The first human trial for gene transfer therapy for the treatment of erectile dysfunction: Preliminary results

Arnold Melman, Natan Bar-Chama, Andrew McCullough, Kelvin Davies, George Christ

Research output: Contribution to journalArticle

52 Scopus citations

Abstract

Objective: To test the safety of a single intracavernous injection of a plasmid vector (hMaxi-K) that expresses the hSlo gene, that encodes the α-subunit of the Maxi-K channel, for the treatment of erectile dysfunction (ED). Methods: Six men, thus far have fulfilled the entry criteria of the protocol and had gene transfer with hMaxi-K. Three received a dose of 500 μg and three received a dose 1000 μg of the gene product, injected intracavernously as naked DNA. Dosing at 5000 μg and higher is planned. Results: The primary end point of the phase I trial is safety. No drug-related adverse events or significant laboratory changes have occurred after the gene transfer. Moreover, there is no evidence of the gene in semen at the one copy per μg total DNA in any of the participants. Conclusion: Preliminary results indicate that, in a single dose escalation study, ion channel gene transfer with hMaxi-K can be administered safely to men with ED without adverse events.

Original languageEnglish (US)
Pages (from-to)314-318
Number of pages5
JournalEuropean Urology
Volume48
Issue number2
DOIs
StatePublished - Aug 1 2005

Keywords

  • Erectile dysfunction
  • Gene transfer
  • Ion channel therapy
  • Maxi-K channel
  • Naked DNA
  • Potassium channels
  • Smooth muscle
  • hMaxi-K

ASJC Scopus subject areas

  • Urology

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