From a friend - is this pump? HEMISPHERX BIOPHARMA: (HEB) $3.39 Up $.46 and traded on the Nasdaq Stock Exchange..... Here’s a play on the avian flu virus and one of our best institutional sources is telling us to expect positive developments. On Wednesday, the stock traded 5.3 million shares or 10 times its average daily volume. HEB also closed at a new 52-week high. We believe the stock is an easy double from current price levels. This is probably a conservative estimate as our technical analysis says the stock is headed to the $8.00 level. On the 5 year chart, HEB has traded as high as the high-teens.
In short, this appears to be a terrific play on the avian flu virus. The long version is that Hemispherex Biopharmathe is a biopharmaceutical company that manufactures and develops new drugs for the treatment of viral and immune based chronic disorders. The company was founded as a contract researcher for the National Institutes of Health. After almost 30 years, it has established a strong foundation of laboratory, pre-clinical, and clinical data with respect to the development of nucleic acids to enhance the natural antiviral defense system of the human body and to aid the development of therapeutic products for the treatment of chronic diseases. Hemispherx owns a manufacturing facility in New Jersey, and has corporate offices in Philadelphia. The company's flagship products include Ampligen and Alferon. Ampligen is an experimental drug undergoing clinical trials for the treatment of: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), HIV, and HIV/Hepatitis C co-infection. Ampligen is administered intravenously. In August 2004, Hemispherx completed a Phase III clinical trial treating over 230 ME/CFS patients with Ampligen and is in the process of preparing a new drug application to be filed with the FDA. Over 500 patients have received Ampligen in clinical trials authorized by the FDA at over 20 clinical trial sites across the U.S., representing the administration of more than 45,000 doses of this drug. Further studies are planned in cancer treatment but initiation dates have not been set. Alferon N Injection is the registered trademark for the company's injectable formulation of Natural Alpha Interferon, which is approved by the U.S. FDA for the treatment of genital warts. Alferon N is also in clinical development for treating Hepatitis C, Multiple Sclerosis, Human Immunodeficiency Virus (HIV), West Nile Virus and Severe Acute Respiratory Syndrome (SARS). The ALFERON N Injection product contains a multi-species form of alpha interferon. ALFERON LDO is an experimental low-dose, oral liquid formulation of Natural Alpha Interferon. It is an experimental immunotherapeutic believed to work by stimulating an immune cascade response in the cells of the mouth and throat, enabling it to bolster an immune response through the entire body orally. Oral interferon would be much more economically feasible for patients and logistically manageable in development programs in third-world countries primarily affected by HIV and other emerging viruses (SARS, Ebola, bird flu, etc.). Hemispherx has over 170 patents worldwide with 14 additional patents pending, which comprises its core intellectual property.
The company announced today that it had extended a preclinical report conducted by research affiliates of the National Institutes of Health at Utah State University to examine potential therapeutic synergies with more than 10 different drug combinations. The ongoing research is comparing the relative protection conveyed by Tamiflu (oseltamivir, Roche) and Ampligen® (dsRNA, Hemispherx), alone and in combination, against the avian flu virus (H5N1). True therapeutic synergy is defined by mathematical equations which indicate that the therapeutic effect observed is in fact greater than the expected arithmetic sum of the two drugs working independently, and is referred to by pharmacologists as the "Chou/Talalay" equations developed at Johns Hopkins University. True therapeutic synergy has now been observed in the interaction between Ampligen® and Tamiflu in the inhibition of the Avian influenza virus. Hemispherx recently reported new data on preclinical studies on double-stranded RNA (dsRNA), including Ampligen®, one of its flagship experimental immunomodulators. These studies suggest a new, and potentially pivotal, role of dsRNA therapeutics in improving the efficacy of the present standards of care in both influenza prevention and treatment of acute disease. The studies are attracting growing attention with the persistence of H5N1 avian influenza viruses in many Asian countries and their ability to cause fatal infections in humans. Concerns throughout the Region have risen with the discovery of a Tamiflu resistant strain of the virus. NATURE (14 October 2005), a respected science journal, reported that on February 27, 2005 an H5N1 influenza virus, A/Hanoi/30408/2005, was isolated from a 14 year old Vietnamese girl (patient 1) who had received a prophylactic dose of Tamiflu (oseltamivir). Although further investigation is needed, analysis of the isolated virus revealed two disturbing possibilities; that the virus could have been transmitted to the girl from her brother and that the virus was developing a resistance to Tamiflu. Although the findings were based on a single patient, the authors, in their conclusion, recommend the stockpiling of alternatives to Tamiflu. Hemispherx's Ampligen® is emerging as one of the more promising experimental alternatives.
In antimicrobial (antibacterial) therapy, which is the best studied clinical model, synergistic drug combinations may result in curative conditions/outcomes, often not observed when the single drugs are given alone. In the case of avian influenza where global drug supplies are presumptively in very limited supply relative to potential needs, therapeutic synergistic combinations could not only affect the disease outcome, but also the number of individuals able to access therapies. Cell destruction was measured in vitro using different drug combinations. At present, a narrow window of opportunity (approximately 48 hours) exists for effective utilization of Tamiflu after exposure to influenza. By providing a new mechanism of inhibition of avian flu, (i.e. immunologic/host defensive immune cascades), Ampligen®, an experimental immunotherapeutic, may also afford a new time interval to help combat the influenza virus. Recently, double-stranded RNA (dsRNA), such as Ampligen®, are also specific inducers of broad-spectrum antiviral/immune response. As noted in the Company's announcement of September 6, 2005, Japanese researchers have also found that dsRNAs increase the effectiveness of influenza vaccine by more than 300% and may also convey "cross-protection ability against variant viruses" (mutated strains of influenza virus). Hemispherx Biopharma recently disclosed they entered into a collaboration with HollisterStier Laboratories of Spokane, Washington, for the contract manufacturing of Hemispherx's experimental drug, Ampligen®. The achievement of the initial objectives, in combination with the Polymer production facility under construction in New Brunswick, N.J., will enable Hemispherx to significantly increase production capacity. Ampligen® also recently completed Phase III testing in the chronic disease, Chronic Fatigue Syndrome (CFS).
We have all heard news on a daily basis concerning a potential crisis with potentially millions of people dying of bird flu. As bird flu is spread continent-to-continent by wild birds, the seasonal migration that is one of nature's wonders is becoming something scary. Could bird flu reach North America through migrating birds? Biologists in Alaska and Canada are keeping an eye out and say it's possible by next year. Scientists from several agencies have been monitoring large flocks in the northern part of this continent since last summer, collecting live birds and thousands of samples from bird droppings. The results of those tests are pending, but scientists have not found the virus that is spreading across Asia. Of course, the bigger fear is that bird flu will mutate into a flu that is contagious and deadly to people and which would quickly spread around the globe through international travel. The bird flu is not easily spread to people. But scientists are studying the virus' transmission among birds as well. In the United States, a consortium of government agencies is seeking $5 million over the next three years to test birds along their migratory routes in the Lower 48 states beginning next spring.
"The patterns (of the virus) in Asia right now would not suggest that it would come over to North America this fall," said Christopher Brand, chief of field and lab research for the U.S. Geological Survey's National Wildlife Health Center in Madison, Wis. Here's why: Bird flu was observed spreading from domestic poultry to wild birds in Asia last summer in northern breeding grounds in Siberia. Most of those birds are migrating south -- along their distinctive routes called flyways -- to India and Bangladesh; others follow southwestern routes to the eastern Mediterranean and even Africa. Bird flu has been detected in wild and domestic birds as far east as the Danube Delta in Romania. The virus was reported in poultry in Turkey, Romania and Russia. "There has been a shift in the susceptibility of wild fowl to H5N1," acknowledged David Nabarro, chief U.N. coordinator for avian and human influenza. Brand says if those birds maintain the virus over the winter, they would have the opportunity to bring it back to northern nesting grounds in Siberia next spring and summer. While most Siberian flocks don't try to cross the Pacific to North America, some do cross the narrow Bering Strait to Alaska. If those birds mingle with birds from Alaska, "there is the possibility the virus could be transmitted to waterfowl or shorebirds that make their way here next fall," Brand said.
BOTTOM LINE: We have what appears to be an excellent play on the bird flu. We have a stock setting new 52-week highs. Today’s close was a new 52-week high on more than 5.3 million shares or 10 times the norm. Technical analysis is bullish, indicating a price objective of $8.00. One of our best institutional sources tells us that positive developments are brewing. |
