Monday, April 28, 2014

Hemispherx Biopharma, HEB, Profile, Summary

Hemispherx Biopharma, HEB, Profile, Summary



Hemispherx Biopharma, HEB, is a biopharmaceutical company dedicated to treating and preventing chronic viral and immune-based disorders through the development and manufacturing of compounds that enhance the natural immune system of the human body. Hemispherx Biopharma, has developed over nearly three decades a vast body of knowledge relating to a potentially new class of pharmaceutical products (nucleic acid compounds) that are designed to activate otherwise dormant cellular defenses against viruses and tumors.
The Company’s flagship products include Alferon N Injection® and the experimental immunotherapeutics Ampligen®. Its platform technology includes large and small agents for potential treatment of various chronic viral infections.
Ampligen®, is a new class of specifically-configured ribonucleic acid (RNA) compounds targeted at such important diseases as Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME), HIV, Hepatitis B, Hepatitis C, and cancers including kidney cancer and metastatic malignant melanoma.
Alferon N Injection® (interferon alfa-n3, human leukocyte derived) is a highly purified, natural source, glycosylated, multi-species alpha interferon product, composed of eight forms of high-purified alpha interferon.  It is the only natural source, multi-species alfa interferon currently sold in the United States and is also approved for sale Argentina. Alferon N Injection® is the company’s registered trademark for it’s injectible formulation or natural alpha interferon approved by the FDA for the treatment of genital HPV (refractory condylomata acuminata). Alferon N Injection® may also have activity against other viral infections such as Multiple Sclerosis, Hepatitis C, HIV, West Nile Virus, and SARS, but has not been approved for that use.

Ampligen®

Ampligen®, the company's lead compound addresses a variety of chronic diseases and viral disorders. Ampligen® drugs for several viral disorders are under development. More than 40,000 doses at over 20 U.S. clinical trial sites have been delivered with Ampligen®.

ALFERON N Injection®

ALFERON N Injection® [Interferon alfa-n3 (human leukocyte derived)] is the Company's registered trademark for its injectable formulation of Natural Alpha Interferon, approved by the U.S. Food and Drug Administration (FDA) for the intralesional treatment of refractory or recurring external condylomata acuminata in patients 18 years of age or older.
ALFERON N Injection® is the only highly purified, natural-source, multispecies alpha interferon product currently sold in the U.S. and is also approved for sale in Argentina.
Clinically Effective:
  • All warts disappeared in 54% of patients.3
  • No recurrence in 76% of complete responders at follow-up.3
  • Completely cleared 73% of all treated warts.3,4
  • No human antibodies to interferon alfa-n3 detected in clinical trails.3,4
  • Provides a spectrum of multiple alpha interferon subtypes.1,2
Well-tolerated
  • No surgery or caustics and resultant ulceration or scarring.
  • No specific post-treatment care necessary.4
  • The most common adverse effects (mild to moderate, transient flu-like symptoms) were comparable to placebo after 304 weeks of therapy.3.4
  • The majority of patients considered Alferon N Injection preferable to conventional therapy. 3.4
Please see the package insert for prescribing information.



Alferon Low Dose Oral (LDO)®
Alferon LDO®, Hemispherx's oral form of Our Anferon N product (Low Dose Oral Interferon Alfa-N3, Human Leukocyte Derived), which is a new delivery form of our FDA approved drug, Alferon N® is the only natural interferon currently FDA approved and available in the marketplace. Hemispherx has initiated clinical trials as part of an accelerated evaluation of the experimental bio-therapeutic Alferon LDO (Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived)) as a potential new experimental therapy for Avian Flu and other lethal viral diseases, which have high acute death rates. Clinical trials in human volunteers (being conducted in both the U.S. at Drexel University, Philadelphia, and shortly to commence in Hong Kong at the Princess Margaret Hospital) are designed to determine whether Alferon N, delivered in a new, experimental oral drug delivery format, can resuscitate the broad-spectrum antiviral and immunostimulatory genes. These human genes are shut down by acute lethal viral infections such as avian flu and smallpox


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HPV, HIV, Chronic Fatigue Syndrome (CFS), Hepatitis, influenza, H5N1, H7N9, avian influenza, drug resistant avian influenza, Hepatitis A, viral, bacterial, viral infections, Multiple Sclerosis, Hepatitis C, West Nile Virus, SARS, FDA. CIDC.

Monday, March 31, 2014

Bacterin International, BONE, Profile, Summary

Bacterin International, BONE, Profile, Summary


Bacterin International Holdings (NYSE: BONE), a developer of bioactive coatings for medical applications and revolutionary bone graft material, processes and markets innovative, biologic allografts for transplantation. The Company’s biologic scaffolds, OsteoSponge®, OsteoSponge® SC and OsteoWrap®, are made from demineralized bone that is malleable and flexible, which enables more efficient and precise handling. It also markets BacFast® and OsteoLock®, which are used in spine surgery, designed to minimize graft back-out, and increase osteoinductivity. Bacterin's latest allograft, OsteoSelect® DBM Putty has excellent handling characteristics and is distributed as a sterile product, with osteoinductivity testing completed on every lot after terminal sterilization.


Bacterin’s Medical Device and Coatings Division focuses on the development of bioactive coating technologies for implantable devices. It’s core competency is anti-microbial coatings designed to reduce potential infections associated with implants, thus improving rates of healthcare-associated infections and associated costs. This Division also manages surgical kits necessary to support implantation of products processed by Bacterin’s Biologics Division.


Bacterin is an accredited tissue bank and medical device company that designs, processes, manufactures, and markets advanced medical products. Using designs focused on efficacy and safety for the patient, and functionality and ease of use for the surgeon. Bacterin is a specialty tissue bank focused on processing and distributing quality, cost-effective allografts. Bacterin operates a 32,000 sq. ft., state-of-the-art, fully compliant and FDA registered facility, equipped with five "Class 100" clean room




Bone, skin, sking grafts, plastic surgery, osteo sponge, biologics, bone grafts, osteeporosis. Menopause, post menopause, Bacterin, natural medical devices.