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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: Statement of Ownership (sc 13g) 09:33 AM
HEB News: Prospectus Filed Pursuant to Rule 424(b)(5) (424b5) 04/20/2018 05:31:43 PM
HEB News: Current Report Filing (8-k) 04/20/2018 05:31:17 PM
HEB News: Hemispherx Announces Pricing of $2.57 Million Registered Direct Offering at a Premium to Market 04/20/2018 09:28:06 AM
HEB News: Statement of Changes in Beneficial Ownership (4) 04/19/2018 03:35:57 PM
News News Alert: Statement of Ownership (sc 13g) 04/24/2018 09:33:08 AM
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#15374   Looking better today. I double my pos and oltimer 04/24/18 12:16:53 PM
#15373   Funny how HEB seems to run with the momoney163 04/24/18 11:18:20 AM
#15372   My other holdings doing incredible well. Packed 100% jimbosskow 04/24/18 10:51:13 AM
#15371   Yeah but not in my ideal area to Beerholder 04/24/18 09:57:11 AM
#15370   Green market today. :) jimbosskow 04/24/18 09:55:47 AM
#15369   That app shows 5000 bought this morning Beerholder 04/24/18 09:35:05 AM
#15368   Everyone who added. jimbosskow 04/24/18 07:35:15 AM
#15367   if it ran to .4 who would make money? my name is 04/23/18 08:55:29 PM
#15366   It’s always a learning process. Every co is jimbosskow 04/23/18 07:25:03 PM
#15365   Same here but I don’t know I thought Beerholder 04/23/18 04:55:25 PM
#15364   Not looking good today, lot of selling. jimbosskow 04/23/18 03:02:33 PM
#15363   I open a position when indicators tell me jimbosskow 04/23/18 02:15:21 PM
#15362   I understand I’ve been holding sold some at Beerholder 04/23/18 01:56:23 PM
#15361   Well, see that’s just what I’m talking about. momoney163 04/23/18 01:55:08 PM
#15360   Lol I got in at 35 new I Beerholder 04/23/18 01:43:59 PM
#15359   9 bucks here. I don’t invest the farm momoney163 04/23/18 11:36:33 AM
#15358   9.00 momoney163 04/23/18 11:31:37 AM
#15357   My risk strategy has brought me down only Beerholder 04/21/18 11:16:58 AM
#15356   I’m down $2100,- on $HEB jimbosskow 04/21/18 08:12:03 AM
#15355   ok who is goong to admit how much my name is 04/20/18 09:46:41 PM
#15354   ... to something good or even spectacular. momoney163 04/20/18 05:16:09 PM
#15353   Anybody who read the details knows that half jimbosskow 04/20/18 04:52:22 PM
#15352   jimboss I thought the stock acted pretty good today. oltimer 04/20/18 04:29:28 PM
#15351   Thank God $GOHE had a nice pop today. jimbosskow 04/20/18 04:12:35 PM
#15350   jimboss That htbx is doing the same thing that oltimer 04/20/18 03:30:44 PM
#15349   jimboss oltimer 04/20/18 03:18:45 PM
#15348   jimboss Looks like we are getting a steal down oltimer 04/20/18 03:16:06 PM
#15347   https://seekingalpha.com/news/3347257-hemispherx-secures-private-2_57m-capital-r jimbosskow 04/20/18 02:40:41 PM
#15346   $HEB France is up.... jimbosskow 04/20/18 01:08:32 PM
#15345   Close to what? jimbosskow 04/20/18 01:05:53 PM
#15344   Ooh, so close. momoney163 04/20/18 01:04:10 PM
#15343   Here are the exact times. I was hoping jimbosskow 04/20/18 11:48:24 AM
#15342   MACD is on my pic too. You have jimbosskow 04/20/18 11:43:00 AM
#15341   When? I just said to spark some excitement. momoney163 04/20/18 11:40:45 AM
#15340   I thought it was mainly in the macd momoney163 04/20/18 11:36:07 AM
#15339   None of the tutes sold their positions. As jimbosskow 04/20/18 11:33:54 AM
#15338   That app is sweet thanks for that the Beerholder 04/20/18 11:22:00 AM
#15337   That is a million dollars question. The RSI jimbosskow 04/20/18 11:10:28 AM
#15336   jimbosskow 04/20/18 10:47:12 AM
#15335   Anybody knows why was it halted twice? jimbosskow 04/20/18 10:47:12 AM
#15334   mom=== I don't no what every body else is oltimer 04/20/18 10:43:39 AM
#15333   Webull jimbosskow 04/20/18 10:33:18 AM
#15332   Jimbo, oldtimer, you guys sound like pros. How momoney163 04/20/18 10:26:28 AM
#15331   What app is that e-trad Beerholder 04/20/18 10:24:47 AM
#15330   Oh I’m holding for now. Big boys are jimbosskow 04/20/18 10:23:49 AM
#15329   Wasn’t saying every one should but I did. Lol Beerholder 04/20/18 10:14:17 AM
#15328   Got you. jimbosskow 04/20/18 10:13:35 AM
#15327   I sold and put in a new bid Beerholder 04/20/18 10:10:48 AM
#15326   More dilution.... jimbosskow 04/20/18 10:10:25 AM
#15325   I’m out till 34 cents seems as if Beerholder 04/20/18 10:09:14 AM
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