Ampligen gets a boost from the PTB's

[George]

Check this out! One treatment protocol coming up! Woof

Hemispherx Biopharma Receives Therapeutic Discovery Project Grant From U.S. Department of Treasury
Covers Therapeutic Applications of Two Technology Platforms


PHILADELPHIA, Nov. 10, 2010 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE Amex:HEB) announced today grant awards totaling $488,958 from the U.S. Department of Treasury in support of its Ampligen and Alferon development programs. These awards were approved by the Internal Revenue Service (IRS), in conjunction with the Department of Heath and Human Services (DHHS), under the Qualifying Therapeutic Discovery Project Program, established under the Patient Protection and Affordable Care Act of 2010 for projects that showed significant potential to produce new and cost-saving therapies, support jobs and increase U.S. competitiveness. The amounts granted for these two Hemispherx projects were for the maximum per-project amount set by the IRS based on the limited amount of funds allocated for the program.*

The Hemispherx Alferon program grant application was based on the potential to show Alferon N Injection, an FDA-approved treatment for refractory HPV, and Alferon LDO (low dose oral), an experimental formulation, to be an efficacious and inexpensive preventative or treatment for seasonal and pandemic flu.

The Hemispherx Ampligen grant application was based on the continuing development of Ampligen (an experimental therapeutic with broad spectrum antiviral properties) in clinical programs in Chronic Fatigue Syndrome, (CFS) and as an adjuvant for seasonal / pandemic influenza vaccines and cancer immunotherapy.

About Hemispherx Biopharma

Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx' flagship products include Alferon N Injection (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics Ampligen and Alferon LDO. Ampligen represents experimental nucleic acids being developed for globally important debilitating diseases and disorders of the immune system. Hemispherx' platform technology includes agents for potential treatment of various severely debilitating and life threatening diseases. Hemispherx has an extensive number of patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection). The Company wholly owns and exclusively operates a GMP certified manufacturing facility in the United States. For more information please visit www.hemispherx.net.

Information contained in this news release, other than historical information, should be considered forward-looking and is subject to various risk factors and uncertainties. For instance, the strategies and operations of Hemispherx involve risk of competition, changing market conditions, change in laws and regulations affecting these industries and numerous other factors discussed in this release and in the Company's filings with the Securities and Exchange Commission. Any specifically referenced investigational drugs and associated technologies of the Company (including Ampligen and Alferon LDO) are experimental in nature and as such are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials with the referenced disorders. The forward-looking statements represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements. *Neither the decision by the IRS to approve the grants described above, nor the planning, completion, results or submission of clinical trials imply that any development project will be successful or that any study product will ever be approved commercially for the studied or other treatment indications.

CONTACT: Hemispherx Biopharma, Inc.
Company/Investor Contact:
Dianne Will
518-398-6222
ir@hemispherx.net

 

[LaurelW]

Thanks, George! Does this mean that they will actually get around to doing clinical trials?:Sign Please:

 

[George]

Well, I honestly expect that there may well be approval late next year. As for Trials HEB has done trials since 1994 and completed Phase III for sure I'm not sure about Phase IV or V. They have asked for FDA approval twice and been turned down. There was a rumor that the FDA turned them down because they "couldn't approve a drug without a disease". The willingness of the latest CFSAC to really pound on the FDA ex-officio and now this leads me to believe that this drug has been fast tracked for CFS and we may well see an approval by the end of next year.

It would make the DHHS look really good to be able to provide treatment to millions of Americans only months after announcing "oh BTW it's ME/CFS and it's caused by a retrovirus" (gotta grin on that senerio)

Plus, I just thought about this, can you see us trouping in to our local clinics and hospitals for our twice weekly IV? Talk about people taking us seriously, the image makes me laugh in my head, takes too much energy to laugh out loud. (big grins)

Hey weren't you in one of the trials???

 

[mojoey]

i think the official reason for turning down the phase III was that they didn't demonstrate enough evidence of safety. But I think George's reason is better

The bigger concern is that it's been almost a year since hemispherx received their CRL (complete response letter) from the FDA, and apparently they have yet to meet with them to discuss it. They have plenty of cash on their balance sheet, so it's not like this extra 500k is what they were waiting for to address the FDA's issues. Some suspect that they are not eager to get FDA approval in the states and are instead looking for opportunities in other countries, but that's just speculation too. The only locked-and-loaded licensing agreement has been the with GP Pharm in Argentina.

Also, keep in mind that 2923 biotech companies received funding from this HHS grant.

IMO the only chance this company has any real chance at getting approved anytime soon is if it gets bought out by one of the big players (Abbott, GSK etc) This is one of the least efficient, terribly-managed companies in existence. They suffer from corporate ADHD and a CEO who few seem to have respect for. To think that our hopes for successful treatment rely on them to any degree at all makes me sick to my stomach.

 

[Sasha]

IMO the only chance this company has any real chance at getting approved anytime soon is if it gets bought out by one of the big players (Abbott, GSK etc) This is one of the least efficient, terribly-managed companies in existence. They suffer from corporate ADHD and a CEO who few seem to have respect for. To think that our hopes for successful treatment rely on them to any degree at all makes me sick to my stomach.

Do you think we ought to be writing to GSK etc to tip them off?!

 

[George]

i think the official reason for turning down the phase III was that they didn't demonstrate enough evidence of safety. But I think George's reason is better

ar, ar, ar, snort! Yeah I was surprised that the rumor stayed alive for quite awhile.

The bigger concern is that it's been almost a year since hemispherx received their CRL (complete response letter) from the FDA, and apparently they have yet to meet with them to discuss it. They have plenty of cash on their balance sheet, so it's not like this extra 500k is what they were waiting for to address the FDA's issues. Some suspect that they are not eager to get FDA approval in the states and are instead looking for opportunities in other countries, but that's just speculation too. The only locked-and-loaded licensing agreement has been the with GP Pharm in Argentina.

I'm impressed, you have really kept up on these guys. I was hoping since they were at least talking to WPI and presenting at the 1st annual XMRV conference that perhaps they were getting serious.

Also, keep in mind that 2923 biotech companies received funding from this HHS grant.

IMO the only chance this company has any real chance at getting approved anytime soon is if it gets bought out by one of the big players (Abbott, GSK etc) This is one of the least efficient, terribly-managed companies in existence. They suffer from corporate ADHD and a CEO who few seem to have respect for. To think that our hopes for successful treatment rely on them to any degree at all makes me sick to my stomach.

Great facts mojoey, thanks for sharing that tidbit. Still less than 3000 and HEB is one of them gives me a tiny sliver of hope. Although I do agree with you in that it is the worst run company on the planet. (big grins) Now if they get bought out or taken over then we would know for a fact that big Pharma is on board and ready to take over. Which would lead to shock and awe amoung the MD set. (snicker grins)

Well, here's hoping.

 

[LaurelW]

Yeah, I was in the phase 3, George. I've really been hoping that they will get bought out by a big drug company and be run better.:tongue:

 

[George]

Maybe Sasha's right and we should start a letter campaign to get one of the big pharma companies to buy them out or up. Anybody know the feasibility of that???

 

[floydguy]

Yeah perhaps big pharma could run around behind the scenes and promote it as an off label solution....

http://www.bizjournals.com/boston/news/2010/11/09/lawyer-charged-with-obstruction.html

 

[mojoey]

It'd probably make sense to target companies that don't have a huge stake in HIV drugs. I find it hard to believe GSK would care to spend 32 mil (although that is chump change to them, so maybe they would) on one immune modulator when they can start testing their ARVs by their lonesomes in clinical trials.

 

[George]

ar, ar, ar, snort Floydguy, that was about par for the course these days. And what about the docs that get in mondo trouble for prescribing off label. (roll eyes)

Good point Mojoey, any pharma that has HIV drugs on the shelf is not going to be interested in Ampligen being added. Ampligen wouldn't really be a treatment anyway since it would only boost NK cells and boost immune response without really targeting the virus itself. I was thinking that the DHHS might be looking at using it as an interim therapeutic until clinical trials could be arranged for ARV's. That would be a great PR strategy. Something that was never available with HIV. If they can say they have a treatment strategy right away it would make people emmmm... not take it too seriously ya know? "Oh hey we found a new retrovirus, it's not as bad as HIV but it does make people sick and we have therapy available and more on the way so no worry's mate". That kind of thing could allow this whole thing to be a non event in the public eye.

If they are not thinking about it as a strategy then maybe they should. (grins)

 

[mojoey]

Someone pointed out that hemispherx actually received no grants in 2010, but instead this is old news from 2009. Check this out: http://www.irs.gov/businesses/small/article/0,,id=229011,00.html

Add up the amounts of the grants awarded to hemispherx in 2009 and you get $488958 which is the amount they announced in the article.

Seeing as hemispherx is the source of the PR release, is it then true that they lied or at least were being misleading by announcing old news as new news? In which case I wouldn't be at all surprised.

 

[George]

By mojoey I think you're right!!!!!!!!!! Egads!!!!!!!!!!!! We will never see the benefits of Ampligen!!!!

 

[heapsreal]

If ampligen affects interferon then it could possibly reduce the reconstitution syndrome from anti-retro drugs, alpha and beta interferon have anti-inflammatory effects against viral inflammation.

ar, ar, ar, snort Floydguy, that was about par for the course these days. And what about the docs that get in mondo trouble for prescribing off label. (roll eyes)

Good point Mojoey, any pharma that has HIV drugs on the shelf is not going to be interested in Ampligen being added. Ampligen wouldn't really be a treatment anyway since it would only boost NK cells and boost immune response without really targeting the virus itself. I was thinking that the DHHS might be looking at using it as an interim therapeutic until clinical trials could be arranged for ARV's. That would be a great PR strategy. Something that was never available with HIV. If they can say they have a treatment strategy right away it would make people emmmm... not take it too seriously ya know? "Oh hey we found a new retrovirus, it's not as bad as HIV but it does make people sick and we have therapy available and more on the way so no worry's mate". That kind of thing could allow this whole thing to be a non event in the public eye.

If they are not thinking about it as a strategy then maybe they should. (grins)