|La Jolla Announces Planned Initiation Of Phase 3 LJPC-501; Pluristem Initiates Phase II Intermittent Claudication Trial|
|By Staff and Wire Reports|
|Tuesday, 08 July 2014 19:35|
La Jolla Pharmaceutical Company (NASDAQ: LJPC), a biotechnology company developing therapeutics targeting significant unmet, life-threatening diseases, today announced that the Company plans to begin a phase 3 registration program for LJPC-501 for the treatment of catecholamine-resistant hypotension (CRH), a new indication. Initiation of this registration program is the result of a recent meeting between the Company and the U.S. Food and Drug Administration at which agreement was reached that blood pressure is an appropriate primary endpoint for approval.
“We are excited to begin a registration program in CRH,” said George F. Tidmarsh, M.D., Ph.D., President and CEO of La Jolla. “There are approximately 75,000-100,000 patients per year who suffer from CRH, and the prognosis is very poor. We are excited to advance LJPC-501 into a registration trial for this significant unmet medical need.”
Hypotension, if uncorrected, is life-threatening and occurs as the result of various underlying conditions such as blood loss due to trauma, septic shock, poor heart function or drug reactions. The first line of treatment is catecholamine infusion. Catecholamines are derived from the amino acid tyrosine and include epinephrine (adrenaline), norepinephrine (noradrenaline), and dopamine, which act as neurotransmitters that increase blood pressure. While largely effective, some patients fail to respond to adequate doses and are defined as catecholamine-resistant. Furthermore, high doses of catecholamines can lead to cardiac and other toxicities, and can contribute to the high rate of mortality in these patients. Therefore, there is a major unmet need for a new pharmacological agent that can restore blood pressure while maintaining catecholamine doses at acceptable levels.
LJPC-501 (angiotensin II) is a peptide agonist of the renin-angiotensin system that acts to stabilize blood pressure. One of the most widely prescribed classes of blood pressure medication, angiotensin converting enzyme inhibitors, inhibits the production of angiotensin II, thereby reducing blood pressure. A randomized, placebo-controlled pilot study of angiotensin II in 20 patients with catecholamine-resistant hypotension was presented at the 34th International Symposium on Intensive Care and Emergency Medicine by Dr. Lakhmir S. Chawla from George Washington University. This study demonstrated that the mean norepinephrine dose for the placebo cohort was 20.1 ± 16.8 μg/minute vs. 7.3 ± 11.9 μg/minute for the angiotensin II cohort (P = 0.022). This was the pre-defined primary endpoint and a surrogate measure of blood pressure effect. Approximately 80% of patients treated with angiotensin II experienced a rise in blood pressure compared to 10-20% with placebo. The most common adverse event was hypertension, which occurred in 20% of patients receiving angiotensin II. Due to the estimated size of the patient population in the United States for this indication, the Company has filed for Orphan Drug status for angiotensin II.
Conference Call and Webcast -- The Company will hold an investor conference call and webcast at 8:00 AM Eastern Time/5:00 AM Pacific Time on Wednesday, July 9, 2014. You can participate on the call by either dialing (877) 359-9508 pin: 71366477 or click here for the webcast.
Pluristem Therapeutics Inc., (NASDAQ:PSTI) a leading developer of placenta-based cell therapies, today announced the initiation of South Korean sites in the Phase II study assessing PLacental eXpanded (PLX) cells in the treatment of intermittent claudication (IC). Patient screening is now underway at three clinical centers, making South Korea the fourth country to participate in this randomized, double-blind, placebo-controlled Phase II trial . The trial has been ongoing at clinical sites in the U.S., Israel and Germany with an enrollment target of 150 patients.
The South Korean part of the study is being conducted by CHA Bio & Diostech (kosdaq:CHA) under an exclusive licensing agreement for the use of PLX cells for peripheral artery disease (PAD) in South Korea. Under the terms of Pluristem's licensing agreement with CHA, if there is regulatory approval for a PLX product in South Korea Pluristem and CHA will establish a joint venture (JV) co-owned by the parties; they will share the revenues and income generated through sales of PLX cell therapies in the South Korean market. It is estimated that one million people in South Korea suffer from PAD and this number is expected to grow.
"We have a very productive partnership with CHA, as evidenced by our joint clinical program. Initiating our first trial in South Korea is a major milestone. We look forward to reporting further progress on our Phase II IC trial in the South Korean market," stated Pluristem CEO Zami Aberman.
In May, Pluristem received clearance from the South Korean Ministry of Food and Drug Safety (MFDS) to use PLX cells in South Korean trials.
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