Incidence of NABs Induced Against Natural IFNs, Such as Alferon N Injection®, Was Very Low (<0.2%) and Significantly Less Than for Recombinant IFNs
PHILADELPHIA, March 26, 2012 (GLOBE NEWSWIRE) -- Hemispherx Biopharma Inc. (NYSE Amex:HEB) announced the publication of a peer-reviewed article in the Journal of Interferon and Cytokine Research (Volume 32, pages 95-102) providing an analysis of the incidence and clinical impact of neutralizing antibodies (NABs) formed during treatment with recombinant interferons (α-2a, α-2b, β-1a and β-1b) compared to natural interferons (α-n1 or α-n3), such as Alferon N Injection®. The recombinant interferons induced seroconversion with the generation of NABs in 17.2% of patients studied. Seroconversion is the development of detectable specific antibodies. Antibodies can sometimes attack a pharmaceutical administered to the body eventually inhibiting the effect of the medication.
In contrast the incidence of antibodies induced against natural interferons was very low, less than 0.2%, and was significantly less than that seen for recombinant interferons (p<0.0001). The fraction of relapsed (responded initially) and refractory (resistant to treatment) patients was greater in NAB positive patients compared to NAB negative patients (p<0.0001).
The percentage of patients who responded to treatment was also higher in the NAB negative group (p<0.0011). Overall, in 82% of the NAB positive patients treated with recombinant interferons, switching to natural interferons restored the clinical response, indicating that the NABs directed against recombinant interferons, do not effectively cross-react with natural interferons. Therefore, the presence of NABs produced against a recombinant interferon does not appear to interfere with the effectiveness of natural interferons.
Alferon N Injection® is the registered trademark for Hemispherx's injectable formulation of natural interferon, which is approved by the FDA for the treatment of certain categories of genital warts. According to the Centers for Disease Control and Prevention (CDC), "Approximately 20 million Americans are currently infected with Human papillomavirus (HPV) with another 6 million people becoming newly infected each year. HPV is so common that at least 50% of sexually active men and women get it at some point in their lives. About 1% of sexually active adults in the U.S. have genital warts at any one time. Although treatments exist that can remove the warts, they do not remove the HPV, and so warts can recur after treatment (about 50–73% of the time)." Alferon N Injection® is the only natural-source, multispecies α-interferon currently approved for sale in the United States for the intralesional treatment of refractory or recurring external genital warts in patients 18 years or older.
As reported recently, Alferon N Injection® (under the brand name "Naturaferon") has been approved for sale and distribution in Argentina. The receipt of the ANMAT (Administracion Nacional de Medicamentos) approval is the first step of a regulatory process towards commercial sales of Naturaferon.
In addition Hemispherx is developing an experimental low-dose, oral liquid formulation of Natural Alpha Interferon, Alferon® LDO [Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived)] and like Alferon N Injection®, should not cause antibody formation. Alferon® LDO is an experimental immunotherapeutic believed to work by stimulating an immune cascade response in the cells of the mouth and throat, enabling it to bolster systemic immune response through the entire body by absorption through the oral mucosa. Oral interferon could be economically feasible for patients and logistically manageable in development programs in third-world countries primarily affected by influenza and other emerging viruses. Oral administration of Alferon® LDO, with its anticipated affordability, low toxicity, no production of antibodies, and broad range of potential bioactivity, could be a breakthrough treatment or prevention for viral diseases.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx's flagship products include Alferon N Injection® (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics Ampligen® and Alferon® LDO. Ampligen® is an experimental RNA nucleic acid being developed for globally important debilitating diseases and disorders of the immune system. Hemispherx's platform technology includes components for potential treatment of various severely debilitating and life threatening diseases. Hemispherx has patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection®). The Company wholly owns and exclusively operates a GMP certified manufacturing facility in the United States for commercial products. For more information please visit www.hemispherx.net.
Information contained in this news release, other than historical information, should be considered forward-looking and is subject to various risk factors and uncertainties. For instance, the strategies and operations of Hemispherx involve risk of competition, changing market conditions, change in laws and regulations affecting these industries and numerous other factors discussed in this release and in the Company's filings with the Securities and Exchange Commission. Any specifically referenced investigational drugs and associated technologies of the Company (including Ampligen® and Alferon® LDO) are experimental in nature and as such are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials with the referenced disorders. The forward-looking statements represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements. The planning, completion, results or submission of clinical trials do not imply that any study product will ever be approved commercially for the studied or other treatment indications.