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Med Gen Inc. (OTCBB: MGEN)(January 22, 2008), manufacturers of nationally branded OTC healthier life products and specialty financial services, reports that it has signed a contract with Legacy Group to promote Fab U Lust via E-Mail and Internet advertising campaigns that will utilize an opt-in list of 17 million subscribers. The Internet portion will include Ad Words on Google, Yahoo, MSN, Excite and Ask, the five leading Internet search engines. All promotions will start February 1st and continue as results warrant.
Legacy Research Group and its affiliate companies are leaders in the field of e-mail and Internet promotions. The company cannot project returns; however, it is estimated that results from promotions of this kind can yield returns of 1%-2% or $200,000-$400,000.
Med Gen Inc., in business since 1996, manufactures and markets specialty products using its proprietary delivery system Spray's the Way ("STW"). It is best known for producing the world's first patented liquid spray snoring relief formula, Snorenz . Since its existence, Med Gen has continued to develop its STW technology, introducing Good Nights Sleep and the UnDiet system into its family of brands. Fab U Lust, the company's newest product, a female sexual stimulant, has been launched in test markets throughout the country. While STW technology is mainly used, the company also produces other products that deal with common health issues using other delivery systems. The company markets its products to distributors, major chain and drug stores, direct sales via the company web site and direct to consumer television, radio and print advertising. The company also distributes its brands internationally under various private labels or existing names. The Company also offers specialty services to small emerging public companies in similar fields as a way of adding assets to its base business.
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The Amacore Group, Inc., (OTC BB: ACGI)(January 22, 2008), a leader in providing health-related membership benefit programs, insurance programs, and other innovative and high-quality solutions to individuals and families across the country, announced earlier today that Vicis Capital Master Fund has further expanded its investment in The Amacore Group by purchasing additional shares of the Company's convertible preferred stock for $3.0 million, convertible at a peg price of $5. This follows a similar investment made in October.
Clark A. Marcus, CEO of The Amacore Group, said, "This infusion of capital is yet another vote of confidence in Amacore by Vicis. In the last few months, we have added additional distribution channels, provider networks, new products and acquired Texas-based LifeGuard Benefit Services, Inc., which provides insured and non-insured health benefits along with its services to over 1.5 million families."
He added, "Amacore's plans for 2008 are to continue with this growth both organically and by acquisition where appropriate. In 2007, we put the machinery in place for a breakthrough year in 2008. That breakthrough became visible in the last quarter of 2007, and we expect it to expand rapidly in 2008.
Shad Stastney, a partner of Vicis Capital, stated, "Amacore's growth is proceeding very rapidly, and we are very pleased with their progress. We are making this investment in the company to further demonstrate our commitment to their innovative and comprehensive approach to the healthcare marketplace.
With the additional capital provided Amacore can virtually expand at will and acquire opportunities that present themselves. America's healthcare system is broken, and Amacore is one of the few entities with a solution that is available right now, that doesn't need approval from Washington and that everyone can afford. We are extremely confident of great things from Amacore in 2008."
The Amacore Group, Inc. offers innovative and affordable healthcare solutions to families, individuals, small and large employer groups, and association markets through a wide array of unique products, benefits and services created for the consumer driven healthcare market. The Company also offers a unique and proprietary administrative system that supports call center management, agent distribution and affinity marketing for all levels of product delivery and reporting. Amacore has created several limited medical programs that include its new Diamond Series and Discount Medical programs, featuring Smarthealth Plus and Smarthealth Premier, which expand the Company's offerings beyond its very successful eye care program, Eye Care International (www.ecivisionplan.com). These new programs offer discounts on quality hearing, dental, vision and doctor visits, among other benefits. Amacore is aggressively signing distribution and sales contracts with marketing companies to offer these programs nationwide. Through its wholly-owned subsidiary, LifeGuard Benefit Solutions, Inc., Amacore now has the ability to provide administrative and back-office services to other healthcare companies in addition to expanding its own call center capability through its wholly-owned subsidiary, JRM Benefits Consultants, LLC.
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Earlier today Citing a significant advance in drug delivery, Vyteris, Inc. (OTC BB: VYHN) (January 22, 2008) and Ferring Pharmaceuticals announced results from a completed Phase 1 clinical trial demonstrating that Vyteris' patented Smart Patch transdermal technology successfully delivered a peptide molecule in humans (multiple pulse) without the use of needles (non invasively) in therapeutic levels aimed at the treatment of female infertility.
"These trial results represent a significant accomplishment for Vyteris in demonstrating that our delivery system are capable of achieving therapeutic levels of a peptide without using any needles," said Timothy J. McIntyre, chief executive officer of Vyteris. "This is the initial step in potentially clearing the pathway to pursue eventual commercialization of this technology and its broader applications to other peptides, which as a class of biotechnology drugs, are severely limited to delivery by subcutaneous (subQ) / intramuscular (IM) injections or intravenous (IV) infusions."
As part of the trial agreement between Vyteris and Ferring Pharmaceuticals, the study results showed that therapeutic levels of the peptide in humans are achievable without the use of injections or infusion pumps. The clinical trial was conducted in the U.S. with 30 healthy volunteers under an investigational new drug application (IND). Specific technical data will undergo peer review for future disclosure.
Kenneth Kashkin, Chief Medical Officer and Senior Vice President Global Clinical Research and Development of Ferring Pharmaceuticals, provided an assessment on the importance of this clinical advance: "Significant technological advances, not previously achieved in peptide delivery, have been accomplished by the Ferring/Vyteris team, and we look forward to successfully completing Phase I."
In the Phase I clinical trial, a pulse profile controlled the transdermal delivery of the peptide from patches loaded with different concentrations of the peptide. The amounts of peptide delivered using the patch were comparable or higher than with subcutaneous (subQ) injection. The study used different formulations within the Vyteris patch that were compared with subQ delivery of the peptide. No unexpected adverse side effects were observed in any of the trial participants.
The product under development by Vyteris and Ferring would employ Vyteris' patented Smart Patch drug delivery technology, which is positioned to provide a safe and effective method of delivering drugs via a pre-programmed regulating system, a characteristic important in the delivery of therapeutics for the treatment of female infertility while offering the possibility of administering the peptide without needles and is being designed to deliver multiple transdermal pulses automatically, around the clock, in a painless, convenient and cost-effective manner.
Ferring Pharmaceuticals is an international pharmaceutical company that manufactures and markets the largest family of fertility treatments of any manufacturer in the U.S. The Company markets BRAVELLE, MENOPUR, REPRONEX (menotropins for injection, USP), NOVAREL and ENDOMETRIN in the U.S. to infertility specialists and their patients. Ferring also offers the Q--CAP, the first and only needle-free reconstitution device, for use with its fertility treatments. Ferring's line of orthopaedic and urology products includes EUFLEXXA, hyaluronic acid for pain from osteoarthritis in the knee. Other products include ACTHREL (corticorelin ovine triflutate for injection) for the differential diagnosis of Cushing's syndrome and DESMOPRESSIN ACETATE in injectable and rhinal tube forms for the treatment of diabetes insipidus and primary nocturnal enuresis. The Ferring Group specializes in the research, development and commercialization of compounds in general and pediatric endocrinology, urology, gastroenterology, obstetrics/gynecology and infertility.
Vyteris, Inc is the maker of the first active drug delivery patch to receive marketing clearance from the U.S. Food and Drug Administration (FDA). Vyteris' proprietary active transdermal drug delivery (iontophoresis) technology delivers drugs comfortably through the skin using low-level electrical energy. This active patch technology allows precise dosing, giving physicians and patients control in the rate, dosage and pattern of drug delivery that can result in considerable therapeutic, economical, and lifestyle advantages over existing methods of drug administration. Vyteris' first product, LidoSite , which provides dermal analgesia prior to venipuncture (IV catheter insertions, blood draws, etc.) and superficial dermatological procedures, was the first FDA approved active patch.
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Aethlon Medical, Inc., (OTCBB: AEMD) (January 22, 2008) a pioneer in developing therapeutic devices for infectious disease, disclosed earlier today that researchers have demonstrated the effectiveness of the Aethlon Hemopurifier in capturing the highly-fatal H5N1 strain of the Avian Flu Virus (Bird Flu.) In pre-clinical studies, high concentrations of H5N1 flu virus (~ 3 million flu virus/ml) were observed to be rapidly depleted from cell culture fluids when circulated through the Hemopurifier . The study data indicated that during a six-hour testing period, the Hemopurifier removed up to 99.4 percent of infectious H5N1 flu virus. Verification of viral capture was documented by both real-time PCR and conventional plaque assay (TCID 50) measurements.
"The data provides real hope for a post-infection treatment against pandemic influenza and further reinforces the ability of our Hemopurifier to address a broad spectrum of viral conditions," stated James A. Joyce, Chairman and CEO of Aethlon Medical. "Additionally, it appears possible that the use of the Hemopurifier could open the door for drugs previously considered incapable of providing clinical benefit as a stand-alone therapy." The Aethlon Hemopurifier is a medical device designed for the single use removal of infectious viral pathogens from blood. The device, which augments the natural immune response of clearing infectious viruses and toxins before cell and organ infection, is positioned to fill a void in treating drug and vaccine resistant infectious diseases. In order to further support the use of the Hemopurifier as a broad-spectrum treatment countermeasure against bioterror and pandemic threats in the United States, Aethlon will include this new data in a forthcoming submission to the U.S. Department of Health and Human Services (HHS) and the newly established Biomedical Advanced Research and Development Authority (BARDA.) Based on the significance of the H5N1 data and the continued demonstration of safety in human studies, Aethlon may on a limited basis provide the Hemopurifier to countries that request the Hemopurifier as a treatment option for infected citizens. Researchers at the Battelle Biomedical Research Center conducted the H5N1 studies.
It is feared that the H5N1 strain of avian influenza virus, whose mortality rate in infected humans exceeds 60 percent, will spark a global epidemic should it evolve to allow for an efficient spread of host-to-host infections in humans. The recent discovery that H5N1 avian influenza virus can spread via the bloodstream to organs and other regions of the body typically not attacked by influenza viruses explains in part, the high virulence of H5N1 infection and why it remains a serious pandemic threat. The ability of H5N1 virus to proliferate in blood represents a causative effect for triggering hypercytokinemia (cytokine storm), a direct parallel to the Spanish Flu of 1918, which reportedly killed up to 40 million people within 20 months. Though governments and health agencies are stockpiling antiviral drugs to treat influenza, these therapies have yet to demonstrate effectiveness against human H5N1 infection. A further complication to drug treatment has arisen from the clinical observation that drug absorption appears impaired in severely ill H5N1 patients, and in H5N1 patients with gastrointestinal symptoms.
Researchers believe the removal of circulating H5N1 hemagglutinin, a surface protein that is deleterious to the host and immune system, combined with the removal of infectious H5N1 virus would be clinically beneficial to infected patients. Corresponding to this belief, the Hemopurifier targets the rapid removal of both infectious H5N1 virus and immunosuppressive H5N1 hamagglutinin from circulation. As a result, Aethlon believes the Hemopurifier is positioned to benefit infected patients, both as a stand-alone therapeutic, and as an adjunct treatment able to improve the clinical benefit of other candidate therapies.
Battelle Biomedical Research Center is a research group in the National Security Global Division of Battelle Memorial Institute, an organization that provides solutions to some of the world's most important challenges through its three global businesses: National Security, Energy Science and Technology, and Health and Life Sciences. Battelle is the world's largest independent research and development organization with technology contributions that find their way into hundreds of commercial products each year. Conducting multi-billion dollars in global R&D annually, Battelle oversees over 20,000 employees in more than 120 locations worldwide, including five national laboratories that Battelle manages or co-manages for the U.S. Department of Energy. Battelle was recently approved by the Department of Health and Human Services (HHS) under the Select Agent Programs of the Centers for Disease Control and Prevention (CDC) and the Animal and Plant Health Inspection Service (APHIS) to carry out studies on highly pathogenic avian influenza, including the H5N1 strain. Battelle was established in 1929 as a non-profit charitable trust and is headquartered in Columbus, Ohio.
Aethlon Medical is the developer of the Hemopurifier , a first-in-class medical device to treat infectious disease. The Hemopurifier addresses the largest opportunity in infectious disease, the treatment of drug and vaccine resistant viruses. The Hemopurifier is a single use extracorporeal device that converges hollow-fiber filtration technology with immobilized affinity agents to capture viruses and soluble glycoproteins from the blood. The device has been designed to mimic the natural immune response of clearing infectious viruses and immunosuppressive proteins from circulation. Regulatory and commercialization initiatives in the United States are focused on bioterror threats, while international initiatives are directed toward naturally evolving pandemic threats, and chronic infectious disease conditions including Hepatitis-C (HCV) and the Human Immunodeficiency Virus (HIV). Collaborative studies to demonstrate utility of the Hemopurifier are being conducted with researchers at the Government of India's National Institute of Virology (NIV), The Centers for Disease Control and Prevention (CDC), The United States Army Medical Research Institute of Infectious Diseases (USAMRIID), and The Southwest Foundation for Biomedical Research (SFBR). Aethlon recently demonstrated safety of the Hemopurifier in a 24-treatment human study and is now conducting follow-on safety studies at the Fortis Hospital in Delhi, India. The Company has also submitted an Investigational Device Exemption (IDE) to the U.S. Food and Drug Administration (FDA) related to advancing the Hemopurifier as a broad-spectrum treatment countermeasure against category "A" bioterror threats. Additional information regarding Aethlon Medical and its Hemopurifier technology can be accessed online at www.aethlonmedical.com.
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NanoViricides, Inc. (OTC BB: NNVC.OB) (the "Company")(January 22, 2008), reported earlier today that they are on course with the development of nanoviricides drug candidates against highly pathogenic avian influenzas (HPAI) including H5N1 bird flu, and common influenza. "We are now ready to begin animal studies on H5N1 at a renowned federal agency," said Dr. Eugene Seymour, MD, MPH, CEO of the Company. Earlier, the Company had delayed these studies in search of suitable facilities. The work is expected to begin once the contracts are finalized.
Bird Flu H5N1 continues to spread over ever-widening geographic regions and is a major cause of concern for potential pandemic influenza, according to the WHO. This year so far bird flu has spread into six districts in West Bengal, India, causing 120,000 birds to be culled in just 5 days, and 194,000 people to be screened for bird-flu-like symptoms, reports Times of India on January 21, 2008. A boy died of bird flu in Indonesia, and the H5N1 virus was found as far away as a Ukrainian village of Rivne and also northern part of Iran, reports Voice of America. Various research articles have appeared which make researchers fear the virus could mutate and become significantly transmissible between humans.
There are currently no effective treatments against H5N1, or the class of pandemic threatening viruses called HPAI. "The broad-spectrum FluCide, and the HPAI-specific FluCide-HP, are designed using the virus's host cell-binding features that do not change even when the virus mutates," says Anil R. Diwan, Ph.D., President of the Company. This feature would potentially make these two drugs the best current treatment options for development, says the Company. Vaccines and Antibodies could lose effectiveness due to mutations. H5N1 resistance to Tamiflu is well known, and resistance against other existing same-class (neuraminidase inhibitor) drugs such as peramivir and possibly Relenza could occur due to virus mutations.
Dr. Seymour has posted a summary of achievements of the Company on their website. Click here to download the NanoViricides, Inc. 2007 Calendar Year Summary.
NanoViricides, Inc. (www.nanoviricides.com) is a development stage company that is creating special purpose nanomaterials for viral therapy. The Company's novel nanoviricide class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. The Company is developing drugs against a number of viral diseases including H5N1 bird flu, seasonal influenza, HIV, hepatitis C, rabies, and dengue fever, among others.
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Earlier today GeNOsys (generated nitric oxide systems) Inc. (OTCBB: GNYS)(January 22, 2008) , a medical research and development company specializing in pharmaceutical, biotechnical and medical gas generating systems, announced the completion of the Company's Nitric Oxide Generator Portable Tablet.
According to a company spokesperson, IriSys successfully formulated the GeNOsys tablets into a product that could be manufactured in high quantities yet maintain the necessary tablet hardness, appropriate generated Nitric Oxide concentration and volume.
Further, the completion of the contract with IriSys Pharmaceuticals represents a major milestone in the process toward submitting the Company's portable Nitric Oxide Generator to the FDA. The work completed at IriSys was completed on time and under budget.
IriSys provides pharmaceutical product development contract services specializing in formulation development, cGMP manufacturing of clinical trial materials and consulting related to the drug development process. IriSys' custom approach to drug development is supported by its scientific and regulatory experience in moving over 100 drug products from discovery to Phase I, Phase II, Phase III and to commercialization.
Mr. Clark Mower, GeNOsys' Director, stated, "The completion of the IriSys contract on time and under budget depicts a tremendous success for the Company. We are moving rapidly toward a 510 (k) FDA approved device submission. Prior to submitting for an FDA approval, it was necessary to develop a manufacturing process that could be translated into large scale production while maintaining the product's quality requirements. We look forward to being able to customize the tablets for a specific disease, which represents a final step prior to FDA submission."
GeNOsys Inc. (generated nitric oxide systems) is a medical research and development company specializing in pharmaceutical, biotechnical and medical gas generating systems. Nitric oxide gas will be one of the medical gases that will be generated along with various combinations of beneficial medical gases suitable for the control of human disease. GeNOsys management believes it can reduce regulatory time through the use of strategic suppliers. Distribution will be accelerated through the use of already existing distribution networks that currently sell related respiratory products.
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Tuesday, January 22, 2008
(OTCBB: MGEN), (OTC BB: ACGI), (OTC BB: VYHN), (OTCBB: AEMD), (OTC BB: NNVC.OB), (OTCBB: GNYS)…..
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