La Jolla Pharmaceutical Company Submits IND for LJPC-501
Jun 4, 2013 08:02:20 (ET)
SAN DIEGO, CA, Jun 04, 2013 (Marketwired via COMTEX) -- La Jolla Pharmaceutical Company (otcqb:LJPC) ("La Jolla" and "Company") announced today that is has submitted its investigational new drug ("IND") application to the FDA Division of Cardiovascular and Renal Products for LJPC-501. This IND is for the treatment of patients with Type 1 and Type 2 hepatorenal syndrome ("HRS"). HRS is a life-threatening form of progressive renal failure in patients with liver cirrhosis or fulminant liver failure.
HRS is categorized into two types based on the rapidity of the progression of renal failure as measured by serum creatinine. Type 1 HRS is the more rapidly progressing type and is characterized by a 100% increase in serum creatinine to >2.5 mg/dL within two weeks. Less than 10% survive hospitalization, and the median survival is only a few weeks. Type 2 HRS is slower progressing, with serum creatinine rising gradually; however, these patients can develop sudden renal failure and become diagnosed with Type 1 HRS. Type 2 HRS patients survive four to six months on average.
"Submission of the IND for LJPC-501 demonstrates our commitment to developing a strong pipeline for the future of La Jolla," said George Tidmarsh, M.D., Ph.D., President and Chief Executive Officer of La Jolla. "We hope LJPC-501 will benefit patients with HRS, especially given that there are no approved therapies for this fatal disease."
Initiation of a Phase 1 trial is expected later this year. The clinical study cannot begin before the IND is accepted by FDA.
About Hepatorenal Syndrome
HRS is a life-threatening form of progressive renal failure in patients with liver cirrhosis. In these patients, the diseased liver secretes vasodilator substances (e.g., nitric oxide and prostaglandins) into the bloodstream that cause under-filling of blood vessels. This low blood pressure state causes a reduction in blood flow to the kidneys. As a means to restore systemic blood pressure, the kidneys induce both sodium and water retention, which contribute to ascites, a major complication associated with HRS.
About LJPC-501
LJPC-501 is a peptide agonist of the renin-angiotensin system that acts to help the kidneys balance body fluids and electrolytes. Studies suggest that LJPC-501 may improve renal function in patients with HRS.
About La Jolla Pharmaceutical Company
La Jolla Pharmaceutical Company is a biopharmaceutical company dedicated to the development of medical treatments that significantly improve outcomes in patients with life-threatening diseases. GCS-100, the Company's lead product candidate, is a first-in-class inhibitor of galectin-3, a novel molecular target implicated in chronic organ failure and cancer. LJPC-501 is a product candidate for the treatment of hepatorenal syndrome. For more information on the Company, please visit http://www.ljpc.com .
Forward-Looking Statement Safe Harbor
This document contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements relate to future events or our future results of operations. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, which may cause actual results to be materially different from these forward-looking statements. The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date they were made. Certain of these risks, uncertainties, and other factors are described in greater detail in the Company's filings from time to time with the U.S. Securities and Exchange Commission ("SEC"), all of which are available free of charge on the SEC's web site http://www.sec.gov . These risks include, but are not limited to, risks relating to the development of GCS-100 and LJPC-501, the success and timing of future preclinical and clinical studies of this compound, and potential indications for which GCS-100 and LJPC-501 may be developed. Subsequent written and oral forward-looking statements attributable to the Company or to persons acting on its behalf are expressly qualified in their entirety by the cautionary statements set forth in the Company's reports filed with the SEC. The Company expressly disclaims any intent to update any forward-looking statements.
Company Contact
George F. Tidmarsh, M.D., Ph.D. President & Chief Executive Officer La Jolla Pharmaceutical Company Phone: (858) 207-4264 Email: GTidmarsh@ljpc.com
And
Chester S. Zygmont, III Director of Finance La Jolla Pharmaceutical Company Phone: (858) 207-4262 Email: czygmont@ljpc.com
Echo Therapeutics Initiates CE Mark Clinical Trial of its Symphony CGM System
Jun 5, 2013 07:50:00 (ET)
PHILADELPHIA, June 5, 2013 /PRNewswire via COMTEX/ -- Echo Therapeutics, Inc. , a company developing its needle-free Symphony CGM System as a non-invasive, wireless continuous glucose monitoring system, today announced that it is initiating a multi-center clinical trial of its Symphony CGM System to support a CE Mark Technical File for marketing approval in Europe. The Company expects to enroll patients over the coming weeks and announce the results of the study in the third quarter of 2013.
"This clinical study is a milestone event for Echo Therapeutics and we are extremely excited to begin recruitment of patients for enrollment in the trial. It is the final step before the submission of the CE Mark Technical File for potential market clearance and ensuing European commercial launch of Symphony," commented Patrick T. Mooney, M.D., Chairman and CEO of Echo Therapeutics. "We look forward to providing updates in the near-term as we move toward our goal of making Symphony available to patients."
The clinical study is designed to evaluate the safety and efficacy of the Symphony CGM System in a hospital setting. Glucose data will be collected from thirty-two (32) critically ill patients at four U.S. medical institutions. The Symphony CGM System glucose readings will be paired with reference blood glucose measurements taken from a YSI 2300 STAT Plus Glucose Analyzer.
About Echo Therapeutics
Echo Therapeutics is developing the Symphony CGM System as a non-invasive, wireless continuous glucose monitoring system. Our target is patients who could benefit from glucose monitoring in the hospital setting, including critical care. Significant opportunity also exists for patients with diabetes to use Symphony in the outpatient setting. Echo is also developing its needle-free skin preparation component of Symphony, the Prelude Skin Prep System, as a platform technology to enhance drug delivery of topical pharmaceuticals.
The statements in this press release that are not historical facts, including statements regarding the timing of patient enrollment and the announcement of study results, may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to the timing of patient enrollment, regulatory approvals and the success of Echo's ongoing studies, including the safety and efficacy of Echo's Symphony CGM System, the failure of future development and preliminary marketing efforts related to Echo's Symphony CGM System, Echo's ability to secure additional commercial partnering arrangements, risks and uncertainties relating to Echo's and its partners' ability to develop, market and sell the Symphony CGM System, the availability of substantial additional equity or debt capital to support its research, development and product commercialization activities, and the success of its research, development, regulatory approval, marketing and distribution plans and strategies, including those plans and strategies related to its Symphony CGM System. These and other risks and uncertainties are identified and described in more detail in Echo's filings with the Securities and Exchange Commission, including, without limitation, its Annual Report on Form 10-K for the year ended December 31, 2012, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. Echo undertakes no obligation to publicly update or revise any forward-looking statements.
For More Information: Christine H. Olimpio Director, Investor Relations and Corporate Communications (215) 717-4104
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