|Drastically reduced our cash burn rate while aggressively opening new opportunities for Ampligen in the fast-growing field of immuno-oncology|
Moreover, we have tremendous confidence in our product portfolio. I believe Ampligen is the 'shape of things to come' in immunology. It is poised to potentially become an important therapy in the rapidly expanding field of immuno-oncology. It is the only activator of Toll-like Receptor 3 with a well-established safety record.Some of the key developments in our Ampligen program have included regulatory approval in one of South America's largest markets, a stepped-up collaboration to support a regulatory submission for ME/CFS in Canada, positive results from an intranasal safety study, and several new initiatives to leverage the immunotherapeutic properties of Ampligen in state-of-the-art cancer treatment strategies. Key Advancements For Ampligen
- Ampligen has been approved in Argentina for severely debilitated Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) patients and we are pursuing similar approvals in Chile and Peru. We are collaborating with Millions Missing Canada to bring Ampligen to Canadians suffering from ME/CFS. In addition, we are in continuing discussions with the FDA regarding our New Drug Application in ME/CFS. Ampligen is the only drug to have completed a Phase 3 clinical trial in the U.S. in ME/CFS, a condition which according to the Center for Disease Control (CDC) afflicts more than one million people in this country. Taking into account that trial's results, and the FDA's indication at our last meeting that they would be open and receptive to review a proposal by the Sponsor (Hemispherx), we plan to seek approval tied to a protocol we are developing for conducting a study, limiting enrollment to patients with high responder potential.
- Earlier this year we began supplying Ampligen for pancreatic cancer patients in an Early Access Program (EAP) in the Netherlands managed by myTomorrows, an international leader in providing physicians with early access to experimental drugs.
- Significant research at the University of Pittsburgh and Roswell Park Cancer Center is underway to determine the extent to which Ampligen alone and in combination with other agents may prime the tumor microenvironment in ways that could improve the lethality of cancer-killing T cells in conjunction with PD-1 and PD-L1 checkpoint inhibitors, such as Keytruda from Merck and Opdivo from Bristol-Myers Squibb. The success of these studies and others being planned could lead to a significant advance in the fast-growing field of immuno-oncology.
- Attracting a greater number of antigen-specific cytotoxic T cells into the tumor microenvironment while increasing their ratio to immunosuppressive Treg cells is expected to significantly improve the overall effectiveness of checkpoint inhibitors, a new class of drugs designed to destroy the blocking mechanisms that prevent effector cytotoxic T cells from attacking tumor cells. The use of checkpoint inhibitors is growing rapidly (Cowan & Co. projects sales to grow to $30 billion annually by 2020) and we are developing Ampligen with the anticipation of it becoming an integral part of combinational therapies tapping into that growth.
- We recently commenced full data analysis of an intranasal vaccine study of Ampligen plus FluMist. Intranasal Ampligen was generally well-tolerated in this study. Numerous studies have shown that Ampligen is a generally well-tolerated and highly selective Toll-like Receptor 3 agonist capable of inducing the innate immune responses needed for adaptive protective immunity. Monkeys immunized with H5N1 vaccine and Ampligen showed enhanced protection against a highly pathogenic H5N1 virus. Mouse models showed Ampligen generates cross-protection against 3 clades of highly pathogenic H5N1 using a seasonal vaccine. The human intranasal safety study demonstrated antibodies against viral strains not present in the immunizing vaccine. Highly pathogenic bird strains of influenza remain a clear and present human danger for a devastating influenza pandemic. Only one or two mutations in the viral attachment receptor of these highly pathogenic bird influenza viruses are required to provide an easily spread and highly lethal virus in humans. The clinical data from our FluMist study extends the mouse and monkey studies. The experimental data suggests that intranasal immunization with Ampligen may provide a rapid and well tolerated means of protection in at-risk humans. We are currently exploring co-development partnerships with vaccine producers.
We have finalized a commercial-scale "fill and finish" production agreement to fulfill our forecasts for Ampligen demand in 2018. New inventory is planned to be available 2Q18 for Argentina, for US based clinical studies and for Early Access Program sales in Europe.
|New Jersey manufacturing facility - completed work to resume production and awaiting funding and FDA re-certification|
I look forward to keeping you updated on our progress./s/Thomas K. Equels Chief Executive Officer About Hemispherx Biopharma, Inc. Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx's flagship products include Alferon N Injection® and the experimental therapeutic rintatolimod (tradenames Ampligen® or Rintamod®). Rintatolimod is an experimental RNA nucleic acid being developed for globally important debilitating diseases and disorders of the immune system, including Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). Hemispherx's platform technology includes components for potential treatment of various severely debilitating and life threatening diseases. Because rintatolimod is experimental in nature, it is not designated safe and effective by the FDA for general use and is legally available only through clinical trials. Cautionary StatementSome of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.hemispherx.net. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only. Contact Phone Number: 800-778-4042 Email: IR@hemispherx.net