News & Media

Research Article, March 2016

A national, multi institutional, Phase Ia,b clinical trial of p28 as a single agent in pediatric patients with recurrent or progressive CNS tumors sponsored by the Pediatric Brain Tumor Consortium (PBTC-041) and the NCI-CTEP was published in Neuro-Oncology.

Phase 1 trial of p28 (NSC745104), a non-HDM2-mediated peptide inhibitor of p53 ubiquitination in pediatric patients with recurrent or progressive central nervous system tumors: A Pediatric Brain Tumor Consortium Study.

Neuro Oncol., 2016 Mar 28. pii: now047. [Epub ahead of print]

Press release, March 2016

On March 1, 2016 CDG Therapeutics Inc.,  a clinical stage biopharmaceutical company focused on discovering and developing novel cell-penetrating therapeutic peptides for cancers and allied diseases, released that the U.S. Food and Drug Administration (FDA) granted orphan drug designation for CDG28 (p28), the Company’s lead candidate after a successful Phase I trial in progressive or refractory pediatric brain tumors. CDG28 readily crosses the blood brain barrier, preferentially enters brain tumor cells and exerts efficacy with no significant, drug related, adverse effects. The FDA also designated CDG28 for the treatment of rare pediatric diseases; diffuse intrinsic pontine glioma (DIPG).

American Society of Clinical Oncology (ASCO), May 2015

A final report of pediatric Phase I clinical trial of p28 will be presented at the 2015 meeting of the American Society of Clinical Oncology (ASCO), Chicago, IL.

Title: Phase 1 Trial of p28 (NSC745104), a Non-HDM2 Mediated Peptide Inhibitor of p53 Ubiquitination in Children with Recurrent or Progressive CNS Tumors: A Final Report from the Pediatric Brain Tumor Consortium. Abstract # 10059

Phase I Trial Update

A new phase I trial has shown that a small, 28-amino-acid peptide called p28, which stabilizes p53 (encoded by TP53) to protect it from degradation, is well-tolerated in patients with advanced solid tumours. The work—a first-in-class, first-in-human trial—also demonstrated that some tumour control could be achieved. Targeted therapies: One step closer to drugging p53.

Razzak M. Nat Rev Clin Oncol. 2013 10(5):246. doi: 10.1038/nrclinonc.2013.43.

CDG Therapeutics, Inc. Announces “First in Class, First in Human” Clinical Phase I Trial Results of Cell-Penetrating Peptide, p28

Azurin-derived peptide shows preferential cancer cell entry without serious safety effects

CHICAGO, IL – June 6, 2011 – CDG Therapeutics, Inc. ( today announced results from a Clinical Phase I trial of a novel platform technology utilizing p28, a synthetic, anionic cell penetrating peptide. Fifteen refractory (Stage IV) solid tumor patients with p53+ lesions were enrolled in an escalating, five-dose level (.83, 1.66, 2.5, 3.33, and 4.16 mg/kg) Phase I trial to evaluate the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics (PK/PD) of p28 as a single agent. The data was presented at this week’s American Society of Clinical Oncology (ASCO) annual meeting in Chicago. (more…)