La Jolla Announces Planned Initiation Of Phase 3 LJPC-501; Pluristem Initiates Phase II Intermittent Claudication Trial Print E-mail
By Staff and Wire Reports   
Tuesday, 08 July 2014 19:35
Below is a look at some of the headlines for companies that made news in the healthcare sector on July 8, 2014.
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.



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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.




Also Tuesday:



Akers Biosciences Inc (Nasdaq:AKER)
, a leading designer and manufacturer of rapid diagnostic screening and testing products, will visit the NASDAQ MarketSite in Times Square.

Amedisys, Inc. (Nasdaq:AMED)
, one of America's leading healthcare at home companies, announced today that it has been advised by the staff of the Securities and Exchange Commission ("SEC") that the investigation by the SEC related to the Company's operations and participation in the Medicare program has been completed and that the staff does not intend to recommend any enforcement action by the SEC.

AngioDynamics (Nasdaq:ANGO)
, a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, today announced it will report financial results for its fiscal 2014 fourth quarter and full-year ended May 31, 2014, on Wednesday, July 23, 2014, after the close of the U.S. financial markets.

Cesca Therapeutics Inc. (Nasdaq:KOOL)
, an autologous cell-based regenerative medicine company, announced today that it recently participated in a pre-submission IDE (Investigational Device Exemption) teleconference with the Food and Drug Administration's ("FDA") Center for Biologics Evaluation and Research to discuss the Company's proposed pivotal clinical trial design for the treatment of Critical Limb Ischemia ("CLI") using its CLIRST (Critical Limb Ischemia Rapid Stem cell Therapy) treatment protocol delivered via the Company's proprietary SURGWERKS-CLI kit.

Chimerix, Inc. (Nasdaq:CMRX)
, a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced the presentation of three abstracts on its investigational broad-spectrum antiviral, brincidofovir (BCV, CMX001), at the 2014 World Transplant Congress (WTC) being held July 26-31, 2014 at the Moscone West Convention Center in San Francisco.

FutureWorld (OTCQB: FWDG),
the leading provider of advanced solutions to the Cannabis industry globally, announces today that its subsidiary, HempTech Corp., has signed a teaming agreement with Second Sun Grow™ to facilitate and deliver technology innovations to its customers. HempTech will initially offer SmartNergy™ with Facility and Energy CaNNaLyTiX™ as an Energy Management System (EMS) with predictive building automation solutions that leverage an advanced fault detection and diagnostics engine. 

GlobeImmune, Inc. (Nasdaq:GBIM)
, today announced the closing of its previously announced initial public offering of 1,725,000 shares of its common stock at a price to the public of $10.00 per share, which includes 225,000 shares of common stock sold pursuant to the full exercise of the underwriter's overallotment option.

Healthcare Services Group, Inc. (Nasdaq:HCSG)
reported that revenues for the three months ended June 30, 2014 increased approximately 17% to $319,295,000 compared to $273,604,000 for the same 2013 period.

Hemispherx Biopharma, Inc. (NYSE MKT:HEB)
, announced execution of an agreement to seek South African government approval to initiate a study of Alferon® N, the only FDA approved natural interferon, in the suppression of HIV Type 1 replication and the reduction/elimination of functional cell-associated HIV DNA integration (latent HIV).

iKang Healthcare Group, Inc. (Nasdaq:KANG)
, the largest provider in China's fast growing private preventive healthcare services market in terms of revenue in 2013, today announced that the Board of Directors of the Company has appointed and designated Ms. Ruby Lu as an independent director of the Company and a member of the audit committee of the Board, effective July 5, 2014.

India Globalization Capital, Inc. (NYSE MKT: IGC)
announced that it has entered into an agreement with TerraSphere Systems and Greenlife Ventures to develop multiple facilities to produce organic leafy green vegetables utilizing TerraSphere's advanced pesticide free organic indoor farming technology. 

Medical Marijuana Inc. (OTC Pink: MJNA)
, a leading cannabis and industrial hemp industry innovator, today announced the release of its quarterly financial and shareholders report (Post 06/30/2014 - OTC Markets).

MedAssets, Inc. (Nasdaq:MDAS)
today announced that it plans to release its financial results for the second quarter and six-month period ended June 30, 2014 after 4:00 p.m. ET on Wednesday, July 30, 2014.

NeoStem, Inc. (Nasdaq:NBS)
, a leader in the emerging cellular therapy industry, announced today the appointment of Steven M. Klosk to its Board of Directors.

RadNet Inc. (Nasdaq:RDNT)
, a national leader in providing high-quality, cost-effective, fixed-site outpatient diagnostic imaging services through a network of 250 owned and/or operated outpatient imaging centers, announced it has joined a research study, the Imaging and Genetic Biomarkers for Alzheimer's Disease (ImaGene) study.

RedChip Companies, Inc., today announced it has issued a research profile on Akers Biosciences Inc. (Nasdaq:AKER), a leading designer and manufacturer of rapid diagnostic screening and testing products.

Supernus Pharmaceuticals, Inc. (Nasdaq:SUPN)
, today announced the execution of a royalty acquisition agreement with HealthCare Royalty Partners.



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