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Hemispherx BioPharma (HEB)

WILLIAM CARTER – HEMISPHERX BIOPHARMA INC 

R. WILLIAM CARTER has served as Chief Scientific Officer of Hemispherx Biopharma, Inc., since May 1989, the Chairman of the company's Board of Directors since January 1992, the company's Chief Executive Officer since July 1993, the company's President since April 1995, and a Director since 1987. He is the co-inventor of Ampligen', joined the company in 1978, and from 1987 to 1988, he served as the company's Chairman. Dr. Carter was a leading innovator in the development of human interferon for a variety of treatment indications including various viral diseases and cancer. In this context, he received the first FDA approval to initiate clinical trials on a beta interferon product manufactured in the US under his supervision. From 1985 to October 1988, Dr. Carter served as the company's Chief Executive Officer and Chief Scientist. He received his MD degree from Duke University and underwent his post-doctoral training at the National Institutes of Health and Johns Hopkins University. Dr. Carter also served as Professor of Neoplastic Diseases at Hahnemann Medical University, a position he held from 1980 to 1998. He also served as Director of Clinical Research for Hahnemann Medical University's Institute for Cancer and Blood Diseases, and as a Professor at Johns Hopkins School of Medicine and the State University of New York at Buffalo. He is a Board certified physician and author of more than 200 scientific articles, including the editing of various textbooks on anti-viral and immune therapy
 

Product Candidates

Our primary pharmaceutical product platform consists of our experimental compound, Ampligen®, our FDA approved natural interferon product, Alferon N Injection®, and our experimental liquid natural interferon for oral administration, Alferon® LDO (Low Dose Oral).

Ampligen® 
Ampligen® is an experimental drug currently undergoing clinical development for the treatment of Chronic Fatigue Syndrome (CFS). The FDA has so far declined to approve our NDA for the treatment of CFS with Ampligen® and has requested that we generate additional clinical data. Over its developmental history, Ampligen® has received various designations, including Orphan Drug Product Designation (FDA), Treatment protocol (e.g., “Expanded Access” or “Compassionate” use authorization) with Cost Recovery Authorization (FDA) and “promising” clinical outcome recognition based on the evaluation of certain summary clinical reports (“AHRQ” or Agency for Healthcare Research and Quality). Ampligen® represents the first drug in the class of large (macromolecular) RNA (nucleic acid) molecules to apply for NDA review. Based on the results of published, peer reviewed pre-clinical studies and clinical trials, we believe that Ampligen® may have broad-spectrum anti-viral and anti-cancer properties.

Alferon N Injection® 
Alferon N Injection® is the registered trademark for our injectable formulation of natural alpha interferon, which was approved by the FDA in 1989 for the treatment of certain categories of genital warts. Alferon® is the only natural-source, multi-species alpha interferon currently approved for sale in the U.S. for the intralesional (within lesions) treatment of refractory (resistant to other treatment) or recurring external genital warts in patients 18 years of age or older. Certain types of human papilloma viruses (“HPV”) cause genital warts, a sexually transmitted disease (“STD”). The U.S. Centers for Disease Control and Prevention (“CDC”) estimates that “approximately twenty million Americans are currently infected with HPV with another six million becoming newly infected each year. HPV is so common that at least 50% of sexually active men and women get it at some point in their lives.” Although they do not usually result in death, genital warts commonly recur, causing significant morbidity and entail substantial health care costs.

Interferons are a group of proteins produced and secreted by cells to combat diseases. Researchers have identified four major classes of human interferon: alpha, beta, gamma and omega. Alferon N Injection® contains a multi-species form of alpha interferon. The world-wide market for injectable alpha interferon-based products has experienced rapid growth and various alpha interferon injectable products are approved for many major medical uses worldwide. Alpha interferons are manufactured commercially in three ways: by genetic engineering, by cell culture, and from human white blood cells. All three of these types of alpha interferon are or were approved for commercial sale in the U.S. Our natural alpha interferon is produced from human white blood cells.

The potential advantages of natural alpha interferon over recombinant (synthetic) interferon produced and marketed by other pharmaceutical firms may be based upon their respective molecular compositions. Natural alpha interferon is composed of a family of proteins containing many molecular species of interferon. In contrast, commercial recombinant alpha interferon products each contain only a single species. Researchers have reported that the various species of interferons may have differing antiviral activity depending upon the type of virus. Natural alpha interferon presents a broad complement of species, which we believe may account for its higher activity in laboratory studies. Natural alpha interferon is also glycosylated (partially covered with sugar molecules). Such glycosylation is not present on the currently U.S. marketed recombinant alpha interferons. We believe that the absence of glycosylation may be, in part, responsible for the production of interferon-neutralizing antibodies seen in patients treated with recombinant alpha interferon. Although cell culture-derived interferon is also composed of multiple glycosylated alpha interferon species, the types and relative quantity of these species are different from our natural alpha interferon. 
Alferon N Injection® [Interferon alfa-n3 (human leukocyte derived)] is a highly purified, natural-source, glycosylated, multi-species alpha interferon product. There are essentially no neutralizing antibodies observed against Alferon N Injection® to date and the product has a relatively low side-effect profile. The recombinant DNA derived alpha interferon formulations have been reported to have decreased effectiveness after one year, probably due to neutralizing antibody formation.

Alferon® LDO (Low Dose Oral) 
Alferon® LDO [Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived)] is an experimental low-dose, oral liquid formulation of Natural Alpha Interferon and like Alferon N Injection®, should not cause antibody formation, which is a problem with recombinant 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 systemic immune response through the entire body by absorption through the oral mucosa. Oral interferon could be economically feasible for patients and logistically manageable globally for development programs for prevention and, or treatment of pandemic influenza, seasonal influenza and other emerging viruses. Oral administration of Alferon® LDO, with its anticipated affordability, low toxicity, no production of antibodies, and broad range of potential bioactivity, could be a breakthrough treatment or preventative for viral diseases.

 (NYSE MKTHEB) is a biopharmaceutical company based in PhiladelphiaPennsylvania.[1] Founded in 1990, the company has 32 employees.[2]

The company has created an immunomodulatory double stranded RNA drug called Ampligen.[3] The company is developing Ampligen to use as a treatment for chronic fatigue syndrome.[4]

On April 3, 2001, Hemispherx Biopharma, Inc. adjusted and restated its 1999 financial statements to reflect charges relating to an extension of the exercise period to certain warrants as of February 1999.

On April 3, 2006, Hemispherx Biopharma, Inc. restated financial results for 2003 and 2004 due to accounting mistakes related to debentures and warrants issued between March 2003 and August 2005

 

 

 




 


 

PIPELINE.

Commercial Products

Country:  USA
PRODUCT NAME   CATEGORY   COMMERICAL STATUS
     
Alferon N Injection®   Genital HPV (condylomata acuminata)   Sales anticipated to resume upon successful pre-approval inspection and supplemental approval by FDA
 
Country:  Argentina
PRODUCT NAME   CATEGORY   COMMERICAL STATUS
     
Alferon N Injection®   Genital HPV (condylomata acuminata)   Approved. Launch pending manufacturing approval
     
Alferon N Injection®   Refractory to Recombinant IFN   Approved. Launch pending manufacturing approval
     
Rintatolimod (U.S. Tradename: Ampligen®)   Severe Cases of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)   Approved. Launch pending
 
Product Candidate   Country   Indication
Ampligen®   USA   CFS/ME
     
Ampligen®   USA   HIV
     
Ampligen®   USA   Metastatic Melanoma
     
Ampligen®   USA   Renal Cell Carcinoma
     
Ampligen®   European Union   Ebola Virus Disease
     
Alferon N Injection®   European Union   MERS
 
 

 





 

 

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HEB News: Hemispherx Enters into Sale/Leaseback Agreement for NJ Development and Production Facility 01/17/2018 08:30:00 AM
HEB News: Current Report Filing (8-k) 01/12/2018 04:31:42 PM
HEB News: Hemispherx Enhances Manufacturing Efficiency of Ampligen 01/11/2018 08:30:00 AM
HEB News: Hemispherx Announces Presentation of New-Found Properties of Ampligen at Immuno-Oncology Frontiers Conference, Jan 24 01/09/2018 08:30:00 AM
HEB News: Amended Statement of Ownership (sc 13g/a) 01/05/2018 04:50:51 PM
PostSubject
#15069   https://stocknewsjournal.com/2018/01/17/digging-up-the-facts-on-hemispherx-bioph jimbosskow 01/21/18 08:38:51 AM
#15068   nibbling at these prices but there is so my name is 01/19/18 07:37:06 PM
#15067   https://www.gurufocus.com/news/626617/heres-why-the-2-latest-hemispherx-biopharm jimbosskow 01/19/18 07:10:59 PM
#15066   Source? jimbosskow 01/19/18 05:34:52 PM
#15065   That’s an impressive list! momoney163 01/19/18 09:09:52 AM
#15064   Word of the day, buyout. Just heard. Little ??;-) momoney163 01/18/18 11:29:05 PM
#15062   .53 my name is 01/18/18 03:57:25 PM
#15061   Q; Are there or can there be pump momoney163 01/17/18 11:41:13 PM
#15060   Always in the same way Jumpinjackas 01/17/18 07:24:11 PM
#15059   ouch here comes the pain my name is 01/17/18 05:09:56 PM
#15058   still holding and may buy on weakness my name is 01/17/18 09:22:03 AM
#15057   This could have a lot more to go. JBowsNose 01/17/18 08:47:12 AM
#15056   sold a bit more @ .58 my name is 01/16/18 11:29:23 AM
#15055   what a little beast. still holding half. my name is 01/12/18 10:37:11 PM
#15053   All exchanges have different listing requirements and within ehihub 01/12/18 11:53:44 AM
#15052   What I’m not sure I’m understanding is, doesn’t momoney163 01/12/18 11:22:06 AM
#15051   i just talk dollars and what makes cents. my name is 01/12/18 10:21:18 AM
#15050   Ok “my name is” I agree with calling ehihub 01/12/18 09:25:30 AM
#15049   bunch of lames on this board that don't my name is 01/12/18 08:08:04 AM
#15048   Welcome. You’re just in time. A little birdie momoney163 01/11/18 08:12:31 PM
#15047   Ummm ahem...Hi everyone my name is Randy I'm Darkmatter666 01/11/18 07:52:25 PM
#15046   Ive just watched all the YouTube video interviews ehihub 01/11/18 01:08:18 PM
#15045   I guess I shouldn’t complain too much if momoney163 01/11/18 11:25:15 AM
#15044   News almost every day huh. It’s part of momoney163 01/11/18 11:21:41 AM
#15043   HEB is poised to make real money. They ehihub 01/11/18 09:29:29 AM
#15042   That’s huge news from a manufacturing standpoint. tanuirunner 01/11/18 09:24:39 AM
#15041   NEWS Posted!!!! New Technology Simplifies, Speeds Production of Immuno-Oncology ehihub 01/11/18 08:49:26 AM
#15040   January 2nd interview with HEB CEO. It’s a ehihub 01/11/18 07:29:46 AM
#15039   thinking of jumping back in around .43-.46 my name is 01/10/18 08:57:26 PM
#15038   Hemispherx owns and operates a 30,000 sq. ft. ehihub 01/10/18 07:20:18 PM
#15037   Wondering if Ampligen might be good for the momoney163 01/10/18 02:53:02 PM
#15036   Just listened to the presentation at the conference. ehihub 01/10/18 01:29:43 PM
#15035   Report update and continued coverage: Hemispherx Biopharma, Inc. conix 01/10/18 09:16:50 AM
#15034   pump pump it up my name is 01/10/18 08:30:47 AM
#15033   HEB $$$ GOING MUCH HIGHER NOW HEB!!!IMO!! okwife 01/09/18 07:34:32 PM
#15032   had to take something off the table if my name is 01/09/18 12:08:59 PM
#15031   Yeah, this is the real deal, I live momoney163 01/09/18 11:21:33 AM
#15030   uh oh clay trader is posting must mean my name is 01/09/18 07:47:11 AM
#15029   * * $HEB Video Chart 01-08-18 * * ClayTrader 01/08/18 04:54:34 PM
#15028   Yeah I’ve been following this company for years, tanuirunner 01/08/18 03:03:10 PM
#15027   Indeed it does. Only bought 10k shares so WiseYoda 01/08/18 02:24:06 PM
#15026   I bought some this morning. Looks promising. eeprincipal 01/08/18 02:19:38 PM
#15025   Been reading up on HEB. The potential here WiseYoda 01/08/18 12:00:12 PM
#15023   coming out of the woodwork now. glad you my name is 12/22/17 11:09:52 AM
#15022   She broke 36, should run nicely from here tanuirunner 12/22/17 10:04:00 AM
#15021   If this breaks .36 she’ll run. Good time JBowsNose 12/21/17 03:47:55 PM
#15020   When did we move out of the OTC momoney163 12/20/17 02:48:15 PM
#15019   so you are a buyer or seller or heb? my name is 12/18/17 07:25:07 AM
#15018   Can I say it's not surprising you have courtpuppy 12/16/17 11:05:06 AM
#15017   goes much lower and i might exit. then my name is 12/14/17 08:44:25 PM
PostSubject