Amarillo Biosciences, Inc. Announces a Clinical Trial in Patients With Bone Marrow Disorders
Posted on: Thursday, 10 March 2005, 12:00 CST
Amarillo Biosciences, Inc. (ABI) (OTC BB: AMAR) today announced that a study will commence to test low dose oral interferon alpha in forty patients with rare bone marrow proliferative disorders. The study will be conducted at a major cancer center in Texas with a leading medical authority who specializes in the treatment of these myeloproliferative disorders. Twenty patients, each with either polycythemia vera (PV) or primary thrombocythemia (ET), will be given low dose oral interferon alpha daily as a treatment to relieve the signs and symptoms associated with these disorders.
In 1997-1998, Amarillo Biosciences, in conjunction with a leading Midwestern medical center, conducted a 48-week pilot study in the treatment of PV and ET. Human interferon alpha lozenges were administered once daily to 7 PV and 6 ET patients. Because of the benefits noted in the pilot study, and because so few good treatment alternatives exist, this follow-up study is planned to commence in the second quarter of this year. The principal investigator, after conducting a review of previous studies, has determined that administering the interferon lozenges three times daily should maximize the potential efficacy of the therapy.
PV and ET are stem cell disorders considered to be incurable. Treatment is directed at reducing morbidity and preventing life-threatening complications. The clinical course of both ET and PV are characterized by vasomotor disturbances (headaches, dizziness), acral dysesthesia (impaired sensations in limbs, fingers, ears), erythromelalgia (diffused redness and atrophy of skin on legs), visual symptoms, thrombohemorrahagic (inappropriate clotting) events, and the risk of transformation into acute myeloid leukemia (AML) or fibrosis of the bone marrow (myelofibrosis).
Treatment efforts in ET strive to reduce clotting events in patients at high-risk for thrombosis without increasing the intrinsically low risk of developing leukemia. All patients with PV require phlebotomy (drawing blood), with the goal of reducing hematocrit levels (the concentration of red blood cells). This maneuver prolongs survival by decreasing the risk of thrombosis. The goal of therapy in PV is not only to prevent thrombosis, but also to reduce the risk of transformation into AML or myelofibrosis.
In the previous 1997-1998 study, treatment response in PV patients was based on changes in hematocrit levels and phlebotomy requirement. Four of 7 subjects had a greater than or equal to 50% reduction in phlebotomy requirement, compared to the 6 months prior to the study, and consequently were considered partial responders. Response in the ET subjects was based on changes in platelet count. One of 6 subjects experienced normalization of platelet count (complete response), 3 were unchanged and 2 experienced a progression of disease during interferon alpha lozenge therapy. No deaths or serious adverse events occurred in this study.
About Amarillo Biosciences, Inc.
Amarillo Biosciences, Inc., is a U.S. biotechnology firm operating in global partnership with the Hayashibara Group, which also holds 20.6% of Amarillo Biosciences shares and has provided over $16.5 million in loans, grants and equity investments. The Company's primary focus is extensive and ongoing R&D into the use of low-dose, orally administered interferon as a treatment for a variety of conditions, including Sjogren's syndrome, Behcet's disease, and opportunistic infections in patients who are HIV positive. In its 20-year history, ABI has invested nearly $37 million to establish oral interferon as a therapeutic agent. The overwhelming majority of those funds were invested in clinical trials in an effort to achieve FDA approval for interferon. Additional information is available on the ABI web site at http://www.amarbio.com/.
Except for the historical information contained herein, the matters discussed in this news release are forward-looking statements that involve risks and uncertainties, including uncertainties related to product development, uncertainties related to the need for regulatory and other government approvals, dependence on proprietary technology, uncertainty of market acceptance of oral interferon or the Company's other product candidates and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission. In particular, see "Item 1. Description of Business" of the Company's Form 10-KSB for the year ended December 31, 2003.
Investor Relations: Philippe Niemetz WPH Consultants, Ltd. Tel: 800-477-7570 Tel: 212-344-6464 Fax: 212-618-1276 e-mail: philippe.niemetz@wphconsultants.com Joseph M. Cummins, DVM, PhD Amarillo Biosciences, Inc. Tel: 806-376-1741 x 13 Fax: 806-376-9301 e-mail: jcummins@amarbio.com
SOURCE: Amarillo Biosciences, Inc.
Source: MARKET WIRE
Related Articles
- Study Suggests Dentists Can Identify Patients At Risk For Fatal Cardiovascular Event
- Researchers Find Potential Patient Safety Risks Among Methadone Maintenance Treatment Patients
- Treatment delays can put patients at risk
- Prometheus Announces New Findings Regarding Patients at Risk for Celiac Disease at DDW
- Analysis of Six Clinical Trials Finds EPZICOM(R) Effective in Treatment-Naive HIV Patients With Both High and Low Baseline Viral Loads
- New Data Reveals That Enoxaparin Results in Significant Cost Savings Compared to Unfractionated Heparin (UFH) in Treatment of in-Hospital Patients at Risk for Venous Thromboembolism (VTE)
- Studies Show Schizophrenia Patients Taking Atypicals Stayed on Treatment Longer Than Patients Taking Older, Typical Antipsychotics
- Idenix Reports Interim Analysis of a Phase IIa Clinical Trial of Valopicitabine (NM283) in Combination With Pegylated Interferon in Treatment- Naive Hepatitis C Genotype 1 Patients
- Results of Phase IIa Study Show That Reverset Has Potential to Reduce HIV Viral Load in Treatment-Experienced Patients
 |
 |
User Comments (0)
RSS Feeds