PFS, might mean that the six-month time frame has been determined to be significant in patients that have already been treated and observed.
You can easily find the entire trial description on the clinicaltrials website and read it for yourself.
Wow. So much is happening with CLDX. Think of the market cap of Celgene while thinking about this new trial:
Recruiting DEC-205/NY-ESO-1 Fusion Protein CDX-1401and Decitabine in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia Conditions: Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Chronic Myelomonocytic Leukemia; de Novo Myelodysplastic Syndromes; Previously Treated Myelodysplastic Syndromes; Recurrent Adult Acute Myeloid Leukemia; Refractory Anemia With Excess Blasts in Transformation; Untreated Adult Acute Myeloid Leukemia
Interventions: Biological: DEC-205/NY-ESO-1 fusion protein CDX-1401; Drug: poly ICLC; Drug: decitabine; Other: laboratory biomarker analysis
There wa no PR from Celldex because Roswell is running the trial. However, as the word spreads CLDX should benefit. Next week I'm confident of a close over $22. Today's MF article only adds fuel to the fire.