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La Jolla Pharmaceutical Provides Update On Phase 3 International Riquent(R) Study
La Jolla Pharmaceutical Company (Nasdaq: LJPC) announced today considerable progress on its Phase 3 trial of Riquent(R) (abetimus sodium) for the treatment of lupus renal
disease. Since the August 9, 2006 announcement that the study had been
reactivated, the Company has added another 27 clinical trial sites able to
screen and enroll patients, for a total of 58 sites, 22 in the United
States and 36 in Asia.
Ninety-nine patients are currently being screened for potential
enrollment in the study. We estimate that 30% to 50% of the patients in
screening should be eligible for study enrollment.
In addition to sites in Asia and the U.S., sites are being added in
Europe, Mexico and possibly South America, to bring the total number of
sites to approximately 100. These sites are targeted to enroll patients
before the end of 2006.
"We are aggressively moving forward to open new sites and enroll
patients, and I am pleased that in only six weeks, we already have 99
patients in screening," said Deirdre Y. Gillespie, M.D., President and CEO
of La Jolla Pharmaceutical Company. "We now plan to add at least 20
additional sites beyond the initial 100 to further accelerate and
strengthen enrollment in the trial. We expect to begin activating these
additional sites before the end of the year. Our target for completing
patient recruitment is the second half of 2007."
This Phase 3 study is planned to enroll approximately 600 patients, and
most of these patients will be treated with higher doses than in previous
studies. This trial will assess a 300 mg per week and a 900 mg per week
dose, as well as the 100 mg per week dose used in the prior Phase 3 trial.
Of the 600 patients, two-thirds will be treated with Riquent, and the
majority of the Riquent-treated patients will receive one of the two higher
doses.
About Riquent
Riquent is the first drug candidate specifically developed for the
treatment of lupus renal disease, a leading cause of sickness and death in
lupus patients. The drug candidate has already been evaluated in 13
clinical trials over a 10-year time span that evaluated more than 800
patients and subjects. Riquent has been well tolerated in all of these
studies, with no serious side effects identified to date. Riquent's only
known biological activity is the reduction of antibodies to double-stranded
DNA (dsDNA) that are associated with the progression of lupus renal disease
and renal flares. In all clinical trials where antibodies to dsDNA were
measured, Riquent treatment has significantly reduced these antibody
levels. Data generated from the Company's previous Phase 2/3 and Phase 3
trials indicated that patients with lower antibody levels experienced
significantly fewer renal flares and improved health-related quality of
life.
About Lupus
Lupus (systemic lupus erythematosus) is a chronic, potentially
life-threatening autoimmune disease. About 90% of lupus patients are
female, and many develop 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.
La Jolla Pharmaceutical Company is a biotechnology company developing
therapeutics for antibody-mediated autoimmune diseases and inflammation
afflicting several million people around the world. The Company's leading
product in development is Riquent(R), which is designed to treat lupus
renal disease, a leading cause of sickness and death in patients with
lupus. The Company is also developing small molecules 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/.
The forward-looking statements in this press release involve
significant risks and uncertainties, and a number of factors, both foreseen
and unforeseen, that could cause actual results to differ materially from
our current expectations. Forward-looking statements include those that
express a plan, belief, expectation, estimation, anticipation, intent,
contingency, future development or similar expression. The analyses of
clinical results of Riquent, previously known as LJP 394, our drug
candidate for the treatment of systemic lupus erythematosus ("lupus"), and
any other drug candidate that we may develop, including the results of any
trials or models that are ongoing or that we may initiate in the future,
could result in a finding that these drug candidates are not effective in
large patient populations, do not provide a meaningful clinical benefit, or
may reveal a potential safety issue requiring us to develop new candidates.
The analysis of the data from our previous Phase 3 trial of Riquent showed
that the trial did not reach statistical significance with respect to its
primary endpoint, time to renal flare, or with respect to its secondary
endpoint, time to treatment with high-dose corticosteroids or
cyclophosphamide. The results from our clinical trials of Riquent,
including the results of any trials that are ongoing or that we may
initiate in the future, may not ultimately be sufficient to obtain
regulatory clearance to market Riquent either in the United States or
Europe, and we may be required to conduct additional clinical studies to
demonstrate the safety and efficacy of Riquent in order to obtain marketing
approval. There can be no assurance, however, that we will have the
necessary resources to complete any current or future trials or that any
such trials will sufficiently demonstrate the safety and efficacy of
Riquent. Our blood test to measure the binding affinity for Riquent is
experimental, has not been validated by independent laboratories and will
likely be reviewed as part of the Riquent approval process. Our SSAO
inhibitor program is at a very early stage of development and involves
comparable risks. Analysis of our clinical trials could have negative or
inconclusive results. Any positive results observed to date in our clinical
trials or animal models may not be indicative of future results. In any
event, regulatory authorities may require clinical trials in addition to
our current clinical trial, or may not approve our drugs. Our ability to
develop and sell our products in the future may be adversely affected by
the intellectual property rights of third parties. Additional risk factors
include the uncertainty and timing of: obtaining required regulatory
approvals, including delays associated with any approvals that we may
obtain; our ability to pass all necessary regulatory inspections; the
availability of sufficient financial resources; the increase in capacity of
our manufacturing capabilities for possible commercialization; successfully
marketing and selling our products; our lack of manufacturing, marketing
and sales experience; our ability to make use of the orphan drug
designation for Riquent; generating future revenue from product sales or
other sources such as collaborative relationships; future profitability;
and our dependence on patents and other proprietary rights. Readers are
cautioned to not place undue reliance upon forward-looking statements,
which speak only as of the date hereof, and we undertake no obligation to
update forward-looking statements to reflect events or circumstances
occurring after the date hereof. Interested parties are urged to review the
risks described in our Annual Report on Form 10-K for the year ended
December 31, 2005, and in other reports and registration statements that we
file with the Securities and Exchange Commission from time to time.
La Jolla Pharmaceutical Company
http://www.ljpc.com/
La Jolla farmaceutice Oferã Update Pe Faza 3 International Riquent (R) de studiu - La Jolla Pharmaceutical Provides Update On Phase 3 International Riquent(R) Study - articole medicale engleza - startsanatate