Hemispherx BioPharma Inc (NYSEMKT:HEB) Making A Comeback

Hemispherx BioPharma Inc (NYSEMKT:HEB) is one biotech name that has desperately been in need of few changes. It looks like investors are going to get the turnaround needed after the company finally fired longtime Chairman & CEO Dr. William Carter. Dr. Carter had been fighting with the board and his subordinates over the direction of the company. We're glad he's out the door as it's been under his watch that significant shareholder value has been destroyed. It is now up to new CEO Thomas Equels and Chairman Dr. William Mitchell to execute the turnaround.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 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, including Chronic Fatigue Syndrome. Hemispherx’s platform technology includes components for potential treatment of various severely debilitating and life threatening diseases. Because both Ampligen and Alferon LDO are experimental in nature, they are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials.Hemispherx has patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection), approved for sale in the U.S. and Argentina. The FDA approval of Alferon N Injection is limited to the treatment of refractory or recurrent external genital warts in patients 18 years of age or older. The company’s Alferon N Injection approval in Argentina includes the use of Alferon N Injection (under the brand name "Naturaferon”) for use in any patients who fail, or become intolerant to recombinant interferon, including patients with chronic active hepatitis C infection. The company wholly owns and exclusively operates a GMP certified manufacturing facility in the United States for commercial products.Where HEB could see some speculative interest from investors relates to the Zika virus. Hemispherx is beginning to consider study designs for potential tests of the activity and potential uses of its natural alpha interferon (Alferon N and Alferon LDO) and rintatolimod (Ampligen) drug formulations against the Zika virus. The recent orphan drug designations of Ampligen for Ebola and Alferon N for MERS viruses by the European Regulatory authorities demonstrates the global need for drugs that possess broad antiviral activities against emerging viruses.Hemispherx's previous pre-clinical studies of Ampligen indicate that Ampligen has shown activity against member of the flavivirus family. Now HEB intends to pursue testing of Ampligen against Zika. Hemispherx scientists are exploring the hypothesis that intranasal (IN) use of Ampligen or oral use of Alferon in non-pregnant patients with active Zika viral infection could decrease viral load in blood and other body fluids, such as saliva and semen could shorten the time period during which the virus may be transmitted, and/or could decrease viral related tissue pathology. In addition, the symptomatic period may be shortened. This would be similar to the successful approach previously used for Tamiflu in treating early influenza infections.Many public health officials believe that the new cases of Zika virus are likely to surge in coming months in the Americas. To facilitate ease of treatment in potential new outbreaks of Zika infections, the company is considering an oral delivery route of Alferon N, e.g., Alferon LDO. Alferon LDO was previously authorized by the FDA for a prevention and treatment study protocol in influenza.The first order of business for the company needs to be following through and get some reputable pre-clinical testing done with Ampligen against Zika. The company also needs to get their CFS Phase III trial revamped, restarted, and populated to satisfy the FDA. If HEB can get sales of Alferon going, that would be another positive step. Making these moves will go a long way in establishing management's credibility and keep the stock heading higher. Overall, we do see potential with HEB and believe that with Dr. Carter gone, a turnaround is not only possible, but highly likely. We will be updating Insider Financial as soon as we know more. For continuing coverage on HEB and our other hot stock picks, sign up for our free newsletter today and get our next hot stock pick!Disclosure: We have no position in HEB and have not been compensated for this article.