title: Phase II study of the novel peptide-nucleic acid OHR118 in the management of cancer-related anorexia/cachexia.
abstract: OBJECTIVE
  OHR118 represents a new class of immunomodulatory and cytoprotective drugs in managing anorexia cachexia. Previously in patients with advanced HIV-AIDS, increases in appetite, strength, and alertness were noted. The objective was to determine the effect of OHR118 on appetite, early satiety, and nutritional intake in patients with advanced cancer. Secondary end points included changes in performance status, lean muscle mass, and quality of life (QOL).
  
  
  METHODS
  Eligible patients received 4.0 mL of OHR118 in subcutaneous daily injections. Patients underwent bi-monthly evaluations during the 28-day initial treatment (phase A). Evaluations included Karnofsky performance status, Edmonton Symptoms Assessment Scale (ESAS), Patient-Generated Subjective Global Assessment (PG-SGA), Simmonds Functional Assessment (SFA), Dyspepsia Symptom Severity Index (DSSI), weight, lean body mass, skin fold thickness, and grip strength. Patients who benefited from phase A could elect to continue with therapy (phase B).
  
  
  RESULTS
  Of 21 enrolled patients, 11 completed phase A. Eight patients chose to continue with OHR118 treatment (phase B). Weight stabilization or gain was observed in 7 of 11 patients. Total PG-SGA scores improved significantly (P ≤ .01). Appetite (P ≤ .01) and depression (P = .05) scores improved on ESAS. Frequent burping/belching (P = .02), feeling full (P = .04), and stomach distention (P = .03) improved on the DSSI. A deterioration in the timed sit to stand was noted (P = .01). OHR118 was well tolerated with no serious side effects reported.
  
  
  CONCLUSIONS
  OHR118 again mediated statistically significant improvements in anorexia, dyspepsia, strength, and depression in this trial, consonant with the previous AIDS trial results.
authors.affiliation: Division of Palliative Care, University of Ottawa, Canada. MChasen@bruyere.org
authors.forename: Martin
authors.initials: M
authors.lastname: Chasen
authors.forename: Shalom Z
authors.initials: SZ
authors.lastname: Hirschman
authors.forename: Ravi
authors.initials: R
authors.lastname: Bhargava
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000855:Anorexia / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D001066:Appetite / Q000187:drug effects*; D002100:Cachexia / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D004435:Eating / Q000187:drug effects; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications*; D009696:Nucleic Acids / Q000494:pharmacology / Q000627:therapeutic use*; D020135:Peptide Nucleic Acids / Q000494:pharmacology / Q000627:therapeutic use*; D010455:Peptides / Q000494:pharmacology / Q000627:therapeutic use*; D011788:Quality of Life; D012528:Satiety Response / Q000187:drug effects; D055815:Young Adult
chemical_list: C469610:EOM613; D009696:Nucleic Acids; D020135:Peptide Nucleic Acids; D010455:Peptides