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Related Experiment Videos

PHP-HT (VitaResc Biotech).

A Baldwin1, E Wiley

  • 1College of Medicine, Department of Physiology, University of Arizona, Tucson, AZ 85724-5051, USA. abaldwin@u.arizona.edu

Idrugs : the Investigational Drugs Journal
|July 15, 2005
PubMed
Summary
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Pyridoxalated hemoglobin polyoxyethylene conjugate (PHP-HT) is being developed to treat nitric oxide-induced shock, particularly septic shock. Early trials are complete, with ongoing dose escalation studies informing future pivotal trials for this potential blood substitute.

Area of Science:

  • Biomedical Engineering
  • Pharmacology
  • Critical Care Medicine

Background:

  • Nitric oxide-induced shock, a condition of hypotension, requires novel therapeutic interventions.
  • Pyridoxalated hemoglobin polyoxyethylene conjugate (PHP-HT) is a modified hemoglobin-based oxygen carrier developed as a potential blood substitute.
  • VitaResc is advancing PHP-HT for shock treatment, building on Ajinomoto's original development.

Purpose of the Study:

  • To evaluate the safety and efficacy of PHP-HT in patients experiencing nitric oxide-induced shock.
  • To establish optimal dosing and administration protocols for PHP-HT through dose escalation studies.
  • To lay the groundwork for a pivotal phase II/III trial to confirm PHP-HT's therapeutic potential.

Main Methods:

  • Phase I safety studies and initial phase I/II patient trials have been conducted.

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  • Ongoing trials involve patient enrollment in dose escalation cohorts with continuous infusion protocols.
  • Results from dose escalation are intended to guide the design of a randomized, controlled phase II/III trial.

    • Main Results:

    • Phase I safety study and initial phase I/II patient trials for NO-induced shock have been completed.
    • Patients have been enrolled in three of five planned cohorts for ongoing dose escalation studies.
    • Results are anticipated to support the initiation of a larger, pivotal clinical trial.

    Conclusions:

    • PHP-HT shows promise as a treatment for nitric oxide-induced shock, with initial trials providing a basis for further development.
    • Ongoing dose escalation studies are critical for determining the optimal therapeutic regimen.
    • The successful development of PHP-HT could address a significant unmet need in critical care, with potential applications beyond septic shock.