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Last Post: 11/16/2017 12:53:24 AM - Followers: 232 - Board type: Free - Posts Today: 0

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: Securities Registration (section 12(b)) (8-a12b) 11/14/2017 05:09:06 PM
HEB News: Quarterly Report (10-q) 11/14/2017 03:29:09 PM
HEB News: Notice of Effectiveness (effect) 10/13/2017 06:01:46 AM
HEB News: Prospectus Filed Pursuant to Rule 424(b)(3) (424b3) 10/12/2017 05:02:40 PM
HEB News: Securities Registration Statement (s-1) 09/29/2017 05:29:58 PM
PostSubject
#15013   wish this thing would hurry up and get my name is 11/16/17 12:53:24 AM
#15012   Crossed over .36 early in the day, l T695 10/13/17 09:59:47 PM
#15011   Oh? Why? drkazmd65 10/13/17 09:31:58 PM
#15010   Watch for major run today T695 10/13/17 09:39:22 AM
#15009   this could breakout to at least .43 at T695 10/12/17 02:59:53 PM
#15008   $HEB * Hemispherx Biopharma-? Ampligen appears to be Boctoc 10/10/17 10:06:44 PM
#15007   Watch for a break out over .36 T695 10/10/17 11:29:25 AM
#15006   Is it a possible swing trade? Chart looks good. Dmwcrash 10/10/17 09:29:30 AM
#15005   Dude have been a shareholder here in the drkazmd65 10/09/17 10:50:41 AM
#15004   I agree. Been in this stock for a Boctoc 10/09/17 10:43:09 AM
#15003   Just buy some and thank me later T695 10/09/17 10:30:51 AM
#15002   Apparently not. drkazmd65 10/09/17 10:15:48 AM
#15001   It's obvious T695 10/09/17 10:06:00 AM
#15000   Why? I ask not to be insulting drkazmd65 10/07/17 02:57:52 PM
#14999   This will double soon T695 10/06/17 04:35:27 PM
#14998   buy today for next weeks bounce T695 10/06/17 03:38:33 PM
#14997   More dilution Jumpinjackas 09/30/17 03:38:54 PM
#14996   Increasing volume. Mergers news are coming ;) diegonalesso 09/25/17 02:46:03 PM
#14995   need some news here - volume coming in shurtha2000 09/25/17 11:35:36 AM
#14994   Just like in the Biggies Smalls song..... n3m3sis 09/01/17 02:16:48 PM
#14993   Another Flurry of Insider Buying....... n3m3sis 08/17/17 04:43:29 AM
#14992   This is the same band of thieves as deniseann 08/15/17 10:14:13 PM
#14988   going back over .50 soon shurtha2000 07/11/17 10:24:04 AM
#14986   HEB investors wake up! beskeptical 07/10/17 04:55:47 PM
#14985   This could be the wildest wild card I shurtha2000 07/10/17 09:27:13 AM
#14984   Just read in a business journal that they momoney163 06/16/17 03:46:44 PM
#14983   Ampligen being used for pancreatic cancer in Europe shurtha2000 04/30/17 06:57:59 PM
#14982   Yes, massive insider buying. Gap to fill at deadboy 04/27/17 02:47:04 PM
#14981   CEO accumulating shares is always a good sign, SchlumpyStock-Picker 04/27/17 10:08:02 AM
#14980   Deep pipeline and anticipation of FDA approvals. deadboy 04/25/17 09:39:06 AM
#14979   HEB up bigly today. Over 25%. Anyone know why? ksuave 04/24/17 03:46:15 PM
#14978   Here is the latest forecast JJ n3m3sis 04/02/17 02:49:50 PM
#14977   There is a target price of $11.68 on JJ1223 03/21/17 12:24:42 PM
#14976   Well it's safe to say that they are borbash 03/07/17 07:29:10 AM
#14975   More gains today? n3m3sis 03/07/17 06:20:45 AM
#14974   Here we go ammoking 03/02/17 02:05:25 PM
#14973   Hold on to your shares, we are going Boognishmang 02/23/17 02:04:00 PM
#14972   Gaining momentum ammoking 02/13/17 01:58:49 PM
#14971   two bits willlbone 02/02/17 09:39:16 AM
#14970   Heb did reverse split so whats next? myann 01/09/17 05:46:40 PM
#14969   Management still adding n * Equels Thomas K. 2. Issuer Name Richard2 12/27/16 11:14:18 PM
#14968   No Jumpinjackas 12/08/16 02:30:14 AM
#14967   Opinions please. Will this help us http://wtop.com/government/2016/12/senate-nea Richard2 12/07/16 11:08:11 AM
#14966   Almost... There Jumpinjackas 10/17/16 01:17:07 PM
#14965   http://www.stockhouse.com/news/press-releases/2016/10/13/theralase-demonstrates- itsallgood11 10/13/16 02:33:10 PM
#14964   Yup, this will be back under a dollar tanuirunner 08/31/16 08:47:05 AM
#14963   And the offering... Still same scaaam Jumpinjackas 08/31/16 08:44:35 AM
#14962   Received a threatening letter from the company because otterman 08/30/16 12:20:57 PM
#14961   R/s happened today, 1:12 tanuirunner 08/29/16 08:36:49 AM
#14960   Wasn't this supposed to RS before trading yesterday? MDizzle 08/27/16 07:49:33 AM
PostSubject