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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 Files Positive Safety Report on Intranasal Use of Ampligen in Combination with FluMist Influenza Vaccine 07/09/2018 08:30:00 AM
HEB News: Securities Registration Statement (simplified Form) (s-3) 07/03/2018 08:41:45 AM
HEB News: Hemispherx Notes the Importance of Immunizations During Upcoming National Immunization Awareness Month and Potential of Ampli... 07/03/2018 08:30:00 AM
HEB News: Securities Registration Statement (s-1) 07/02/2018 07:00:03 PM
HEB News: Hemispherx Opens FDA-Approved Reimbursement Based Expanded Access Treatment Program for ME/CFS to New Enrollees at Approved C... 06/27/2018 08:30:00 AM
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PostSubject
#15499   Yes and it was around 8/1 if I cash4me2 07/07/18 12:20:55 AM
#15498   .30 is the pre split price?? Oy vey. momoney163 07/07/18 12:14:33 AM
#15497   This already had a reverse split and now cash4me2 07/06/18 11:35:11 PM
#15496   Airplane I meant. momoney163 06/28/18 06:08:05 PM
#15495   Lol I’m referencing the “.... and don’t call momoney163 06/28/18 06:05:33 PM
#15494   mom=== Mom is short for momoney163==You should be smart oltimer 06/28/18 04:19:49 PM
#15493   .... and don’t call me mom, I’m not momoney163 06/28/18 01:53:34 PM
#15492   Same bs, I’m out. GL momoney163 06/27/18 11:54:35 AM
#15491   I’ll bet UNMC has never heard of Heb. momoney163 06/25/18 02:45:28 PM
#15490   I’m hearing a buyout at .30 though. momoney163 06/25/18 01:26:48 PM
#15489   I’m hearing .33 soon. Hahaha (yeah right.) momoney163 06/25/18 11:54:04 AM
#15488   This thing is getting ready shake rattle and oltimer 06/19/18 04:45:29 PM
#15487   Add to watchlist oltimer 06/19/18 04:35:11 PM
#15486   Volume seems too inconsistent if this is an momoney163 06/19/18 01:39:06 PM
#15485   mom You never know about a .30 cent stock. oltimer 06/19/18 01:25:40 PM
#15484   I don’t doubt them or you. I’m sure momoney163 06/19/18 11:48:50 AM
#15483   mom All i know they have a lot oltimer 06/18/18 07:59:04 PM
#15482   Waiting on that $10,- HelloKitty8 06/18/18 07:40:28 PM
#15481   What the hell is wrong with this stock? momoney163 06/18/18 02:56:54 PM
#15480   6/15: Hemispherx Releases First 8,500 Vial Lot of Saskey 06/18/18 09:11:53 AM
#15479   NEWS OUT===== oltimer 06/15/18 11:22:05 AM
#15478   ..... to .31 is more like it. momoney163 06/14/18 03:34:03 PM
#15477   Who mentioned NWBO? God I hope not, then momoney163 06/07/18 11:28:27 AM
#15476   I'm in. Looking good :-) Go HEB go! Saskey 06/06/18 11:34:38 AM
#15475   encouraging PR's hopefully slow climb to 40 shurtha2000 06/06/18 12:40:09 AM
#15474   Roswell?? Sounds like they’ll be experimenting with aliens. momoney163 06/01/18 12:58:40 PM
#15473   stock== I have been buying a little bit at oltimer 05/31/18 09:03:06 PM
#15472   Still here and actually picked up more shares stockguard 05/31/18 04:18:10 PM
#15471   =====Where did everybody go?===== oltimer 05/31/18 03:16:16 PM
#15470   Yeah, it’s a fraud. ;-( momoney163 05/30/18 07:03:33 PM
#15469   Ahh, I think I’m slowly realizing I’ve been momoney163 05/23/18 05:07:20 PM
#15468   Yes the right to try should help the stockguard 05/23/18 10:14:23 AM
#15467   stock== That should help HEB. Are you still buying. oltimer 05/23/18 10:03:51 AM
#15466   Right-to-try' bill passes Congress stockguard 05/23/18 09:48:22 AM
#15465   Lolz, lolz, lolz. Veer schmeer. momoney163 05/22/18 07:27:53 PM
#15464   LOL (-; stockguard 05/21/18 03:54:54 PM
#15463   stock=== It took 15 t0 20 thousand trades oltimer 05/21/18 03:41:25 PM
#15462   stock= I read some where that the Sabby outfit oltimer 05/21/18 03:21:22 PM
#15461   mom==== That is the way you make big money oltimer 05/21/18 03:07:07 PM
#15460   oltimer I bought another 10,000 also. I have a stockguard 05/21/18 02:51:25 PM
#15459   You must mean your group? No disrespect seriously momoney163 05/21/18 02:06:05 PM
#15458   ===mom==== It means buying opt to me so I oltimer 05/21/18 01:48:09 PM
#15457   What is the 50Dma is, what it means.? momoney163 05/21/18 11:43:22 AM
#15456   I feel like we are going to have oltimer 05/20/18 08:03:21 PM
#15455   stock=== I agree with every thing that you are oltimer 05/19/18 05:45:16 PM
#15454   Some interesting back and forth on Yahoo message stockguard 05/19/18 05:36:18 PM
#15452   stock===== I have already double my pos twice and oltimer 05/19/18 01:35:13 PM
#15451   This is even better and I checked it stockguard 05/19/18 01:21:26 PM
#15450   stock===== That is good news. The stock is action oltimer 05/18/18 01:09:15 PM
#15449   Insider and CFO Adam Pascale picked up his stockguard 05/18/18 12:31:09 PM
PostSubject