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Great to break on through...
News coming?!?
GLTA
Yeah but not til Thursday.
Maybe the frivolous law suits have been outed.
I think you might be right lol
Hopefully everyone of concern with Ampligen gets great news before years end.
GLTA
Great to see the gains.
Wonder if there's a leak somewhere?!?
Happy Thanksgiving to everyone.
GLTA
All good points; HEB would be a strong competitor.
Pending approval, wonder who HEB would collaborate with
for worldwide distribution.
It's got to be a big boy pharma.
GLTA
HEB Long
Agree and wondering how much a rumor of a buy-out would raise the pps?
Ready to ride the rocket!
GLTA
HEB Long
Agree with the take on post-approval issues but still wonder what the FDA's view is.
Still Holding steady and thanks for the info.
Original FDA acceptance was July 7, 2008.
That takes us up to 16.1 months now.
What has been the average response time?
Was it 17.2?
GLTA
HEB Long
Hasegawa et al Patent App for Nasal vacine:
United States Patent Application 20090214596
Kind Code A1
Seino; Ken-ichiro ; et al. August 27, 2009
--------------------------------------------------------------------------------
Nasal Vaccine
Abstract
The present invention provides a nasal vaccine capable of intranasally inducing an effective immunity reaction. Specifically, the invention provides a nasal vaccine containing a compound having an NKT cell-activating action, particularly a compound represented by the formula (I): ##STR00001## wherein each symbol is as defined in the specification, or a compound represented by the formula (II): ##STR00002## wherein each symbol is as defined in the specification, and an immunogen in an amount effective for stimulating an immune response.
Full application found here:
http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=1&f=G&l=50&co1=AND&d=PG01&s1=hasegawa.IN.&s2=riken.AS.&OS=IN/hasegawa+AND+AN/riken&RS=IN/hasegawa+AND+AN/riken
Anyone know the formula for Ampligen?
Interested in comparing.
Application filed March 30, 2006
Assignee: RIKEN
Thanks for the post. Note this statement:
The Company is finalizing certain responses with respect to third-party based animal toxicology and manufacturing programs it believes should be considered post-approval issues and that do not constitute new or additional FDA requests.
HEB believes these responses should be post-approval but does the FDA?
GLTA
HEB Long
Looking for news from Japan, anyone?
recent news search showing releases from 2008.
I couldn't agree with you more.
...bash stock they r not even in. Why waste time???
It's amazing that people don't really understand what it takes for biopharma co's to develop and get a drug ready for FDA NDA.
Take a look at this GSK webpage statement:
Key fact
Developing a new medicine
costs over $500 million and
takes over 12 years.
Most people need to realize the FDA is in constant communication with every company that applies for NDA.
The FDA posts the approval letters and sites all the submissions dates.
Complicated process getting FDA approval but worth the wait.
Glad I do my own DD. Plus some great info from you and others here at iHub.
Thanks and GLTA
HEB Long
PR Oct 26 and Oct 23rd paperwork from Dr. Hasegawa
http://www.hemispherx.net/content/investor/default.asp?goto=654
Japanese NIH Expands Pandemic Flu Protective Potential by Ampligen®
......New Publication Suggests Pandemic Vaccines Adjuvanted are More Effective; The Potential Importance of Antigen Sparing and Cross-Protective Formulations
http://www.ncbi.nlm.nih.gov/pubmed/19840660?ordinalpos=1&itool=PPMCLayout.PPMCAppController.PPMCArticlePage.PPMCPubmedRA&linkpos=4
from Vaccine. 2009 Oct 23;27(45):6276-9
Title: PolyI:polyC12U adjuvant-combined intranasal vaccine protects mice against highly pathogenic H5N1 influenza virus variants.
New AbstractPlus from Japan, Dr. Hasegawa: PolyI:polyC12U adjuvant-combined intranasal vaccine protects mice against highly pathogenic H5N1 influenza virus variants.
Vaccine. 2009 Oct 23;27(45):6276-9
by Ichinohe T, Ainai A, Tashiro M, Sata T, Hasegawa H.
Department of Pathology, National Institute of Infectious Diseases, 4-7-1 Gakuen, Musashimurayama-shi, Tokyo, Japan.
http://www.ncbi.nlm.nih.gov/pubmed/19840660?ordinalpos=1&itool=PPMCLayout.PPMCAppController.PPMCArticlePage.PPMCPubmedRA&linkpos=4
The highly pathogenic avian H5N1 influenza virus has the potential to incite a global pandemic. Therefore, there is an urgent need to develop effective vaccines against these viruses. Because it is difficult to predict which strain of influenza will cause a pandemic, it is advantageous to develop vaccines that will confer cross-protective immunity against variants of the influenza virus.
Recently, we reported that the Toll-like receptor 3 agonist, polyI:polyC(12)U (Ampligen), has been proven to be safe in a Phase III human trial, and is an effective mucosal adjuvant for intranasal H5N1 influenza vaccination.
Intranasal administration of an Ampligen adjuvanted pre-pandemic H5N1 vaccine (NIBRG14), which was derived from the A/Vietnam/1194/2004 strain, resulted in the secretion of vaccine-specific IgA and IgG in nasal mucosa and serum, respectively, and protected mice against homologous A/Vietnam/1194/2004 and heterologous A/Hong Kong/483/97 and A/Indonesia/6/2005 viral challenge.
PMID: 19840660 [PubMed - in process]
______________________________________
Finally getting documentation from Japan.
Great article - thanks for posting.
How about that? X-associated neuroimmune disease
“It’s amazing to me that anyone could look at these patients and not see that this is an infectious disease that has ruined lives,” Dr. Mikovits said.
She has also given the disease a properly scientific new name: X-associated neuroimmune disease.
A Case of Chronic Denial
By HILLARY JOHNSON
Published: October 20, 2009
The NEW YORK TIMES
If XMRX is found in 4% of healthy population, wonder if that portion of the population is more affected by the H1N1 virus?
I wonder if Ampligen would help those individuals?
Checking the 10-Q, August 7, 2009
On September 19, 2008, we executed an agreement with Lovelace Respiratory Research Institute in Albuquerque, New Mexico to perform certain animal toxic studies in support of our Ampligen® NDA.
These studies were requested by the FDA and will be done in collaboration with the resources of the New Brunswick facility.
These studies have been substantially completed with summary reports expected to be issued to the FDA during the third quarter of 2009.
Data for final FDA reports are presently undergoing internal auditing at Lovelace and Hemispherx with a projected completion of the final report for late 2009 to early 2010.
The FDA may have decided already. They could be withholding the final approval until they get all items checked off their list and this may one of two items, IMO, not completed.
IMO, the other is the pending recommendation from the Seattle FDA office.
The FDA conducted a field inspection at Hollister-Stier Laboratories in Spokane, Washington in mid-2008.
The Ampligen® final fill operations are performed under contract with Hollister-Stier.
The inspection resulted in a FDA Form 483 with two observations dealing with reviews and validations of process variability.
We continue to work with Hollister-Stier to finalize specific actions to address the FDA Form 483 issues and Hollister-Stier has submitted a specific action plan to the Seattle, Washington office of the FDA.
It is our expectation that these issues will be resolved and we will be able to complete the resultant sequential validations by the end of 2009.
Hopefully these two items are completed sooner than later.
It's been a long dance.
GLTA
HEB Long
I like the reviews you post. Excellent snap of trends, thanks.
I agree that we are close and it feels like somethings about to happen. Like a Volcano, I hope.
Code of Ethics ammendments could amount to housekeeping, IMO.
Dr. Carter talked about a check list.
The amendments would put them closer to EHS and ISO compliance and certification.
...the Board of Directors of Hemispherx Biopharma, Inc. (the "Company"), upon the recommendation of the Audit Committee of the Board of Directors, approved amendments to the Company's Code of Ethics.
The Corporate Governance Guidelines (Feb 2007) states that independent contractors where to be included in the Code of Ethics. Apparently the original Code didn't incorporated them.
http://www.hemispherx.net/content/corp/Corporate%20Governance%20Guidelines.pdf
Looks to me like the results of a review of the company policies and practices.
GTLA
HEB Long
Company Highlights up to Dr. Carter's recent interview
http://www.istockanalyst.com/article/viewarticlepaged/articleid/3546991/pageid/1
On 7/7/08, the FDA accepted for review Hemispherx Biopharma's (AMEX: HEB: 1.83, 0.05) ($1.81) NDA for Ampligen to treat chronic fatigue syndrome (CFS), which was originally submitted in October 2007. The NDA for Ampligen (poly I : poly C12U) is also the first ever accepted for review by the FDA for systemic use of a toll-like receptor therapy to treat any condition and there are currently no FDA-approved treatments for CFS. On 2/18/09, HEB was notified by the FDA that the originally scheduled PDUFA action date was extended by three months to 5/25/09. On 5/22/09, HEB was notified by the FDA that it may require up to one to two additional weeks to take action beyond the scheduled PDUFA action date. However, since that date, no further notification has been received from the FDA.
On 10/9/09, BioMedReports.com conducted an interview with HEB's CEO, Dr. William Carter for an update on the Ampligen NDA status. Dr. Carter stated that HEB expects to complete a set of preclinical toxicology reports during 4Q09. In addition, the Agency has conducted inspections of manufacturing facilities over the past 12 months which required no corrective actions by HEB. However, the FDA noted certain compliance issues with "fill and finish" facilities and took corrective actions with its own facilities in NJ and is about to complete remediation actions in the next several weeks in the contract lab in WA with a report to the FDA pending. In addition, animal toxicology studies conducted by Lovelace Respiratory Research Institute in NM in support of the Ampligen NDA and at the request of the FDA are currently undergoing auditing and expected to be completed by late 2009 to early 2010.
GLTA
HEB Long
Thanks for the update. I agree with 3 cents target.
GLTA
Posted Oct. 7th but thanks:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=42289272
Thanks for the post. This is exciting news for Ampligen.
There's a possible application to fight prostate cancer in patients with a deficiency of NK (Natural Killer) cell activity.
GLTA
HEB Long
Lets hope 23rd but mid-Nov would be OK by me.
Your Wedding? Congrats!
...I would not expect anything till mid november at least...
IMO by Oct. 23rd.
Although, I keep thinking about the 10-Q (August 7, 2009) statements about the third party facility and the toxic test results (pg. 22).
Most important is this:
A satisfactory recommendation from the FDA Office of Compliance based upon an acceptable preapproval inspection is required prior to approval of the product.
Looks like two issues:
(1)
The FDA conducted a field inspection at Hollister-Stier Laboratories in Spokane, Washington in mid-2008. The Ampligen® final fill operations are performed under contract with Hollister-Stier. The inspection resulted in a FDA Form 483 with two observations dealing with reviews and validations of process variability. We continue to work with Hollister-Stier to finalize specific actions to address the FDA Form 483 issues and Hollister-Stier has submitted a specific action plan to the Seattle, Washington office of the FDA. It is our expectation that these issues will be resolved and we will be able to complete the resultant sequential validations by the end of 2009.
(2)
On September 19, 2008, we executed an agreement with Lovelace Respiratory Research Institute in Albuquerque, New Mexico to perform certain animal toxic studies in support of our Ampligen® NDA. These studies were requested by the FDA and will be done in collaboration with the resources of the New Brunswick facility. These studies have been substantially completed with summary reports expected to be issued to the FDA during the third quarter of 2009. Data for final FDA reports are presently undergoing internal auditing at Lovelace and Hemispherx with a projected completion of the final report for late 2009 to early 2010.
If there is a satisfactory recommendation and the studies are completed, we're on the home stretch.
GLTA
HEB Long
Hunter-Hopkins Center monthly newsletter
For complete email newsletter click link below:
http://www.drlapp.net/ME_letterOct09P.pdf
Highlights of Contents
Excitement About XMRV – a CFS-Related Virus!
and
Ampligen Update
XMRV – Newly Discovered CFS-Related Virus
There is no known treatment for XMRV although the experimental drug Ampligen may modulate the
RNaseL system, and therapies are available for other retroviruses such as HIV.
Ampligen Update
Hunter-Hopkins is one of two centers in the world providing Ampligen to Persons with CFS (PWCs). The
other center is Dr. Dan Peterson’s clinic associated with the Whittemore-Peterson Institute.
We have recently modernized our infusion facilities, and have just evaluated three more individuals to start
Ampligen treatment under the cost-recovery (aka compassionate care) AMP-511 Protocol.
___________________________________
GLTA
HEB Long
CFS as heard on Good Morning America
9/24/09 Tanya Rivero interviews Dr. Donnica Moore.
Dr. Moore is editor-in-chief of WOMEN'S HEALTH FOR LIFE.
What is CFS?
How is it diagnosed?
How is it treated?
Dr. Moore talks about treatment frustrations and one drug currently up for review with the FDA that lots have great hope for!
(About 4 1/2 minutes into the interview.)
ABC News link found on yahoo:
http://abcnews.go.com/Video/playerIndex?id=8664151
GLTA
HEB Long
Oct 10th Dr. Hasegawa to present on “Mucosal Immunity”
JAPAN-FRANCE Vaccine and Infectious Diseases Workshop in Osaka
http://www.bio-kansai.org/files/091011_workshop.pdf
Hopefully he will present the data from his <abstract>:
“Formulations and Efficacy of the Influenza Vaccine administered intranasally”
http://www.hemispherx.net/content/corp/JIID09927.pdf
Great News.
I'm glad the research continues to show the huge benefits and potential from Ampligen.
There are a lot of papers and ongoing efforts, Worldwide, to put Ampligen to it's best uses.
Take a look at over 100 documents for Ampligen here:
http://www.ncbi.nlm.nih.gov/pubmed
GLTA
HEB Long
Do you think the pps dip raked in some stop limits & shorts?
Hemispherx's Vaccine Enhancer Making Waves In Japan (AMEX: HEB)
By: Jay Garcilazo Tuesday, September 29, 2009 9:16 AM
http://www.istockanalyst.com/article/viewarticle/articleid/3512568#
Hemispherx Biopharma, Inc. (AMEX:HEB: 2.02, -0.03) is in the news after it was announced that Dr. Hasegawa the director of the Japanese National Institute of Infectious Diseases presented data on the lead compounds of Ampligen (R) (Poly I : Poly C12U) the double stranded RNA. The paper was titled "Formulations and Efficacy of the Influenza Vaccine Administered Intranasally," at the 13th Conference of the Japanese Society of Vaccinology. The vaccine enhancer is making waves at the Vaccinology conference after the release of the data.
Dr. Hasegawa's paper and data showed that there may be cross protection against mutated strains of viruses with the formulation of pandemic vaccine mixed with Ampligen (R). The therapeutic data shows this, increases the immunogenicity and therefore could help to protect against mutated strains of the virus.
Hemispherx Biopharma specializes in the advances of new drug treatments for seriously debilitating disorders and developed Ampligen ® as an experimental nucleic acid with the potential to treat global viral diseases and disorders. The company is still in the process of experimental studies to access the efficiency of Ampligen ® against influenza viruses. They have manufacturing facilities in New Brunswick, New Jersey for their bio pharmaceuticals, including Alferon LDO ®, Alferon N Injection ®,
I agree.
This should be more than enough to put us over the top, IMO.
You know speculating can get you in trouble, but then again, so can collusion.
Maybe Dr. Carter is just waiting until tomorrow to release a PR.?
GLTA
Abstract now on Hemispherx website:
http://www.hemispherx.net/content/corp/JIID09927.pdf
At The Annual Conference of the Japanese Society For Vaccinology held in Sapporo, Japan
on September 27, 2009, Dr. Hideki Hasegawa of National Institute of Infectious Diseases was scheduled to give the following presentation:
<Abstract,ed.>
“Formulations and Efficacy of the Influenza Vaccine administered intranasally”
Hideki Hasegawa, M.D. Ph.D.
National Institute of Infectious Diseases, Tokyo
Objectives and Significance
The important way for the prevention of influenza virus will be the mucous immunity such as IgA on the infected site. If we want to induce the mucous immunity, the intranasal vaccine shall be effective. In the present study, the avian influenza vaccine administered intranasallywas studied with regards to its efficacy, a volume of adjuvant as well as the mucous viscosity enhancer.
Materials and Method
Formalin-inactivated whole virion H5N1 vaccine was used.
Double stranded RNA, Ampligen®(poly I:polyC12U) was used as an adjuvant because its safety in human has been confirmed.
Vaccine antigen and adjuvant Ampligen®were mixed at the rate of 1:10 and 1:20.
The vaccine formulation which also includes an viscosity enhancer, was administered in monkeys (cynomolgus macaques).
Results
By the intranasal administration of H5N1 vaccine combined with an adjuvant, specific IgG and IgA antibodies were induced in all monkeys. When the immunogen was fixed, the increased adjuvant concentration 1:20 was demonstrated to produce more potent antibody response. In addition, when a viscosity enhancer was employed into the formulation, a higher concentration of the viscosity enhancer was found to increase IgA. But there was no significant difference with IgG.
Discussions
Avian influenza vaccine mixed with adjuvant and viscosity enhancer was administered in monkeys (cynomolgus macaques) which are known to have a wide nostril as human.
When a higher volume of an adjuvant and viscosity enhancer were administered in monkeys intranasally, the mucosal immunogenicity were enhanced.
This formulation is expected to demonstrate the cross protection against the mutated strain, so that this can be useful for the prevention of influenza virus in the future.
______________________________________
This is the abstract, ed., looking forward to the pub. paper and presentation by Dr. Hasegawa.
GLTA
HEB Long
Found on Yahoo: Link to Japanese Society of Vaccinology
Tried the auto-translation and couldn't get much information about this weekends conference:
http://65.55.177.205/BV.aspx?ref=IE8Activity&a=http://www.jsvac.jp/meeting_2.htm
Maybe someone else will have better luck than me.
Here are some bits and pieces from another translator:
National Institute of Infectious Diseases - one
# 1 / 2
Intranasal influenza vaccine development
Hasegawa Hideki Infectious Pathology Division, National Institute of Infectious Diseases, Other
持the ability to defend against the mutant virus protection and cross-protective response by influenza virus infection
The purpose of developing one of influenza vaccine has been developed mucosal vaccine type.
The immunity induced by influenza virus infection-induced serum neutralizing antibodies (IgG anti -
Body), which is secreted on the mucosal IgA antibodies, cytotoxic T cells that can give the other, one of those special
Secreted on the mucosal IgA antibodies in local work to defend against infection, disease and by its cross-reactivity
Strong defense mechanism that mutations in centromere. Mucosal immunity, such as anti-influenza virus frequently
Particularly effective against pathogens that infect via the mucosa of the neurogenic mutations. Currently, our country has been inoculated with
After the onset of flu vaccine that will prevent infection and infection-fighting purposes and the prevention of severe
Not intended. We aim for the purpose of flu vaccine to defend against infection, Lee
Inactivated vaccines are safe for the mucosal immunity induced by natural infection Nfuruenzauirusu
That they studied how to induce. Induce effective mucosal immunity by intranasal inoculation of inactivated vaccine
The mucosal adjuvant is necessary to guide. We activate the innate immune adjuvant
Agonist to Toll-like receptor 3 in the double-stranded RNA (dsRNA) that focused on human safety
Double-strand synthesis has been identified RNA, Ampligen (polyI: polyC 12U) using. An animal model BALB / c mice used, dsRNA examined the effect of the nasal vaccine with adjuvant. Ampligen
By the blood that are specific to nasal vaccination with inactivated influenza vaccine IgG antibodies, viscosity
Membrane secretory IgA antibodies, specific T cell response is induced, was also effective against mutants. Until
How the kite is highly pathogenic avian influenza of low immunogenicity (H5N1) vaccine in the sense of
To protect the dye, clade was also effective against viruses with different mutations. Arsenate from the immune system and
Nasal influenza Wa non-human primate experiments in cynomolgus monkeys using a cart near
As mice were able to show the effectiveness of Kuching. with dsRNA nasal adjuvant Infurue
Nzawakuchin the inactivated vaccine using the safe thing to mimic mucosal immunity by virus
To induce, can also support the unpredictable emergence of pandemic influenza infection in the local defense
New vaccine technology. This technology is not limited to influenza vaccine, Kosuke mucosa
Can be applied to many infectious diseases and infection.
Hopefully they announce human testing dates.
Thanks for the post.
GLTA
As I understand it, an Adjuvant used with a Vaccine will give you a twofold benefit:
1) It can increase the total number of units manufactured
2) It can provide a greater range of effectiveness
Too true. Bet the Big Pharmas are quietly approving the extra long delay. You just know they didn't like it when HEB got it's funding in place to operate.
4 months delay after stating 1-2 weeks is very sad indeed.
News recap & opinion from SmallCaps.US
http://smallcaps.us/blog/?p=351
Hemispherx Expands Its Manufacturing Facilities
by admin on September 19, 2009
We also received positive news from our biotech stock Hemispherx Biopharma (HEB – $2.05). The Company will spend up to $4.4 million for engineering studies, capital improvements, system upgrades, and introduction of building management systems to enhance production for Alferon N and its two experimental therapeutics Alferon LDO and Ampligen.
These investments will bring the capacity of Hemispherx’ manufacturing site in New Brunswick in alignment with the projected commercial supply forecast for both Alferon LDO and Ampligen indications to serve markets for up to three years post approval.
Is this good news? We believe so. We feel it means HEB is pushing aggressively to move the clinical trials forward and secondly it means, if anything, the company hasn’t heard to many negative comments from the FDA about the potential approval for Ampligen. And yes, Dr. Carter said on the Rodman conference he hadn’t been in contact with the FDA for quite some time, but that doesn’t mean other people like Dr. Strayer, HEB’s medical director, haven’t been in contact with the agency.
This is why we supported HEB’s public offerings a few months ago, as the Company now has the money to spend on critical items.
_____________________________
The fact is Dr. Strayer is who the FDA contacts at HEB.
GLTA
HEB Long
Maybe Yoshi Mizuta, President of Sage Japan can help shed some light on the subject.
Anyone know the email address for him or the Headquarters for Countermeasures Against Influenza A (H1N1) in Tokyo?
Hope Japan is testing with Ampligen. Their next step was to start the human trials.
Thanks for the update.
Sure would be nice to get a PR by 4 today.
GLTA
You're right, the manufacturing questions were addressed.
The delay has nothing to do with those facilities.
I think AF works entirely too hard to report a bs opinion.
GLTA
HEB Long