NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

senti, ex is just being ex. The company is APAC Biotech, and the “product” is an autologous monocyte-derived mature dendritic cell therapy called APCEDEN® that was approved based on the single-arm, phase II, ATTEST trial in India, and only approved in India because it wouldn’t pass the rigors of approval anywhere else. The results were published in the Journal of Cytotherapy in 2014. https://www.celltherapyjournal.org/article/S1465-3249(13)00786-X/pdf

Here’s an excerpt:

A total of 51 patients were enrolled for study and qualified as an intention-to-treat population. Thirteen patients died before they could receive the first dose, hence, 38 patients who received at least one dose were evaluated for safety and response. A total of 12 patients completed the study, which included six doses of DC immunotherapy and two post-treatment follow-ups in the course of 12 weeks.

Each sex had equal representation. Median age was 53 years. Most cases had multiple chemotherapy failure and metastatic disease. Most patients enrolled had cancer of the ovary, followed by colon and head and neck cancer. On-going co-morbid conditions such as hypertension, diabetes, chronic obstructive pulmonary disease and coronary artery disease were controlled with medication. A total of 14 different types of solid cancer were studied (Figure 4).

To analyze comparative data, the patients were divided into three cohorts. Cohort I included patients with progressive disease (PD), cohort II included patients with objective response (OR) and cohort III included non-evaluable patients; these were early dropouts and did not undergo response evaluation. Progression-free survival and overall survival were calculated from the date of enrollment and date of first infusion, respectively.

Baseline characteristics, source of antigen and instrument response of patients with OR are summarized in Table I. The cutoff date for analysis of data was December 5, 2012.

Safety and tolerability
Of 51 patients enrolled, 38 cases were evaluated for safety and efficacy, because 13 subjects died before the first dose could be given. Patients receiving at least one dose were evaluated for safety and response evaluation. In all, 225 infusions were administered and all were well tolerated, barring only one incident of chills and rigors associated with mild pyrexia reported during a single infusion. The patient continued on the study; symptoms were resolved and did not reappear during subsequent infusions. According to investigators, this could have been “possibly related” to study therapy.