Reuters Mon Nov 2, 2009 8:46am EST
PHILADELPHIA, Nov. 2, 2009 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE
Amex:HEB) (the "Company"), announced a two-prong CFS clinical mission for November and December 2009.
The Company plans to widen its ongoing clinical programs in CFS by accelerating collaborations with a consortium of researchers who have just discovered a retroviral link to Chronic Fatigue Syndrome (please see October 8, 2009, online issue of Science). A clinically validated test to detect retrovirus antibodies in patients plasma is also currently under development
(please see US National Institutes of Health at:
http://www.cancer.gov/newscenter/pressreleases/CFSxmrv). With the consortium of
researchers at the Whittemore Peterson Institute, the Company is also now evaluating the defect in immunosurveillance in specific subsets of CFS patients in a clinical study entitled "Therapeutic Activation of NK lymphocytes to Alleviate Chronic Fatigue Syndrome." These immune defects may be due to the previously undetected retrovirus.
The Company also plans to complete all outstanding queries from the FDA regarding its New Drug Application (NDA) for Ampligen(R), an experimental therapeutic, during November and December, 2009. On May 26, 2009, the Company announced a delay on the Ampligen NDA which, at the time, had a PDUFA date of May 25, 2009. As noted in the 10-Q and 10-K filings at the time, the FDA did not request additional information from the Company at that time.
However, several outstanding NDA items, requiring Hemispherx responses, existed at the time of the FDA delay as noted in the August 8, 2009, 10Q filing. Between March 9, 2009
and September 15, 2009, the Company issued six (6) new reports to the Agency spanning various subjects including a) clinical safety assessments, b) specialized pre-clinical toxicology reports, and c) abbreviated chemistry and manufacturing control reports. The Company believes that these reports may fully retire all Agency queries in these particular areas.
The Company also plans to submit four (4) additional reports on interrelated topics in November and December, 2009, which will include pharmacokinetic analyses in multiple lower animal species (primates, rodents, etc.) ("the Lovelace Laboratory Studies") and final validation reports of certain manufacturing procedures conducted at an independent facility, Hollister-Stier
Laboratories in Spokane, WA. Some of these reports were recently cited in
BioMedReports.com and the Science Business Exchange (October 15, 2009).
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(R) (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics Ampligen(R) Oragens(R), and Alferon LDO. Ampligen(R) and Oragens(R) represent experimental RNA nucleic acids being developed for globally important debilitating diseases and disorders
of the immune system. Hemispherx's platform technology includes large and small
agent components for potential treatment of various severely debilitating and
life threatening diseases. Hemispherx has in excess of 50 patents comprising its
core intellectual property estate and a fully commercialized product (Alferon N
Injection(R)). 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.
About Whittemore Peterson Institute
The Whittemore Peterson Institute for Neuro Immune Disease exists to bring
discovery, knowledge, and effective treatments to patients with illnesses that
are caused by acquired dysregulation of both the immune system and the nervous
system, often resulting in lifelong disease and disability. www.wpinstitute.org.
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(R), Alferon(R) LDO and Oragens(R)) 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.
Clinical trials for other potential indications of the approved biologic Alferon N Injection(R) do not imply that the product will ever be specifically approved commercially for these other treatment indications; Similarly, the completion of NDA filing process with Ampligen(R) does not imply that the product will ever be approved commercially.
-0-
CONTACT: Hemispherx Biopharma, Inc.
Dianne Will
518-398-6222
ir@hemispherx.net
PHILADELPHIA, Nov. 2, 2009 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE
Amex:HEB) (the "Company"), announced a two-prong CFS clinical mission for November and December 2009.
The Company plans to widen its ongoing clinical programs in CFS by accelerating collaborations with a consortium of researchers who have just discovered a retroviral link to Chronic Fatigue Syndrome (please see October 8, 2009, online issue of Science). A clinically validated test to detect retrovirus antibodies in patients plasma is also currently under development
(please see US National Institutes of Health at:
http://www.cancer.gov/newscenter/pressreleases/CFSxmrv). With the consortium of
researchers at the Whittemore Peterson Institute, the Company is also now evaluating the defect in immunosurveillance in specific subsets of CFS patients in a clinical study entitled "Therapeutic Activation of NK lymphocytes to Alleviate Chronic Fatigue Syndrome." These immune defects may be due to the previously undetected retrovirus.
The Company also plans to complete all outstanding queries from the FDA regarding its New Drug Application (NDA) for Ampligen(R), an experimental therapeutic, during November and December, 2009. On May 26, 2009, the Company announced a delay on the Ampligen NDA which, at the time, had a PDUFA date of May 25, 2009. As noted in the 10-Q and 10-K filings at the time, the FDA did not request additional information from the Company at that time.
However, several outstanding NDA items, requiring Hemispherx responses, existed at the time of the FDA delay as noted in the August 8, 2009, 10Q filing. Between March 9, 2009
and September 15, 2009, the Company issued six (6) new reports to the Agency spanning various subjects including a) clinical safety assessments, b) specialized pre-clinical toxicology reports, and c) abbreviated chemistry and manufacturing control reports. The Company believes that these reports may fully retire all Agency queries in these particular areas.
The Company also plans to submit four (4) additional reports on interrelated topics in November and December, 2009, which will include pharmacokinetic analyses in multiple lower animal species (primates, rodents, etc.) ("the Lovelace Laboratory Studies") and final validation reports of certain manufacturing procedures conducted at an independent facility, Hollister-Stier
Laboratories in Spokane, WA. Some of these reports were recently cited in
BioMedReports.com and the Science Business Exchange (October 15, 2009).
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(R) (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics Ampligen(R) Oragens(R), and Alferon LDO. Ampligen(R) and Oragens(R) represent experimental RNA nucleic acids being developed for globally important debilitating diseases and disorders
of the immune system. Hemispherx's platform technology includes large and small
agent components for potential treatment of various severely debilitating and
life threatening diseases. Hemispherx has in excess of 50 patents comprising its
core intellectual property estate and a fully commercialized product (Alferon N
Injection(R)). 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.
About Whittemore Peterson Institute
The Whittemore Peterson Institute for Neuro Immune Disease exists to bring
discovery, knowledge, and effective treatments to patients with illnesses that
are caused by acquired dysregulation of both the immune system and the nervous
system, often resulting in lifelong disease and disability. www.wpinstitute.org.
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(R), Alferon(R) LDO and Oragens(R)) 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.
Clinical trials for other potential indications of the approved biologic Alferon N Injection(R) do not imply that the product will ever be specifically approved commercially for these other treatment indications; Similarly, the completion of NDA filing process with Ampligen(R) does not imply that the product will ever be approved commercially.
-0-
CONTACT: Hemispherx Biopharma, Inc.
Dianne Will
518-398-6222
ir@hemispherx.net
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