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February 4, 2013
19:39 EDTHEBFDA declines to approve Hemispherx's Ampligen new drug application
Hemispherx Biopharma announced that it received a complete response letter from the US Food and Drug Administration declining to approve its new drug application for Ampligen for Chronic Fatigue Syndrome. The FDA said Hemispherx should conduct at least one additional clinical trial, complete various nonclinical studies and perform a number of data analyses. In its complete response letter, the FDA set forth the reasons for this action and provided recommendations to address certain of the outstanding issues. The agency stated that the submitted data do not provide substantial evidence of efficacy of Ampligen for the treatment of CFS and that the data do not provide sufficient information to determine whether the product is safe for use in CFS due to the limited size of the safety database and multiple discrepancies within the submitted data. Hemispherx plans to request an end-of-review conference with the FDA as a precursor to submitting a formal appeal to the office of new drugs in the FDA's center for drug evaluation and research regarding the agency's decision
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July 22, 2014
08:41 EDTHEBHemispherx achieves high ranking in sensitivity testing against MERS/SARS
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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.
July 8, 2014
08:43 EDTHEBHemispherx, Bioclones to collaborate on HIV/AIDS eradication
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