Hemispherx
Biopharma, HEB, Profile, Summary
Hemispherx
Biopharma, HEB,
is a biopharmaceutical company dedicated to treating and preventing
chronic viral and immune-based disorders through the development and
manufacturing of compounds that enhance the natural immune system of
the human body. Hemispherx Biopharma, has developed over nearly
three decades a vast body of knowledge relating to a potentially new
class of pharmaceutical products (nucleic acid compounds) that are
designed to activate otherwise dormant cellular defenses against
viruses and tumors.
The
Company’s flagship products include Alferon N Injection® and the
experimental immunotherapeutics Ampligen®. Its platform technology
includes large and small agents for potential treatment of various
chronic viral infections.
Ampligen®, is a new
class of specifically-configured ribonucleic acid (RNA) compounds
targeted at such important diseases as Chronic
Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME), HIV,
Hepatitis
B, Hepatitis
C, and cancers including kidney
cancer and metastatic
malignant melanoma.Alferon N Injection® (interferon alfa-n3, human leukocyte derived) is a highly purified, natural source, glycosylated, multi-species alpha interferon product, composed of eight forms of high-purified alpha interferon. It is the only natural source, multi-species alfa interferon currently sold in the United States and is also approved for sale Argentina. Alferon N Injection® is the company’s registered trademark for it’s injectible formulation or natural alpha interferon approved by the FDA for the treatment of genital HPV (refractory condylomata acuminata). Alferon N Injection® may also have activity against other viral infections such as Multiple Sclerosis, Hepatitis C, HIV, West Nile Virus, and SARS, but has not been approved for that use.
Ampligen®
Ampligen®,
the company's lead compound addresses a variety of chronic diseases
and viral disorders. Ampligen® drugs for several viral disorders are
under development. More than 40,000 doses at over 20 U.S. clinical
trial sites have been delivered with Ampligen®.
ALFERON N Injection®
ALFERON N Injection® [Interferon alfa-n3 (human leukocyte derived)] is the Company's registered trademark for its injectable formulation of Natural Alpha Interferon, approved by the U.S. Food and Drug Administration (FDA) for the intralesional treatment of refractory or recurring external condylomata acuminata in patients 18 years of age or older.ALFERON N Injection® is the only highly purified, natural-source, multispecies alpha interferon product currently sold in the U.S. and is also approved for sale in Argentina.
Clinically Effective:
- All warts disappeared in 54% of patients.3
- No recurrence in 76% of complete responders at follow-up.3
- Completely cleared 73% of all treated warts.3,4
- No human antibodies to interferon alfa-n3 detected in clinical trails.3,4
- Provides a spectrum of multiple
alpha interferon subtypes.1,2
- No surgery or caustics and resultant ulceration or scarring.
- No specific post-treatment care necessary.4
- The most common adverse effects (mild to moderate, transient flu-like symptoms) were comparable to placebo after 304 weeks of therapy.3.4
- The majority of patients
considered Alferon N Injection preferable to conventional therapy.
3.4
Alferon Low Dose Oral (LDO)®
Alferon LDO®, Hemispherx's oral form of Our Anferon N product (Low Dose Oral Interferon Alfa-N3, Human Leukocyte Derived), which is a new delivery form of our FDA approved drug, Alferon N® is the only natural interferon currently FDA approved and available in the marketplace. Hemispherx has initiated clinical trials as part of an accelerated evaluation of the experimental bio-therapeutic Alferon LDO (Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived)) as a potential new experimental therapy for Avian Flu and other lethal viral diseases, which have high acute death rates. Clinical trials in human volunteers (being conducted in both the U.S. at Drexel University, Philadelphia, and shortly to commence in Hong Kong at the Princess Margaret Hospital) are designed to determine whether Alferon N, delivered in a new, experimental oral drug delivery format, can resuscitate the broad-spectrum antiviral and immunostimulatory genes. These human genes are shut down by acute lethal viral infections such as avian flu and smallpox
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HPV,
HIV, Chronic Fatigue Syndrome (CFS), Hepatitis, influenza, H5N1,
H7N9, avian influenza, drug resistant avian influenza, Hepatitis A,
viral, bacterial, viral
infections, Multiple Sclerosis, Hepatitis C, West Nile Virus, SARS,
FDA. CIDC.
