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Decided to look at my Smith Barney statement today, the "deemed high risk, money to lose" portfolio. I still have some PPHM stock and its up from three years ago! Wow. I sold off a lot of my biotech stocks when the economy started tanking and decided to take a break.
Any partners yet?
If they would have tried to send up a fluff b.s.
LOL LOL LOL LOL LOL!
You Mr. Lkkr. The Lackest of All is sitting at .39 cents.
LOL. You have been had by those PR FLUFFIES! How does it feel to be licked by PPHM?
Your friend, Katie...Merry Christmas!
Trimeris sets departure date for leaders
Thursday October 11, 4:45 pm ET
Trimeris' top executives, temporary consultants brought on to turn around the drug company after its previous executives left, will leave the Morrisville concern Jan. 2.
E. Lawrence Hill, president and chief operating officer, and Daniel Ratto, chief financial officer, joined Trimeris earlier this year after former CEO and co-founder Dani Bolognesi and CFO Robert Bonczek were asked to resign from the company, which has developed an AIDS drug known as Fuzeon.
Hill and Ratto are consultants employed by California firm Hickey and Hill. Their job at Trimeris was to prepare the company for human studies of its next-generation AIDS drug, T-1144, said Andrew Graham, the company's director of finance. Trimeris plans to file for permission to start human trials on the drug in the first half of 2008.
"They were hired to do a specific job, and that was to put us in a position to file an (Investigational New Drug Application) for 1144, which they've done," Graham said. "... It's nearing the end of the time when they can add value to the company."
Still at question is whether any development can add value to Trimeris at this point.
Bolognesi and Bonczek left the company at the end of a trying 12 months that saw sales of Fuzeon come in below expectations. Also leaving were dozens of employees, who lost their jobs as a cost-cutting measure.
At the same time, the company lost the support of its drug development partner, Swiss company Roche, for T-1144.
Meanwhile, Pfizer won U.S. regulatory approval for a new AIDS drug known as Selzentry. And Merck is seeking this week approval of an AIDS treatment called Isentress. Both could take market share away from Fuzeon, which must be adminstered through painful injections.
Finally, New York investment firm HealthCor has bought nearly 19 percent of Trimeris' shares and has demanded changes. In particular, it wants Trimeris to seriously reconsider plans to develop T-1144, a course of action it calls "too expensive, lengthy and risky," and look into selling the company.
Graham said Trimeris has been in contact with HealthCor.
"The company has had communication, as it would with any large shareholder," he said. "But I'm not going to comment beyond that."
He also said Trimeris has made no decision on who will lead the company after Jan. 2.
"We're taking it one step at a time," he said. "... Right now the board's confident that we have the correct management team in place."
Cannacord's Dorsheimer is negative on this stock. Especially since the stock gained momentum on buyout rumors and regained strength last week. I'm curious to see if CREE will confirm on Dorsheimer's speculative claims the company is seeing pushouts on the upcoming CC and if he will participate in the upcoming call.
Cree, Inc. Announces 2008 First Quarter Earnings Call Webcast
Thursday October 4, 2:29 pm ET
DURHAM, N.C., Oct. 4 /PRNewswire-FirstCall/ -- Cree, Inc. (Nasdaq: CREE - News) announces the following Webcast:
What: Cree, Inc.'s Conference Call
When: October 18, 2007 @ 17:00 (military) Eastern
Where: http://www.videonewswire.com/event.asp?id=42745
How: Live over the Internet -- Simply log on to the web at the address
above. The Webcast will also be available, at the address above,
for replay.
Raiford Garrabrant
Director, Investor Relations
Cree, Inc.
Ph: (919) 313-5397
Fax: (919) 313-5615
Email: raiford_garrabrant@cree.com
Isn't it interesting that Health Cor comes out pumping the company should be sold and then this news hits!
Is the fat lady preparing to sing for TRMS?
It's time for Roche to take over.
katie...
VRUS racemate? I don't know anything about Racivir. Is it a better modified version of Emtriva (FTC)? Triangle Pharma developed FTC (emtriva) as the enhanced version of GSK's (3TC) Epivir, is it (Racivir) a third generation compound of 3TC and FTC?
Epivir was on the market I think in the mid-90's and it was applauded as one of the "the best nuke" drug by the HIV community. It was huge when GSK launched it. I think the CEO of Triangle was working on Epivir when he decided to start his own company, licensing a better version of 3TC from a university in GA., perhaps it was Emory. Triangle wanted to get the drug on the market by 2001, but ran into trouble conducting the pivotals in South Africa.
So, what is a racemate?
With respect to GILD, I don't think they will license it, they have too much invested in the triple combo drug now. It's destined to become the number 1 nuke in the world.
GILD turned their nose up at Pharmasset's Clevudine when they bought Triangle. They were launching Hepsera.
katie...
+++ceo may want to bring in his own people or the underlings take the cue and move on.
Good point! When chief's come in, change usually arrives within a year of their hire....
Let's hope the upcoming data is good and the company can provide a positive update on the tablet formulation.
Interesting TRMS news, Health Cor buys more stock and cheers TRMS should be bought...day later, Roche and TRMS announce they will pull the bioinjector NDA. Fuzeon is on it's way to being shelved in the future, especially if PANC's oral fusion inhibitor gets in the clinic and gets marketing approval years from now. One of the reasons I invested here was for the oral fusion inhibitor program.
katie...
VRUS--Would the FDA consider the Bukwang studies as part of the marketing approval package here in the US?
It appears by 2010 it may be on the market with potential labelling upgrades forthcoming. Wonder how long it will take to enroll the pivotals? Any guidance from management, would one speculate a year?
katie....
Peyton leaving is troublesome. His departure can mean several things. 1) Continuing trouble with the tablet formulation, which means BP interest will continue to slide 2) Raising cash under current circmstances with the PPS and no real clean compelling data will be raised under harsh terms detrimental to shareholders. MAJOR DILUTION. 3) The Phase 2b 300 mg study is delayed, moved out to 4th quarter, that's never good, is it due to enrollment? Wishful thinking...4) Perhaps a buyout offer is on the table pending the 300 mg study and Peyton needs to look for another job.
Still long.
katie...
Van Halen Reunion---Wonder if Dave can still do those high kicks and jumps for "Jump"?
Will let you know soon, my crowd and I are headed to the show in G'boro, NC, Saturday. Have excellent seats just the right of Eddie and above the ramp that curves into the floor section.
Saw Van Halen in summer of '80 at a stadium show, cram packed, they opened for Boston and obliterated them. It was sooooo loud, I'll never forget how loud their sound system was... I was hooked after seeing them live. Never cared for them after Hagar joined.
FWIW, I'm totally psyched to see Roth and Eddie perform again, and even more interesting is Eddie's 16yr old son is playing bass. I think he's the glue that's gonna hold band together, how wild, he's only been playing bass for couple of months.
Roth is looking good better than the pics you posted, Eddie has clearly been through the ringer, yet still playing very well. There are some clips of their rehearsals for this tour on You-Tube.
Ahh the memories, been playing Van Halen I and II all week....loud of course.
katie...
Overhead...after my lesson, (first, of many) we worked on my backhand problem. My posture and stance are all wrong. This was corrected, I'm not bending at the knees enough and am opening the racquet face up too much, thus the balls are going way outside the service line. It's going to take some practice, but, after some serious corrections, my two hand was much better today. I also have been guilty of not stepping in or up to the ball, yet swinging at it. Serve got better too. Amazing what one hour of instruction can do for one's game.
I have the Tennis Channel! Who's playing tonight? And who is on our Team?
katie....
Overhead...Do you normally do stretching, or use the stairclimber or elliptical machine to warm up before you start hitting the ball; I find sitting in the dry sauna for a few minutes, and then start stretching also helps tremendously.
I always consume a good breakfast since I like to play in the morning. Take a banana on ice, and nibble it between changeovers. I also listen to rock music very loud before arriving for my match, it's my psyche. I always stretch before and after playing, especially my arms and legs.
This morning I played someone who IMO is a 3.5, we went 7-6, 7-6, lots of deuces, I lost, but my strokes are coming back, my serve was dead on. I used to have a powerful two-hand backhand, it's not working, so I'm focusing on keeping the ball in play using one hand and avoiding taking shots that are iffy. My two hand is too strong and not landing in the court. Needless to say, I'm a little sore this evening, yet quite pleased with the level of executed shots.
I have a lesson with "Moses" Friday morning. I'm determined to get back in the game.
katie....
Getting back into tennis. Was rated a 4.0 player a few years ago, incurred a painful calf/achilles tendon injury--literally had to be carried off the court. I haven't played much in the last two years, getting back into it now. Playing on a 3.0 ladder this fall, currently, to "find" my serve and shots again, will probably advance up to 3.5 by Winter.
My "Debs" in-training have finally shown an actual interest in learning the game now. I've had them in clinics before where they didn't apply themselves, now that they are older and the eye/hand coordination is more developed they are hitting the ball much better. The foam trainer balls are great for beginners, the frustration level is reduced and they are very enthusiastic about playing "doubles" with other kids their age.
Serena sure showed her ugly side at the Open...didn't she?
katie...
Realist...
As Katie had pointed out this is a small and early piece of a very long range plan for developing a HIV vaccine, which Bavi is not. Duke is just playing around with anti-PS as a possible part of their bigger picture there.
PS is a target scientists have toyed with for years. Just a model. DUKE may, probably are working on their own construct, PPHM/Univ of Tex-SW may get a license deal out of it, HIV vaccines, hell, any vaccine takes years of work in the clinic. I'm still waiting for the LETVIN primate data, was there any mention of it today? Wink.
Nothing new about the gov't contract regarding the (POTENTIAL - still negotiating) $44 million , but they were clear that the Gov't would be telling them exactly how to use it.
My guess is the award will be granted to the Univ of Tex-SW, since it entails preclinical research and the previous awards were granted to that entity.
PPHM's mabs have always worn the POTENTIAL dress for decades.
The Phase II trials....here in the States or in India? Any clarification on that today?
katie...
VRUS---"The R7128 results are exciting based on the combination of potency, safety and tolerability. There were no major organ or other acute toxicities observed during the 14-day dosing period, which is encouraging for future studies with longer exposures to R7128 in combination with the standard of care.
Hence, the upcoming 28 day study in treatment naive patients. Impressive results reported today, not surprising to see Roche moving 'full-steam' ahead. VRUS's CMO sure made a bold matter-of-fact statement too.
katie...
LED ZEPPELIN PRESS CONFERENCE 9-12-07
I get chills thinking about a tour here in the States, not to mention the mega-bucks I would pay to see them. If they regroup just for one show, I hope it gets recorded like the CREAM reunion.
http://www.billboard.com/bbcom/news/article_display.jsp?vnu_content_id=1003637012
Led Zeppelin Announcement Expected Next Week
Led Zeppelin
September 07, 2007, 3:35 PM ET
Ray Waddell, Nashville
Talk of a Led Zeppelin reunion just refuses to go away.
Billboard reported in July that the band may get together for a proposed tribute to the late producer/record mogul Ahmet Ertegun at the O2 in London in November,
Now on Ledzeppelin.com the date 11.13.07 mysteriously appears with the familiar Zep symbols. And several people saw the band touring the O2 during Prince's recent stand at the new 20,000-seat London venue. A press conference next Wednesday (Sept. 12) in London may clear everything up.
There has been talk that tour producers AEG Live and Michael Cohl's CPI (Rolling Stones, Genesis, Barbra Streisand) have put in offers on a Zep tour featuring founding members Jimmy Page, Robert Plant and John Paul Jones with late drummer John Bonham's son Jason on drums. But it is also well known in the industry that standing offers have been on the table for a Led Zeppelin tour for more than a decade.
Nov. 13 also has another significance: it's the release date of a new Atlantic/Rhino two-disc, 24-track best-of set, "Mothership." Additionally, a deluxe reissue of the soundtrack to the 1976 concert film "The Song Remains the Same" with previously unreleased material and a new DVD edition of that movie will arrive Nov. 20 via Atlantic/Rhino and Warner Home Video, respectively.
KT....Gander at the latest PIPE. I haven't read about any deals with BP recently. Have you?
Is BP starting anything here in the States with PPHM or for that matter in India...?
If you are referring to BP interest....well SK and the BOD have stated for years and years that they are interested...so maybe they are...but there is no deal. The company does have a reputation for stating BP interest...but BP never antes up.
katie...
I am very enthusiastic about the science of the company,
Pic...you just stated what SK and the BOD have been stating all along with PPHM's intellectual property. Pharma has not stepped up to ante on Bavi. Pharma didn't step for Cotara, didn't step up for Oncolym.
The company is still conducting (proposing to conduct) half-ass Phase IB studies here and there and in India now. Here in the US, they always start with Phase I. The HCV/Coinfect study...voila Phase I. It goes on and on.
IMO, it's not management's fault the drug is not garnering someone to sign on...it's results. Folks here can scream at the top of their lungs the results are great....but, BP is nowhere in sight.
Is it really the BOD's fault PPHM's mabs are not yielding results which entice BP? No. By golly they have the best SRB'rs on board, that's well documented. The SRB'rs are still working it....some have fled, some are still amongst, some are dangling.
When you have "fled, amongst, dangling and no deal" it equals PIPE. Dilution.
Good luck to your family, appreciate your galliant effort over the past years. The drugs just do not entice BP. IMO. Sorry, but I believe this BOD would sell immediately to the right offer. Any offer at this juncture.
katie....
Hayward.
The HCV program is on life support as another poster point out a couple of days ago.
The "planned" HCV Phase Ib's were talked up and down, all around for the last year and half, hell two years. A new HCV coinfect trial is now part of the grand scheme to determine optimal dosing?
I don't disagree with any of your thoughts. The shorts are gambling Bavi is a bust.
katie...
If Bavi ain't so hot, then why the gov't interest?
It would be great if the govt did award the contract to PPHM! It would represent much needed endorsement for anti-PS program.
It's still pending and it's funding not just for Bavi, but for other anti-PS mabs as well.
katie
To Lurker...thanks for the reply with the updated CC transcript since I missed it.
My thoughts are still the same based on what you posted. BP is not interested, it's odd to me, yet not surprising, the company would use the co-infect study as reason to delay the HCV/SOC trials which were projected to start way over a year ago...a year ago SK was broadcasting to the investment community these trials were cheap to conduct, they'd be small etc., no problem in enrollment and they are not happening. What changed the bullish attitude? The last patient dosed in the Phase Ib HCV trial was last year in Oct. '06. If Bavi was hot for HCV, McHutchison, Lawitz, Godofsky would be enrolling patients right now. Data changed the attitude.
No one knows how to dose Bavi to attain optimal dose and BP isn't interested in investing at least 5 million to figure it out.
A significant R&D change was made in the last year based on the final results from the Phase Ib repeat dose study. Bavi is not being tested in HCV SOC patients today. Just co-infects and more spin to make up for compelling results not attained.
I'm sure the advisors and PPHM's management is pleased, of course they are, they (mgmt) would never publicly state the drug didn't attain the results they were hoping to achieve. Still waiting on the HCV SRB advisors to get "hot" about Bavi.
It appears to be cool, hence dilution and no interest from BP.
katie...
Microbe Man....
Where are the combo trials?? Are they pending (still) or have they been quietly been pushed under the rug?
Under the rug! And quietly I might add. No one here on the thread wants to talk about it or even acknowledge it. Neither did PPHM management on the latest CC from what I hear...
Did you read the acceptance PR regarding final Phase Ib data at AASLD? There was nothing in that PR indicating new HCV combo trials were forthcoming...just we are starting over treating the HCV Co-Infect population.
Cha-ching for Katies Kids,
katie....
Yes, Jakeman, I'm a PAID basher I sit here 24 hrs a day posting about PPHM, culminating a cent for each post that deflates the pumper's dreams into the "FEED KATIE'S KIDS FUND" which is disbursed to those less unfortunate individuals who really need to eat.
Look at my history this summer or better yet my tenure here on this thread. God look at the cents I've raked in thus far.
Go back to the school yard and learn how to play kick ball.
katie...
Steve, 2C3 is another VEGF mab, everyone has one in their pipeline. Remember the Avastin craze a couple of years ago? I had lunch with a VC rep at a bio conference, his statement was there are over 400 VEGF candidates in preclinical since Avastin, BP is bored.
Learning on the job, they are scientists conducting R&D. SK and Crowd have in the past recruited the most reknowned academia to work with Bavi. Ask CJ Gaddy, he has a complete roster of these physicians. Where are the US trials? One enrolling here in the States for HCV-HIV co-infects....what about cancer?
What is extreme about Bavi not entering HCV SOC trials, it's not, management has opted to target another difficult patient population. Management has abandoned HCV SOC trials, none are enrolling after two years of promises they would. Why wouldn't you question that? The cost to conduct HCV SOC trials have skyrocketed with the current competition.
A savvy biotech executive cannot turn PPHM around without compelling data. Doesn't matter if he has 25 years tenure with DNA, BMY, GSK, NVS etc...
I'm not surprised R&R have remained quiet.
katie...
Eac, HCV SOC can be written off, however, co-infect, we shall see what happens there.
Influenza....? Nothing there. Sanofi, GSK, have that under their skin. BCRX just landed a lucrative deal.
HIV....? Duke...don't think there will be a Bavi HIV trial, if the DUKE crowd thought the mab would accomplish wonders, the trial would be enrolling a year ago. Duke views PS as an interesting target, they'll toy with it for awhile and make their own construct.
katie...
Be fair? Re read what you just posted.
That might have a little something to do with no BP stepping forward yet, don't you think?
No data, nyet, no deal. Dilution is the only alternative. The company has YET to deliver any meaningful data to BP, that's the point, no pulse....
Dilution.
katie...
PPHM keeps chugging along with drug candidates, a group of scientists working the petri dishes, animalia, etc., Bavi is the third mab, no one appears to be jumping up and down!
Hence, the dilution.
Radiolabeling didn't yield promises with Oncolym and Cotara for BP. Presently, Bavi is overseas in Asia for Cancer and GMB without FDA endorsement. If the FDA has indeed endorsed the protocols abroad, do enlighten me with a link or verbatim statement from SK stating the protocols are being conducted under their (FDA) jurisdiction.
PPHM has yet to deliver any meaningful data to BP, IMO. Just wanted to be sure all understood the dilution dilemma. No intriguing data, welcome Mr. Pipe.
There you have it. Folks can scream management doesn't know how to close a deal all night and day. Scientists are why biotech exists.
Lesson, no meaningful data. Nothing. Nyet. See ya'll later.
katie...
Dew, I concur. PPHM's Bavi is on life support for HCV, the only shot the mab has is the co-infect population. I don't fault management for pursuing that route, they know they don't have a chance at HCV SOC.
Programs on ‘life support’ (IMO)
R1626 ( Roche )
Celgosivir ( Migenix )
Bavituximab ( PPHM )
Did you decide to reestablish a long position?
No, I did not, although I still have shares that are underwater designated "long" years ago.
Regarding the HCV indication, yes, I'm stating that management has set the HCV SOC indication aside, they clearly are not enrolling any studies right now with HCV SOC, they have opted to pursue the co-infect indication.
Hype about insider trading, R&R still conducting DD, hostile takeover etc is just hot air.
Does Bavi make a difference in patients? That's the real question. Where is the knock out data? Where are the physicians here in the States screaming for Bavi for their patients?
I don't know that PPHM could sell the tech to BP at discount rates to avoid death. PPHM licensed the tech from other entities. The other entities would just offer it to BP, happens all the time.
HCV/HIV coinfect. I never said it wasn't fruitful effort, you did. I think it's the company's last "hail Mary" as far as HCV is concerned.
Maybe BP wasn't impressed
If BP was impressed, we'd be reading a PR about a merger, cash tender. Look at the PPS. See folks can claim the "management is holding out scenario" all day long. The facts are GBM is not a big money maker, HCV for SOC patients is a bust ala VRTX, and hundreds of biotechs are trying to make cancer SOC better.... where is the impressive data? There are no billions to be made for a GBM indication, nor HCV when the candidate is not even continuing enrollment in HCV SOC trials.
PPHM keeps chugging along with drug candidates, a group of scientists working the petri dishes, animalia, etc., Bavi is the third mab, no one appears to be jumping up and down!
Hence, the dilution.
katie...
Is Letvin monkey trial complete?
Did SK mention anything on the last CC about this trial? Anything? Did he say the word "Letvin"?
katie...
The posts on the PPHM threads are most amusing.
Keep it up boys.
Did anyone find out what happened to the multiple HCV cohorts which were projected to commence in the last two years? Did management ever admit Bavi could not compete with other investigational SOC candidates, therefore, they are advancing it into the coinfection study?
What's happening with the AC Phase I trial, the one that's been enrolling for two years now, still enrolling 28 patients? Did management give any indication in the last CC?
Dilution always means BP wasn't impressed with data presented thus far.
katie....
Parion Sciences and Gilead Sciences Sign Agreement to Advance Drug Candidates for Pulmonary Disease
GILD goes fishing in RTP again, Parion only has ten employees, nice deal for such a small company, double-digit royalties, and the compound is still in pre-clinical stage.
Wednesday August 15, 4:15 pm ET
Companies Will Initially Focus Research Efforts in Cystic Fibrosis
DURHAM, N.C. & FOSTER CITY, Calif.--(BUSINESS WIRE)--Parion Sciences, Inc. and Gilead Sciences, Inc. (Nasdaq:GILD - News) today announced that they have entered into an exclusive licensing and co-development agreement focused on P-680, an epithelial sodium channel (ENaC) inhibitor discovered by Parion, a privately-held, development-stage pharmaceutical company dedicated to treating serious diseases resulting from the failure of the body's mucosal defenses. The agreement grants Gilead worldwide commercialization rights to P-680 for the treatment of pulmonary diseases, including cystic fibrosis (CF), chronic obstructive pulmonary disease (COPD) and non-CF bronchiectasis. In addition, the companies will collaborate on a research program to identify other promising ENaC blocker-based drug candidates utilizing Parion's proprietary ENaC-based chemistry platform.
According to the terms of the agreement, Gilead will provide an upfront payment of $5 million for the license and make an additional $5 million investment in Parion. In addition, under the license, Gilead will supply research funding and may make payments upon achievements of certain milestones resulting in a potential deal value of approximately $146 million. Parion will perform the IND-enabling studies for P-680 and will transition development responsibilities to Gilead during the Phase I clinical trial period. Parion will also be eligible to receive up to double-digit royalties based on potential future product sales.
ENaC inhibitors are unique therapeutic agents that stimulate and maintain hydration on the body's mucosal surfaces, including those on the lung, mouth, nose, eye and gastrointestinal tract. Restoring the hydration of mucosal airway surfaces addresses the fundamental problem that produces infections in both acquired and genetic forms of chronic lung disease, including COPD and CF.
"This agreement validates the importance of ENaC inhibitors in the treatment of diseases involving defects in the innate defenses of the body's mucosal surfaces," said Paul Boucher, Director of Operations of Parion. "This partnership enables us to accelerate our development of P-680 and broaden our research programs. We are pleased to have the support of a company with an outstanding track record in the field of infectious diseases and pulmonary medicine."
"Gilead is committed to building a pipeline of novel respiratory therapeutics to advance the care of patients suffering from life-threatening diseases, and this partnership complements our program for development of aztreonam lysine for inhalation for treatment of CF-related lung infections," said A. Bruce Montgomery, MD, Senior Vice President, Head of Respiratory Therapeutics, Gilead Sciences. "We will work closely with Parion to complete preclinical development of P-680 in the hopes of advancing it into clinical studies."
About Parion Sciences
Based in Durham, NC, Parion Sciences is a privately-held, development-stage pharmaceutical company that is leveraging its proprietary small molecule chemistry and epithelial biology expertise to discover and develop an innovative pipeline of therapies for diseases resulting from the failure of the body's mucosal defenses, including chronic obstructive pulmonary disorder (COPD), cystic fibrosis, bronchiectasis, Sjogren's Syndrome and dry eye. Parion's lead product candidate, P-552, is currently in a Phase II clinical trial for the treatment of cystic fibrosis and Sjogren's syndrome. Parion was founded based on technology from University of North Carolina, Chapel Hill (UNC-CH) and has received grant funding from the National Institutes of Health (NIH) and the Cystic Fibrosis Foundation Therapeutics, Inc.
For more information about Parion, please visit www.parion.com.
For more information about the Cystic Fibrosis Foundation, please visit www.cff.org.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia. Visit Gilead on the World Wide Web at www.gilead.com.
OT: Xzoneclone.
I 'know' you will conquer.
Titanium is the best, your spirit is superior.
Selfish is not the game in this company.
The drugs do not entice BP. Period.
Hence the latest dilution. It's that simple.
katie....take care
Clevudine-LFMAU appears there is are high expectations for Clevudine
Years ago this drug was licensed from Bukwang to another company GILD eventually bought. The CEO of that company known as VIRS, thought Clevudine would be a breakthrough for treating HBV, it was licensed based on woodchuck models. When GILD bought the company, the rights/licensure of Clevudine was dissolved and returned to Bukwang. Pharmasset then licensed the compound.
what does it face in P3 trials, that it did not face in S. Korea?
Dew stated it's being compared to GILD's Hepsera. GILD returned Clevudine to Bukwang for two reasons. 1). The original stakes i.e. royalty, expenses, deal structure was considered too high at the time the GILD bought the company. 2). GILD had Hepsera on the market, with GSK being the marketeer in Asia.
possible SVR for HBV?
I remember speaking about Clevudine results with two execs from VIRS at a shareholder meeting, they thought the drug was demonstrating compelling efficacy after a small 28 day dose escalation study, without any safety issues.
I'm certainly interested to see the data from the upcoming pivotals. With 63 million on hand, I expect VRUS to raise more capital to launch the studies. One advantage Asia has is more rapid enrollment given patient pool vs. America and Europe, the PR stated Americas so perhaps they will enroll in South America. These pivotals will require many enrollment sites in order to file an NDA by 2009/10.
katie....
a number of biotech hedge funds are being forced to liquidate positions
Which ones?
There could be some funds shorting IDIX, given the recent news regarding their Hep-C program.
Now they want to develop an HIV nuke to compete with Sustiva. Good luck with that! Sustiva has been on the market for years, it's also one third of GILD's Truvada, the three in one pill.
katie...
DNDN...never a dull moment with this company.
But Dendreon's small clinical trial was not designed to measure survival, and the FDA rarely gives its approval under such circumstances
Care to Live is suing the wrong folks IMO. Ding dong.
katie...
IMHO, NVS agreed with this assessment and was more than happy to kill the program
HCV development is fiercely competitive and very costly to conduct large pivotal trials. NVS and the FDA apparently viewed the safety profile was too great to continue development, along with high discontinution rates and not to mention, a waste of money too. Interesting that IDIX stated clinical hold, when it appears NVS decided to halt development based on the FDA's perspective. The PR reads like IDIX is pointing the finger at the FDA as the bad guy!
Since I'm long and underwater, it's time for NVS to make a tender offer! Hope you're right.
katie...
It’s moot now because the FDA itself doesn’t want the program to continue
So, did the FDA place a clinical hold on the program, or did Idenix voluntarily place the program on hold as result of the FDA's perspective.
Would NVS consider marketing the drug in Asia/China/Europe still?
katie...
Dear Obie,
How's that financing at 2.00? I'm looking for that 300% move.
Tell us about the trainwreck!!!!
ROTFLMCAO...
Women do make great investors!
katie...
Panacos Announces Substantial Antiviral Response in Bevirimat 250 mg Cohort, Data Support Further Dose Escalation in Phase 2b Study
Wednesday June 20, 4:02 pm ET
Company to Hold a Conference Call at 5:00 p.m. EDT Today
WATERTOWN, Mass.--(BUSINESS WIRE)--Panacos Pharmaceuticals, Inc. (NASDAQ: PANC - News), a biotechnology company dedicated to developing the next generation of antiviral therapeutic products, today announced preliminary results from the 250 mg cohort of a Phase 2b study of bevirimat (PA-457) in patients failing HIV therapy due to drug resistance. Bevirimat plasma concentrations and antiviral effect were approximately double those seen in the first Phase 2b cohort that had used a suboptimal tablet formulation. No safety or tolerability issues with bevirimat arose in this cohort, consistent with previous clinical experience. The results of the 250 mg cohort support further dose escalation as planned in order to fully explore the dose-response relationship of bevirimat.
Following dosing with 250 mg of bevirimat solution administered on top of patients' failing background regimens, the mean trough plasma concentration of bevirimat at steady state was 38.3 micrograms/ml compared to 19.9 micrograms/ml at steady state in the 400 mg tablet cohort. These plasma concentrations were also higher than the steady state concentration of 33.8 micrograms/ml seen in the top dose of the earlier Phase 2a monotherapy study, and were in line with expectations based on previous clinical studies of the oral solution formulation.
A mean viral load reduction of 0.68 log10 was seen in bevirimat treated patients on day 15, the primary endpoint of the study. This compared to placebo patients who had a mean increase in viral load of 0.18 log10 and to bevirimat patients in the 400 mg tablet cohort, who had a mean reduction in viral load of 0.36 log10. At the 250 mg dose, 71% of patients had a confirmed viral load reduction of at least 0.50 log10 during the course of the study. The antiviral effect in the 250 mg cohort was comparable to the 200 mg cohort in the Phase 2a study at day 11, the primary endpoint of the Phase 2a study. The mean viral load reduction in the 250 mg cohort in the current study of highly treatment-experienced patients was 0.79 log10, compared to 0.90 log10 in the 200 mg cohort in the Phase 2a study of mostly treatment-naive patients.
"We were pleased to have these data supporting bevirimat's efficacy in patients failing therapy due to resistance - the initial target population for our first planned NDA submission," said Alan W. Dunton, M.D., Panacos' Chief Executive Officer. "This confirms our belief that the lower than expected plasma concentrations observed in the earlier 400 mg tablet cohort were caused by the prototype tablet formulation, and not by bevirimat itself. In the 250 mg cohort, we saw potent antiviral activity that was consistent with bevirimat plasma levels, which supports going to higher doses to achieve greater responses. We anticipate completing a 300 mg dose cohort in the third quarter, continuing to escalate towards the peak of the dose-response curve thereafter."
About the Phase 2b Bevirimat Study
The objectives of the Phase 2b study of bevirimat are to examine the antiviral efficacy, pharmacokinetics, and safety of bevirimat in combination with other HIV drugs. The first cohort in this study, which used a tablet dose of 400 mg, was completed in December 2006. The results of this cohort confirmed the antiviral activity of bevirimat shown in previous studies and extended it to HIV patients failing therapy due to antiretroviral resistance. However, the prototype tablet formulation used in that cohort resulted in bevirimat plasma concentrations that were lower than anticipated.
A revised Phase 2b trial design was announced in March 2007. The new design tests the tolerability and efficacy of bevirimat in treatment-experienced patients failing current therapy at increasing doses using the oral liquid formulation which was utilized in the bevirimat Phase 2a trial. Phase 2b dose escalation with the liquid formulation involves 14-day "functional monotherapy," where patients are dosed with either placebo or bevirimat in combination with their failing antiretroviral therapy. This design is similar to the first Phase 2b cohort, except that patients do not continue on to extended dosing, which was a feature of the tablet cohort. The primary endpoints of the trial are safety, pharmacokinetics, and viral load reduction on day 15. Panacos plans to continue escalating the dose in subsequent cohorts by 50 mg per cohort following a review by the Company, FDA, and outside clinical experts of the safety and antiviral response from each preceding cohort, releasing data from each cohort as analysis is completed.