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News Breaks
July 14, 2014
08:39 EDTHEBHemispherx, Bioclones announce strategic alliance
Hemispherx Biopharma announced a strategic alliance to develop multiple projects with Bioclones. Bioclones and Hemispherx concluded strategic discussions in Johannesburg with three principal goals; initiating studies utilizing Ampligen as a potential adjuvant enhancement of Bioclones' therapeutic cancer vaccine, currently in clinical trials in Cape Town, including pre-clinical studies followed, potentially, by a Phase 1 clinical trial; seeking South African Medicine's Control Council approval to conduct trials using Alferon to eradicate the HIV virus in patients highly responsive to anti-retroviral therapy; and initiating a joint effort to obtain commercial registration of both Ampligen and Alferon in the South African markets. The first clinical program builds on the Bioclones patented therapeutic human dendritic cell, or DC, cancer vaccination approach. This invention provides a method of producing mature DCs in vitro, which comprises the step of culturing the immature DCs, thereafter exposing said cells to tumor antigens before administration to patients. The team has successfully obtained the necessary Ethics approval to use Ampligen as an adjuvant in the Bioclones pre-clinical cancer immunotherapy program utilizing patient derived samples. Pre-clinical studies will be directed towards the potential treatment of breast cancer in particular, followed by prostate cancer. These studies are part of the effort to develop patient-specific DC immunotherapy vaccines against breast cancer and prostate cancer, which elicit an immune response that will target and kill cancer cells. Human DCs matured with Ampligen and transfected with autologous tumor-specific mRNA are designed to elicit a potent and autologous tumoricidal antigen-specific cytotoxic response to the cancer.
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March 24, 2015
08:35 EDTHEBHemispherx receives positive opinion on application for Orphan designation
Hemispherx Biopharma announces that the European subsidiary, "Hemispherx Biopharma Europe N.V./S.A" gained a positive opinion from the COMP (Committee on Medical Products) regarding its Orphan Medicinal Product Application for Ampligen, an experimental therapeutic, to treat Ebola Virus Disease, or EVD. The dossier submitted to the EU contained an inventory of relevant pre-clinical research in EVD therapeutically-oriented models, as well as, clinical safety information derived from non-EVD clinical studies of Ampligen. Of potentially high relevance to the favorable COMP opinion were experiments, conducted in Italy, which showed that, in vitro, Ampligen successfully competed with Ebola viral dsRNA in a manner which may result in loss of virulence by EBOV.
March 19, 2015
07:14 EDTHEBWall Street Analyst Forum to hold a conference
25th Annual Investor Conference is being held in New York on March 19.

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