News Release:
July 28, 1999 08:21
Clinical Trial Update: STGI Announces Anticort's FDA Phase I/II is Moving Forward
LAS VEGAS--(BW HealthWire)--July 28, 1999--Dr. Alfred T. Sapse, President of Steroidogenesis Inhibitors International (OTC BB:STGI), announced today that the AIDS ReSearch Alliance has completed the screening and assessment process, and enrollment for the first cohort of patients has commenced with Anticort's pharmacokinetics and safety study in HIV-infected patients. Dr. Sapse stated "We are pleased that this important step has been accomplished, since patient enrollment is a long time consuming, frustrating process. Now, the clinical study can proceed full speed and we feel confident the results will be rewarding."
-- The AIDS ReSearch Alliance, West Hollywood, CA envisions a future in which HIV and its effects are eliminated from infected individuals. ARA's mission is to find and accelerate the development of effective treatments for HIV and its complications. ARA does this by conducting cutting edge research and clinical trials in order to improve the longevity and quality of life for all people with immune deficiency. Gregg S. Britt, CEO stated "Although significant advances have been made recently in the treatment of HIV disease, currently available anti-HIV drugs have significant shortcomings. Therefore, the pursuit of more effective, better-tolerated treatments is essential. We are pleased to be working with STGI in evaluating the effects of anticort in HIV-infected individuals." ARA is currently performing Clinical Trials for Parke-Davis, Gilead Sciences, VaxGen, Inc., Bristol-Myers Squibb, Glaxo Wellcome, and Agouron Pharmaceuticals.
SEARCHLIGHT, Summer 99, ARA's quarterly newsmagazine, featured the following article about the Anticort study, titled: ANTICORT(TM), a pharmacokinetic and safety study of procaine hydrochloride in HIV-infected patients.
AIDS Research Alliance and Steroidogenesis Inhibitors, Inc. recently announced the start of a study of the pharmacokinetics and safety of Anticort(TM)(an oral formulation of procaine hydrochloride) in HIV-infected patients treated with combination anti-retroviral therapy. This study will also compare cortisol levels in both HIV-infected and uninfected participants, and evaluate the potential immune modulating and anti-cortisol effects of Anticort(TM).
Cortisol is the dominant steroid hormone involved in carbohydrate metabolism and response to stress. Some studies have indicated that cortisol levels are elevated in HIV-infected individuals, but these studies have generally failed to consider the natural fluctuations of cortisol over the course of the day. Cortisol is widely recognized to be immunosuppressive, and elevated levels have the potential to exacerbate the immune dysfunction associated with HIV infection. One aspect of this study is to provide more information concerning cortisol level perturbations in HIV infection. This will be accomplished by comparing measures taken from blood and urine samples collected at regular intervals over a 24-hour period from both HIV-infected and uninfected participants.
Procaine has been shown in test tube experiments to inhibit the synthesis of cortisol, suggesting that it could be useful in addressing cortisol perturbations associated with HIV infection. This study has two further components to provide data on the utility of Anticort(TM) in treating cortisol perturbation in HIV infection: a pharmacokinetic evaluation of Anticort(TM), and an 8-week continuous dosing study, during which the safety and potential beneficial effects of Anticort(TM) will be evaluated in HIV-infected individuals. The purpose of a pharmacokinetic study is to provide information necessary for determining the amount and frequency of dosing.
Side Effects
Procaine (the active ingredient of Anticort(TM)) has been used clinically for more than 40 years, primarily as the local injectable anesthetic Novocaine. Despite the widespread use of procaine, reports of side effects have been rare, and are usually associated with excessive dosage, rapid absorption or inadvertent intravascular injection. Lightheadedness, irregular heart beats and allergic reactions have rarely been reported for oral procaine.
Cosyntropin will be used once per patient at the screening visit. This drug is unlikely to cause side effects when used in this manner, and allergic reaction to cosyntropin is extremely rare (although such reactions can be severe).
Dose
For the pharmacokinetics study, participants will receive Anticort(TM) at a single oral dose of 200 mg (cohort A), 400 mg (cohort B), 600 mg (cohort C) or 800 mg (cohort D). For the 8-week continuous dosing study, participants will receive 200 mg (1 pill per day; cohort A), 400 mg (1 pill twice daily; cohort B), 600 mg (1 pill three times daily; cohort C) or 800 mg (2 pills twice daily; cohort D). To ensure the safety of each dose level, these cohorts will be enrolled sequentially. Cohort E (HIV-negative individuals) will receive no medication.
Testing
The study begins with a screening visit, which will include an assessment of participants' adrenal function (the gland that produces cortisol). Since part of this study involves the documentation of cortisol level alterations associated with HIV infection, cortisol measurements need to be performed on participants with normal values of adrenal gland function. Normally functioning glands will respond to an intramuscular injection of the synthetic hormone cosyntropin with increased secretion of cortisol. Only those with normal responses to the cosyntropin test will be allowed to continue in this study.
Pharmacokinetics and Cortisol Measurement Study (HIV-Positive and HIV-Negative Individuals)
This component of the study requires participants to be admitted to an intermediate care facility, for 3 days. For all participants, one evening (considered 1 day) will be spent accommodating to the facility. Blood and urine samples will be collected at regular intervals throughout the second day for the measurement of cortisol levels. Following this, the HIV-negative participants (cohort E) will be discharged from the study.
For cohorts A, B, C and D, the third and final day will consist of the evaluation of the pharmacokinetics and anticortisol action of Anticort(TM) in the HIV-positive participants. Participants in these cohorts will receive their entire daily dose at once, and then blood and urine will be collected at regular intervals over the next 24 hours for the measurements of cortisol and the pharmacokinetics of Anticort(TM).
Continuous Dosing Study (HIV-Positive Individuals Only)
One week following the pharmacokinetic study, participants will begin taking Anticort(TM) daily at doses that vary for the different cohorts. Safety, viral and immunological data will be assessed from visits at weeks 1, 2, 3, 4, 6, 8 and 10 of this component of the study. At week 8, the pharmacokinetic measurements will be repeated for cohorts A, B, C and D.
Inclusion Criteria (Partial List)
(1) HIV-positive individuals for cohorts A, B, C and D. HIV-negative individuals for Cohort E.
(2) Since cortisol levels vary with menstrual cycles, only men will be enrolled.
(3) 18 years of age or older.
(4) CD4 count > 200.
(5) On stable retroviral therapy (cohorts A, B, C and D) for 8 weeks and willingness to not start any new antiretrovirals or immunomodulators during the trial.
Exclusion Criteria (Partial List)
(1) Known or suspected allergy to procaine hydrochloride.
(2) Patients using sulfonamides (including Septra/Bactrim), DHEA supplementation, oral Ketoconazole, or cholinesterase inhibitors.
(3) Abnormal adrenal function, as assessed during the screening test.
Compensation
This study involves several overnight inpatient visits. Participants will therefore be compensated for volunteering their time in this study.
Number of Patient Slots
30 (6 per cohort). These include 24 HIV-positive and 6 HIV-negative individuals.
Status
Currently enrolling
Principal Investigator
Stephen J. Brown, M.D.
This release may include "forward-looking statements" within the meaning of section 27A of the Securities Act of 1933 and section 21E of the Securities Act of 1934. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable; it can give no assurance that such expectations will prove correct. This is neither an offer to buy or sell a security. For informational purposes only, from sources deemed to be reliable.
CONTACT: Steroidogenesis
Janet Greeson, Ph.D, 702/222-1988
or
Performance Strategies, Inc.
Richard L. Brown, 303/948-3601
or
Chuck Jordan, 303/948-3601 |
