Jiesen tries to take over the world

[IIC]

Yes, Doug, companies waste money all the time, and at the end of it LJPC may very well have nothing to show for all the money spent. But the work they are doing is anything but a waste.

I realize that research ends in a lot of dead ends...If no one was willing to take the risk...Nothing effective would ever come to light...I was just commenting on Ernie's statement....Maybe something is brewing...Maybe it's not...I have no idea

[Websman]

Time for the big news on LJPC yet???

[jiesen]

Ljpc

Yep, more like past time... there should have been some sort of partnership announced by now, which would be very big indeed, or an interim update on the data. Both are likely imminent. Also, patient enrollment is targeted for completion this quarter. Any one of these announcements should give the stock a boost. I'm encouraged that hiring seems to be picking up, since the latest filing with the proxy statement shows that 95 people are on the payroll now. This means the data should be out, and trial completed sooner.

By my calculation, the first peek at the data (after 43 renal flares) should be available by now, and it may just be a matter of reviewing the data prior to release- or finalizing a finance deal before analyzing the results. At any rate, you're right, now is the time for big news.

[Websman]

We're going to be rich...I can feel it.

[IIC]

Yep, more like past time... there should have been some sort of partnership announced by now, which would be very big indeed, or an interim update on the data. Both are likely imminent. Also, patient enrollment is targeted for completion this quarter. Any one of these announcements should give the stock a boost. I'm encouraged that hiring seems to be picking up, since the latest filing with the proxy statement shows that 95 people are on the payroll now. This means the data should be out, and trial completed sooner.

By my calculation, the first peek at the data (after 43 renal flares) should be available by now, and it may just be a matter of reviewing the data prior to release- or finalizing a finance deal before analyzing the results. At any rate, you're right, now is the time for big news.

Can't remember...Don't you work there?

[jiesen]

Can't remember...Don't you work there?

Nope, I left LJP in 2006. I still hold a significant chunk of stock, but it has shrunk quite a bit since I left. I do expect the trial to succeed, but it's taking a while longer than I thought it would, and I'm feeling better about my decision to leave the longer this goes on. It's getting down to the wire now, though, and we shouldn't have to wait much longer before the stock hits either 0.20 or $20 (probably 1 year at the latest).

I really only started posting anything about this company after I left, since doing so beforehand would have likely gotten me in trouble.

[IIC]

I really only started posting anything about this company after I left, since doing so beforehand would have likely gotten me in trouble.

Guess I missed that post...But that is why I asked...I didn't want you to get in any trouble...I know for a fact that some companies monitor what their employees say on the Net

[jiesen]

good news for LJPC (and me)

from:
http://biz.yahoo.com/bw/080423/20080423005376.html?.v=1

La Jolla Pharmaceutical Announces Positive 12-Month Interim Antibody Data and Provides Update for Ongoing Riquent(R) Phase 3 'ASPEN' Lupus Trial

Wednesday April 23, 7:30 am ET
Significant Reduction in Antibodies Demonstrated
SAN DIEGO--(BUSINESS WIRE)--La Jolla Pharmaceutical Company (NASDAQ:LJPC - News) today announced positive 12-month interim antibody data from its ongoing double-blind, placebo-controlled, randomized Phase 3 study of Riquent® (abetimus sodium), its drug candidate for systemic lupus erythematosus (“SLE” or “lupus”). Analyses of 12-month interim antibody data in the first 125 patients randomized in the study indicate that for all patients treated with 900 mg, 300 mg, or 100 mg of Riquent per week compared with placebo, there were significantly greater reductions in antibodies to double-stranded DNA (dsDNA, p < 0.0001).

Summary of Antibody Data

The data show a dose-response curve for antibody reduction and also show that the 300 mg and 900 mg doses appear to be near the top of the antibody-related dose-response curve, thus supporting the choice of doses for this study. Antibody levels in the placebo-treated group remained around baseline levels throughout the 12 months. The rate at which antibody levels were maximally reduced appeared to be more rapid in the 900 mg dose group than in the 300 mg or the 100 mg dose groups.
“Treatment with all doses of Riquent resulted in significant and sustained reductions in antibodies to dsDNA during the entire one-year treatment period,” said Michael Tansey, M.D., Executive Vice President and Chief Medical Officer of La Jolla Pharmaceutical Company. “Equally important, antibody levels observed in the placebo-treated patients remained around or above baseline and did not drift lower over time as occurred in the previous Phase 3 study. These data, which were generated in patients already receiving background immunosuppressive therapy, suggest that the appropriate doses were chosen for the current study and that overall, the 300 mg and 900 mg doses appear to be more effective than the 100 mg dose in the sustained reduction of antibodies to dsDNA.”
“The 12-month interim antibody data confirm that over the dose range being studied, treatment with Riquent resulted in significant reductions in antibodies to dsDNA,” said Richard Furie, M.D., Chief of Rheumatology, North Shore-Long Island Jewish Health System, and an investigator in the study. “These antibodies are strongly implicated as a primary cause of lupus renal disease, and prior studies have demonstrated that reductions in these antibodies strongly correlate with a reduction in the risk of renal flare.”
Each individual dose group was significantly different from placebo (p < 0.0001). An area under the curve (AUC) analysis, which reflects the effect of the drug on antibody levels over time, showed significantly greater antibody-lowering effects for the 300 mg and 900 mg dose groups compared with the placebo group (decreases of 26.9% for 100 mg, 35.5% for 300 mg, and 37.7% for 900 mg, compared with an increase of 7.5% for placebo).
The AUC analysis provides additional evidence that the higher doses of Riquent suppressed antibodies further than the 100 mg dose group. The proportion of patients achieving a 50% or greater AUC reduction was 0.0% in the placebo and 100 mg groups, 23% in the 300 mg group, and 30% in the 900 mg group.
The 12-month antibody analysis assessed the impact of treatment with Riquent or placebo on antibodies to dsDNA. Antibody levels were measured every two weeks for the first 16 weeks of the study and then monthly for the remaining 36 weeks. All demographics and baseline characteristics were comparable across dosing groups.
Phase 3 Trial Update
The Phase 3 ASPEN trial (“Abetimus Sodium in Patients with a History of Lupus Nephritis”) appears to be progressing well; more than 140 sites are active and more than 670 patients have been enrolled. Compliance with weekly visits has been high and the drop-out rate remains low. The Independent Data Monitoring Board (DMB) has completed three reviews of the safety data and has not indicated any safety issues.
The study is an event-driven trial designed to be completed when 128 renal flares have occurred. The current overall renal flare rate is lower than the original trial assumption. As a result, in an effort to shorten the time to achieve the required number of renal flares, the Company will continue enrollment beyond the initially targeted 740 patients and extend the treatment period beyond 12 months until the required number of renal flares is achieved. The Company now estimates that at least 800 patients will be enrolled in the study. Based on these changes, the Company expects the trial to complete in the second half of 2009.
The Phase 3 trial includes two interim efficacy analyses, each with target p values of p < 0.001 and a final p value of p < 0.05. The Company has added a futility analysis to each interim efficacy analysis. The interim efficacy analyses have been moved to occur later in the study when a greater number of renal flares will have been observed. As a result, the first interim efficacy analysis is expected to occur around the fourth quarter of 2008, and the second interim efficacy analysis is expected to occur about midway between the first analysis and the expected end of the study.
These modifications to the trial have been discussed with the FDA, and the trial continues to be conducted under the FDA’s Special Protocol Assessment.
“The interim results from the ASPEN trial are very encouraging,” said Deirdre Gillespie M.D., President and CEO of La Jolla Pharmaceutical Company. “At this point in the trial enrollment remains strong, the overall renal flare rate is lower than the original trial assumption, and the safety data appear to be consistent with data from our previous trials. These new data appear to show that the 300 mg and 900 mg doses of Riquent reduce antibodies to dsDNA more than the previously studied 100 mg dose.”
Dr. Gillespie added, “We continue to make great progress and believe that the additional refinements to the study will hasten its completion and possibly enable us to observe a definitive outcome earlier.”
Conference Call
The Company will host a conference call on April 23, 2008, at 1:30 pm Pacific Time/4:30 pm Eastern Time. If you would like to listen to the conference call, please access the link on La Jolla Pharmaceutical Company’s Web site at www.ljpc.com.
A replay of the conference call will be available the day of the call on the Company’s Web site www.ljpc.com and will be archived for several weeks. In addition, a replay of the conference call can be accessed by dialing 888-286-8010 (US) or 617-801-6888 (international). The passcode for the replay is 78768082.
Phase 3 Study Design
The Phase 3 study is designed to assess the ability of Riquent treatment to prevent or delay the time to renal flare in lupus patients with a history of renal disease and with antibodies to dsDNA. Equal numbers of patients are being treated with 300 mg per week, 900 mg per week, or placebo. A small number of patients are receiving 100 mg per week. All patients continue to receive standard of care which can include background immunosuppressive therapies.
A lupus renal flare is a potentially life-threatening increase in inflammation of the kidney due to lupus. A renal flare often requires treatment with immunosuppressive agents which can have severe side effects. Riquent is also being studied to assess whether drug treatment decreases proteinuria, as was observed in previous clinical trials. Proteinuria, or protein in the urine, is a common problem for patients with renal disease and is an indicator of renal damage.
Riquent has received an Approvable Letter and Fast Track status from the Food and Drug Administration, and has Orphan Drug designation in the United States and Europe.
About Riquent
Riquent is being developed to specifically treat lupus renal disease by preventing or delaying renal flares, a leading cause of sickness and death in lupus patients. It is also being studied to assess whether Riquent treatment improves proteinuria, as was observed in previous clinical trials. Proteinuria is an indicator of abnormal renal function. Riquent has been well tolerated in all 14 clinical trials, with no overall difference in the adverse event profiles for Riquent-treated patients compared with placebo-treated patients. Riquent specifically reduces circulating levels of anti-dsDNA antibodies and is also designed to specifically suppress the B cells that make these antibodies. Decreases in these antibodies are believed to be associated with a decreased risk of renal flare. Although clinical benefit has not yet been proven, Riquent treatment has significantly reduced these antibody levels in all clinical trials in which they were measured.
About Lupus
Lupus (systemic lupus erythematosus) is a chronic, potentially life-threatening autoimmune disease. About 90% of lupus patients are female, and many are diagnosed with the disease during their childbearing years. Approximately 50% of lupus patients have renal disease which can lead to irreversible renal damage, renal failure and the need for dialysis, and is a leading cause of death in lupus patients. Latinos, African Americans, and Asians face an increased risk of serious renal disease associated with lupus. The current standard of care for lupus renal disease often involves treatment with high doses of corticosteroids and immunosuppressive drugs that can cause severe side effects including diabetes, hypertension, and sterility and may leave patients vulnerable to opportunistic infections. To date, no lupus-specific drug has been approved in the U.S.
About La Jolla Pharmaceutical Company
La Jolla Pharmaceutical Company is dedicated to improving and preserving human life by developing innovative pharmaceutical products. The Company’s leading product in development is Riquent®, which is designed to treat lupus renal disease by preventing or delaying renal flares. Lupus renal disease is a leading cause of sickness and death in patients with lupus. The Company has also developed potential small molecule drug candidates to treat various other autoimmune and inflammatory conditions. The Company's common stock is traded on The NASDAQ Global Market under the symbol LJPC. More information about the Company is available on its Web site: http://www.ljpc.com.

[riverbabe]

Guess I missed that post...But that is why I asked...I didn't want you to get in any trouble...I know for a fact that some companies monitor what their employees say on the Net

As long as he no longer has access to insider info, he should be free and clear. River

[riverbabe]

On the Wires Today LJPC

La Jolla Pharm: Lazard continues to anticipate results from ongoing Phase III trial of Riquent will fail to meet primary endpoint of time to renal flare (1.81 )

Lazard says this morning LJPC reported additional interim antibody data from its ongoing Phase III trial of Riquent for lupus nephritis. The 12-month interim antibody data from the first 125 patients randomized indicate that Riquent led to dsDNA antibody decreases (measured by AUC) of 26.9% for 100 mg, 35.5% for 300 mg, and 37.7% for 900 mg, versus an increase of 7.5% for the placebo arm. Based on firm's analysis of the literature, there is a lack of clinical data linking reductions in dsDNA antibodies to clinical benefit in lupus nephritis. Thus, firm continues to anticipate that results from the ongoing Phase III trial of Riquent will fail to meet the primary endpoint of time to renal flare, mirroring the results of earlier Phase II/III trials.

From: www.briefing.com

[jiesen]

La Jolla Pharm: Lazard continues to anticipate results from ongoing Phase III trial of Riquent will fail to meet primary endpoint of time to renal flare (1.81 )

Lazard says this morning LJPC reported additional interim antibody data from its ongoing Phase III trial of Riquent for lupus nephritis. The 12-month interim antibody data from the first 125 patients randomized indicate that Riquent led to dsDNA antibody decreases (measured by AUC) of 26.9% for 100 mg, 35.5% for 300 mg, and 37.7% for 900 mg, versus an increase of 7.5% for the placebo arm. Based on firm's analysis of the literature, there is a lack of clinical data linking reductions in dsDNA antibodies to clinical benefit in lupus nephritis. Thus, firm continues to anticipate that results from the ongoing Phase III trial of Riquent will fail to meet the primary endpoint of time to renal flare, mirroring the results of earlier Phase II/III trials.

From: www.briefing.com

There actually is clinical data linking dsDNA antibody levels to rate of renal flare, though. Once this trial is complete, there will also be evidence that removing the antibodies reduces the flare rate. Of course there's a lack of *this* data because this is the first drug in Phase III clinical trials that reduces the dsDNA antibodies.

[riverbabe]

There actually is clinical data linking dsDNA antibody levels to rate of renal flare, though. Once this trial is complete, there will also be evidence that removing the antibodies reduces the flare rate. Of course there's a lack of *this* data because this is the first drug in Phase III clinical trials that reduces the dsDNA antibodies.

Super Jiesen! I wish you all kinds of good luck. Riverbabe

[jiesen]

Thanks, Riverbabe!

[Websman]

I sold my LJPC on Friday for two cents below my buy price. I know it's all for a very good cause, but they're killing the shareholders.

[jiesen]

yep, it's killing me... on the upside, the dilution went mainly (81% or so) to the major owners, one of whom owns about 37% (Essex Woodlands) of the company now. but it's definitely a good thing you avoided the dilution by exiting on Friday. Wish I had been as prescient.