Peregrine Pharmaceuticals (PPHM): Recap of Steven King’s TARVACIN-VIRAL talk at Rodman

Upgrade Today! Level II Pinks & OTCBB from only $29.99

Listed & Nasdaq | Biotechs | Peregrine Pharmaceuticals (PPHM)

Public Reply | Private Reply | Keep | Last Read

Posted by: cjgaddy	Date: Sunday, June 19, 2005 3:54:05 PM
In reply to: None	Post # of 55981

Recap of Steven King’s TARVACIN-VIRAL talk at Rodman & Renshaw’s Security Conference in NYC 6-15-05, graciously provided by JazzBeerMan...
Audio replay: http://www.peregrineinc.com/video-content.php?id=181

By: jazzbeerman 6-16-05 RB #172494:
“Wow. Great talk, great info. Personally I'm glad he spoke the way he did. JMO, but I'd rather not hear a salesman type pitch, but rather facts, just as SK presented them. Re: viral bio-terror threats:
NIAID says broadest testing (multiple viruses) ever with a single agent.
Animal rule: combining good preclinical efficacy data + good human safety data in P1, then you can go directly for the approval process.
They've got the animal efficacy, and the govt is getting more, as apparently Tarvacin has worked on every virus tested so far. Human P1 safety data will be determined from the 2 approved trials, (cancer & HCV).”

By: jazzbeerman 6-17-05 RB #172658 [with tweaks by cjgaddy]:
SK's Tarvacin Presentation - some of my notes...
Received FDA approval for P1 for any cancer including; lung, pancreatic, breast, liver, others in which we demonstrated very significant pre-clinical anti-tumor activity.
Viral Therapy: Filed IND for Hep-C, received approval, initiating trial.
Bio-defense: Tarvacin as a means to stop widespread outbreaks of viral infections (SARS, Avian Flu).
(Scary flu data stats....) - control of widespread pandemic viral outbreaks
Tarvacin recognizes a stable target common to all enveloped viruses. [cannot be easily mutated because it’s derived from the host]
Enveloped virus examples: Marburg, Lassa, Ebola, HIV, HCV, Influenza.
In pre-clinicals, Tarvacin has shown the ability to arrest development of disease even at late stages of infection
We fully expect that Tarvacin can recognize all viruses in the CDC’s ClassA watchlist, like Lassa, Yellow Fever, West-Nile, Marburg
Tarvacin will be effective against viruses that don't even exist yet due to the MOA
For every virus we know about there are hundreds we don't know about. [per Virologist Dr. Dan Bosch]
Tarvacin MOA speil:
3 Tarvacin mechanisms: 1) removes viruses from circulation, 2) traps viruses inside cells, 3) alerts immune system to attack viral infection
"AS A SUMMARY OF THE PRECLINICAL DATA THAT WE'VE GENERATED TO DATE, WE'VE FOUND THAT TARVACIN RECOGNIZES MULTIPLE ENVELOPED VIRUS STRAINS, IN FACT, EVERY ENVELOPED VIRUS STRAIN WE'VE TESTED TO DATE. THIS DATA WILL BE PRESENTED NEXT WEEK AT BIO 2005."
ALSO SHOWN TO RECOGNIZE INFECTED CELLS FROM EVERY ENVELOPED VIRUS STRAIN.
Lassa guinea pig info:
"WE'VE ALSO SEEN EVEN MORE SIGNIFICANT ANTI-VIRAL EFFECTS IN OTHER ANIMAL MODELS, AND AGAIN THAT DATA WILL BE PRESENTED AT THE BIO CONFERENCE NEXT WEEK."
Animals retreated are permanently immune to further infection.
Tarcavin/Viral program going in 2 directions:
1) BIODEFENSE - Bioterrorism & Widespread Outbreaks (animal data + human safety data is sufficient for approval)
2) COMMON VIRAL APPLICATIONS – have collected HEP-C animal data, and are continuing animal studies on HIV & Influenza, ID’ing others
Combine the animal data with human safety data from HCV & cancer trial for relatively rapid approval for widespread viral outbreaks. (animal rule).
History: 11-03: UT-SW studying Tarvacin for ClassA Viruses under NIAID $1.68mm grant; 4-05: NIAID/PPHM agreement to screen Tarvacin for broad-spectrum of enveloped viruses (2 NIAID categories: Health & Bioterrorism)
It really sounds to me like PPHM and the gov’t are doing some of influenza testing, and Tarvacin is in line if proven safe in humans to eventually be a frontline treatment for flu pandemics. I expect to hear influenza data at next week's conference!
In addition, we are developing Tarvacin for common viral applications. There, we've collected data on HEP C virus, we're continuing studies with HIV, influenza, and we're looking at some other potentials there. We will then complete human trials for each of those virus types (fast track obviously for HIV etc) "a more standard route to FDA approval"....
Also, Peregrine is currently in discussions to treat viral diseases in primates, like Marburg, Ebola.
"We have current collaborations with NIAID that are underway to screen against viral bio-terrorism and health threats. This is quite an extensive list of viruses they're testing the drug against. In fact, their indication to us was that this is one of the first times they've ever tested such a broad spectrum of viruses with a single agent."

By: jazzbeerman 6-19-05 iHub #2429:
Steve King quotes from his 6-15-05 Rodman bio-defense speech:
(These are what stood out to me. I have left out info on various supporting material related to disease pandemics, and a lot of info regarding the Tarvacin mechanism of action, as I think most are familiar with how it works and how broad it's potential is for treating both all cancers and all enveloped viruses, (not to mention non-enveloped viruses, bacterial infections, and also parasitic infections, according to other Thorpe patent applications, but that is a topic for another day )... I highly recommend all who are interested to have a listen to King's talk. It's only 18 minutes, and it's right here:
http://www.wsw.com/webcast/rrshq6/pphm/ . . . Steve King:

...."We believe we have an agent that has the potential to have some broad utility in the bio-defense area, whether it's bio-terrorism or in the control of widespread viral outbreaks."

...."Tarvacin recognizes a stable target common to all enveloped viruses that cannot easily be mutated because it is derived from the host, it's not encoded by the genome, but rather it's a stable structure of the virus particle. Examples of enveloped viruses include marburg virus, lassa fever, ebola, HIV, Hepatitis C, influenza. Secondly, as I'll show you later in some preclinical data, Tarvacin has shown the ability to arrest the development of disease even in late stages of infection. And thirdly, Tarvacin is expected to recognize not just the known enveloped viruses that are here today, but new enveloped viruses that will undoubtedly become available and will have mutated and become new viral strains over the next years to come."

"This is an example of the enveloped viruses that are on the class-A watch list from the CDC. You can see the viruses that are on here such as lassa fever, yellow fever, west nile virus, marburg virus...., and the reason I put this up here is that we fully expect that Tarvacin would be able to recognize all of these viral types, not just individual viruses where we'd have to develop new agents for each virus, but rather a single agent that could recognize all of these.".....

...."As a summary of the preclinical data that we've generated to date, we've found that Tarvacin recognizes multiple enveloped virus strains. In fact- every enveloped virus strain we've tested to date. This data will be presented next week at Bio 2005."

Secondly, Tarvacin recognizes virally infected cells from multiple virus types. This again has been shown in a number of systems and we're continuing those studies, and so far in every system we've looked at we've seen the expression of the Tarvacin target on these virally infected cells.

Thirdly, Tarvacin has shown activity in the treatment of animals infected with lethal doses of lassa fever which is a ClassA bio-terrorism watchlist virus.

We've also seen even more significant anti-viral effects in other animal models, and again that data will be presented at the bio conference next week."

"Our plans for developing the Tarvacin antiviral program are really going in two different directions. The first is really geared toward bio-defense applications, so this could be either bioterrorism applications or widespread viral outbreaks. Our priority is to generate preclinical data. As the previous speaker mentioned there's really no way to run clinical trials for many of these bioterrorism threats, so collecting preclinical data is really about the best you can do. We then want to combine that with human safety studies that we will be generating in the Hepatitis C clinical trial, as well as our anti-cancer clinical trial, and we believe, pending positive results of course, that this could be a fairly rapid route to regulatory approval for Tarvacin for the treatment of- again- widespread viral outbreaks.

In addition we are developing Tarvacin for common viral applications. There, we've collected preclinical data on hepatitis C virus, we're continuing studies with HIV, influenza, and we're looking at some other potentials there. We will then complete human clinical studies for each of those viral types, again- our hepatitis C clinical trial should be beginning soon, and we'll initiate new clinical trials as appropriate in timelines and of course this is what I would call a more standard route to regulatory approval"

"In April of this year, Peregrine and NIAID entered into an Agreement to screen Tarvacin for activity against a broad spectrum of enveloped viruses, and these really fall into two categories- those of health concern, and those of bio-terrorism concern.".

"So to kind of summarize why we're excited about Tarvacin in particular for the bio-defense applications:

Number one, we've received promising preclinincal results in the lassa fever animal model. Those included both short-term treatment advantages, as well as long term immunity to the viral infection.

The second is we have current collaborations with NIAID that are underway to screen against viral bio-terrorism and health threats. This is quite an extensive list of viruses they're testing the drug against. In fact, their indication to us was that this is one of the first times they've ever tested such a broad spectrum of viruses with a single agent.

Thirdly, discussions are taking place to screen Tarvacin for activity against additional bio-terrorism and health threats again these would fall under the marburg and ebola virus families.

Fourth, data from preclinical human phase one safety could be used to support expedited FDA approval as a therapy for bio-terrorism and health threat concerns, and this kind of falls under the animal rule which was recently enacted and implemented by the FDA, in which if you can combine good preclinical efficacy data along with good human phase one safety data, then you can effectively go directly for the approval process.

Fifthly, the mechanism of action and target indicates potential as a single agent that can be effective against a wide number of enveloped viruses, including those that are known about and those that are not known about,

And, lastly, human clinical studies are not far away. They will be beginning over the short term. This will provide us with critical, number one, safety data for the program, which will be necessary for any future approval filings, but also, in those same clinical trials we'll be looking for the effectiveness of removing the hepatitis C virus by looking at viral load changes."....

Steve King, president/CEO – compiled by JazzBeerMan

= = = = = = = = = = = = =
Other Commentary from Posters:

By: pphmtoolong 6-15-05 RB #172391:
“King may not be an exciting speaker, but did you catch his noting that the Tarvacin target was present on every enveloped virus they had looked at? Did you also catch that the NIAID noted that they had never had a drug that they wanted to test against so many different viruses? Did you also note that King said the FDA has provisions to approve certain drugs that show strong pre-clinical effectiveness coupled with Phase I evidence of safety? Also, did you note that new Tarvacin anti-viral testing information would be released at the BIO 2005 conference next week? His delivery wasn't that inspiring, but the content of his talk worked for me. The audience found the presentation worth a fair amount of applause; let's hope they go out and buy some stock.”

By: EZLibra 6-16-05 iHub #2392:
“Finally, I have heard the whole thing. Outstanding, what an information overload! Successful testing on West Nile, SARS, Yellow fever, Hepatitus C, HIV, flu, Marburg, ebola, Lassa fever...every enveloped viral strain we have tested...all virally infected cells we have seen have had the Tarvacin target...(talking about viral pandemics)hundreds that we don't know about. Results being presented next week at BIO 2005 are 'more significant than we saw in Lassa Fever.' ...treatment subsequently infers immunity. Bioterror threats, preclinical and human safety data put us on road to regulatory approval. Animal Rule. NIAID says '...one of the first drugs ever to target such a broad spectrum with a single agent.' Tarvacin is just a one mg dose. I look at my jars of pills - here's one for 500 mg (thrice daily), another for 300 mg, etc. Heck, just weaponize Tarvacin, load it on a few cropdusters, find some jungle 'island' with a hemorrhagic virus gone wild and envelop it.”
Followup: “They have toxicity data from the fourteen different primates tested for the cancer trial so for the viral indication they go right into IB/II for a safe, effective/practical tolerated dose. This would be for HCV and, if successful, would roll right into HIV, HPV, Yellow Fever, SARS, avian flu, et cetera. For the hemorrhagics they go right into dosing infected primates - doesn't matter who takes credit as long as it's Marx/Smith calling the shots, so to speak. I think you're right about Lassa Fever - by this time they should have scaled up the testing from the guinea pigs.”

By: jazzbeerman 6-17-05 iHub #2405:
re: "PPHM is using one dose in the protocol, if it yields a drop of 1log in viral load and there are no harmful side effects observed with this one dose....then the FDA should let PPHM move into a Phase Ib dose escalation study fairly quickly.....it's also apparent that the safety data generated will be used to support an NDA for perhaps some biothreat indications...."
According to my understanding, PPHM is using 1 infusion per patient, but a range of doses (does escalation) in this very first study. (!)
And yes, SK came right out and said it- safety data from this study, (if it's good) and animal efficacy for biothreat viruses, (which we will apparently learn more about next week), will be used for NDA's! for Lassa, Marburg, etc, etc, etc,.. It could happen very fast with this animal rule. Tarvacin is the perfect thing (according to the preclinical data) to soar through the animal rule- for the broadest indications of any antiviral drug ever. We are very close to potentially big news that would actually make news, news for average Americans who have never heard of Peregrine or Tarvacin before. But of course I'm preaching to the choir here ;) All it will take is safety data from the HCV trial... then - BAM.

By: mskatiescarletohara 6/15/2005 IHub #2383:
“Did anyone catch the reference to 'ongoing discussions' regarding primate studies? I interpret that as meaning PPHM is negotiating primate testing for indications from the bioterrorism list with the government. Perhaps the government is going to test the primates... Also, SK stated safety data from oncology and the Hep-C phase I studies would be very important because the data would be used to support expedited approval of indications which are perceived to be bio-threats. He's referring to the 'animal rule' clause, the FDA allows solid pre-clinical data from animals, primates and safety data from Phase I studies. I also heard SK state that the safety data from Hep-C would be used to support further viral INDs, i.e. HIV, Hep B and Influenza. Last but not least, MORE pre-clinical viral data from various systems will be presented next week at BIO 2005, (this was what I was hoping for...weeeeeee!)...also he said they would present data next week with "even more significant anti-viral effects in other animal models"... Short term treatment combined with long-term immunity is going to be a BLOCKBUSTER in the viral field.”
Followup: “Anyone here think PPHM could cut a deal similar to the deal CRXL negotiated with the NIAID/NIH/VRC? Crucell didn't have the in-house expertise to test the compound for viral challenged studies as mentioned in the below PR. I'm quite intrigued with SK's statement about ongoing primate discussions... Would Preston Marx and Stephen Smith conduct the primate studies for PPHM at the Tulane facility?”

By: mskatiescarletohara 6-16-05 IHub #2388:
“I thought SK gave a thorough overview of the viral program yesterday. I could understand him, he was clear and concise in his message regarding Tarvacin, he's a scientist, not a preacher! PPHM needs SK at the helm to market Tarvacin to the investment community. Maybe I'm reading too much into his statements, however, IMO, he all BUT stated 'we're in talks' with the gov about a future deal or contract for Lassa and other VHFs. They are discussing primate testing and making references to the animal rule? Hello? These folks are doing their homework, the NIAID, Marx and Smith are making it happen, can ES, SK , PL and the other players close a decent deal? Can AVID house a 10K bioreactor? If PPHM is successful in getting a manufacturing contract with the gov, they'll need to upgrade...”
Followup: “+++What are the pros/cons with treating sick people phase 1 to demonstrate safety? They can further prove proof of concept should any efficacy be observed, and they can get a lead on determining MTD, or optimal dosing...the cons are undesirable side effects, and no efficacy. I don't think a lot of folks have caught on to what's cooking behind the scenes with this Hep-C IND... PPHM is using one dose in the protocol, if it yields a drop of 1log in viral load and there are no harmful side effects observed with this one dose. Then the FDA should let PPHM move into a Phase Ib dose escalation study fairly quickly. It's also apparent that the safety data generated will be used to support an NDA for perhaps some biothreat indications.”

By: jazzbeerman 6-18-05 RB #172710:
Katie, re: "shown the ability to arrest development of disease even at late stages of infection"
I agree, a very important statement. My thoughts on that…
In the only animal viral efficacy data I'm familiar with, Thorpe, PL, & SK have all mentioned repeatedly how sick the guinea pigs were at the time of Tarvacin treatment. They let them go very far with the infection- they had lost weight, they had super high fevers, their fur was visibly affected etc.. It may be that they were on the brink of absolutely nothing being able to save them. Tarvacin saved half of them, who went on to be immune to further infection, and to lead normal lives, (until I assume they killed them)...
It may be (I'm figuring) that in further experiments they've generated much better statistics on Tarvacin than this first study, which in itself was unprecedented and obviously very impressive, (according to the NIAID). I think we'll be seeing numbers closer to 100% in animal studies with the animals doesed with Tarvacin less closer to death, dosed soon after infection with fewer or no physical signs of infection, OR possibly- studies to demonstrate immunity by dosing before infection, (however short-lived it may be, or not), and further tests into how long immunity to any enveloped virus lasts after "inoculation".
The company has stated it is interested in finding out whether treatment with Tarvacin for one enveloped virus confers ant immunity to other enveloped viruses. I think it's a good question, and leads to another question-
If so, then couldn't people be 'inoculated' with a 'simultaneous shot' of Tarvacin combined with a harmless enveloped virus (as if we don't all have one or two floating around our bodies already, like HS1 etc.) ??
I'm sure the govt. is investigating many angles, including not only therapeutic treatment after infection but also as a possible vaccine, and if so, due to the mechanism of action, this admittedly increasingly hypothetical vaccine would be for all enveloped viruses.
As I said, I look forward to next weeks data!
- - - - - - - - - - - -
SK says,
"AS A SUMMARY OF THE PRECLINICAL DATA THAT WE'VE GENERATED TO DATE, WE'VE FOUND THAT TARVACIN RECOGNIZES MULTIPLE ENVELOPED VIRUS STRAINS, IN FACT - EVERY ENVELOPED VIRUS STRAIN WE'VE TESTED TO DATE. THIS DATA WILL BE PRESENTED NEXT WEEK AT BIO 2005. "
ALSO SHOWN TO RECOGNIZE INFECTED CELLS FROM EVERY ENVELOPED VIRUS STRAIN.
"WE'VE ALSO SEEN EVEN MORE SIGNIFICANT ANTI-VIRAL EFFECTS IN OTHER ANIMAL MODELS, AND AGAIN THAT DATA WILL BE PRESENTED AT THE BIO CONFERENCE NEXT WEEK."
"We have current collaborations with NIAID that are underway to screen against viral bio-terrorism and health threats. This is quite an extensive list of viruses they're testing the drug against. In fact, their indication to us was that this is one of the first times they've ever tested such a broad spectrum of viruses with a single agent."
- - - - - - - - - - - -
IMO, the inoculation pre-infection angle is a biggie, even if the immunity only lasts a relatively short time, as it will have huge implications for influenza, (if safe in humans and we'll know soon) . Just absolutely huge I say, and with the animal rule it can (AND WILL- IF SAFE IN HUMANS) go from animal efficacy + human safety to NDA for influenza (read avian flu) outbeaks.
How many times did King mention Tarvacin as a means to stop 'widespread outbreaks of viral infections' ?
His whole intro was on historic flu pandemics.
I think they've got some good flu data. We'll see.

By: jazzbeerman 6-18-05 RB #172725:
Steve King: “Tarvacin recognizes multiple enveloped virus strains. In fact, every enveloped virus strain we've tested to date. This data will be presented next week at BIO2005… We've also seen even more significant anti-viral effects in other animal models, and again that data will be presented at the Bio conference next week… We have current collaborations with NIAID that are underway to screen against viral bio-terrorism and health threats. This is quite an extensive list of viruses they're testing the drug against. In fact, their indication to us was that this is one of the first times they've ever tested such a broad spectrum of viruses with a single agent."
--------------
Let's see now........
It's worked on every enveloped virus strain they've tested, finding both the viral entities and the infected cells- in every enveloped virus they've tested. The NIAID remarked about treating such a broad spectrum of viruses with a single agent.
It has also shown to be VERY safe in animal preclinical data, including guinea pigs, mice, rats, and 14 species of monkeys, which incidentally had to be given 10 or more times the estimated effective dose before they started noticing any mild side effects. The data showed such safety that the FDA has given the go-ahead for 2 trials, in all solid tumor cancers and HepC in what amounts to more of a Phase 1b type study in each trial. All that is needed to satisfy the "animal rule" for many viruses (that can not be ethically investigated in humans when there is no present case of outbreak) is animal efficacy and human safety. The animal efficacy is looking quite strong, and the i's will be dotted and t's crossed through extensive testing by NIAID. The human safety data will be gathered from both the cancer and viral trials, getting underway. (The animal rule would apply to West Nile, Ebola, Marburg, Avian Flu, Lassa,...)
How many doses of an effective flu treatment would the US (or the WHO) like to have on hand to feel safely prepared for the next imminent deadly flu pandemic?...
Important fact to remember regarding Tarvacin manufacturing: Tarvacin is manufactured by Peregrine’s subsidiary, Avid Bioservices, using a CHO cell line grown in suspension. Rich Richieri, Avid’s VP/Mfg, says that all materials used in the process are animal-free, and that the purification uses standard, generic protein A-based chromatography followed by ion-exchange polishing steps. “One of the things we wanted to do at Avid was create a process that is scalable, so that if Peregrine were to scale up at Avid, or go with a corporate partner or another facility where they had 5,000-liter tanks, this process could be easily adapted to those systems,” he explains. Using well-known processes and off-the-shelf materials should also help FDA’s “comfort level.”

By: jazzbeerman 6-18-05 RB #172733:
Steve King: "Our plans for developing the Tarvacin antiviral program are really going in two different directions. The first is really geared toward bio-defense applications, so this could be either bioterrorism applications or widespread viral outbreaks. Our priority is to generate preclinical data. As the previous speaker mentioned there's really no way to run clinical trials for many of these bioterrorism threats, so collecting preclinical data is really about the best you can do. We then want to combine that with human safety studies that we will be generating in the Hepatitis C clinical trial, as well as our anti-cancer clinical trial, and we believe- pending positive results of course- this could be a fairly rapid route to regulatory approval for Tarvacin for the treatment of, again, widespread viral outbreaks."

= = = = = = = = = =
6-8-05 PR: http://ir.peregrineinc.com/phoenix.zhtml?c=74236&p=irol-newsArticle&ID=718222
Audio replay: http://www.peregrineinc.com/video-content.php?id=181
June 8, 2005: CEO Steven W. King, will present a company update primarily focused on Tarvacin's anti-viral potential to combat a number of "enveloped" and potentially lethal viruses at the Rodman & Renshaw Techvest 2nd Annual Security and Connectivity Investor Conference. The live presentation is scheduled at 4:35 p.m. EDT on Wednesday, June 15, 2005 at the St. Regis Hotel in New York City. The Conference is featuring Tom Ridge, the Former Secretary of Homeland Security, as a keynote speaker.

Peregrine Pharmaceuticals (PPHM) Stock Trading Info:

Public Reply | Private Reply | Keep | Last Read

Next 10 | Previous | Next

Add Peregrine Pharmaceuticals (PPHM) To Favorites

Keyboard Shortcuts

Report TOS Violation


Current Price
Change
Volume
Detailed Quote - Discussion Board

+/- to Watchlist

About Us | User Agreement |

Site Map & FAQs | Contact Us | Advertising | New Stuff Blog | Stock Market 101