All posts in Peptide News from Biotech and Pharma

Source: http://globenewswire.com/

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SAN DIEGO--(BUSINESS WIRE)--La Jolla Pharmaceutical Company (Nasdaq: LJPC) (the Company or La Jolla), a leader in the development of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases, today announced that the first patient has been dosed in a Phase 1 clinical trial of LJPC-401, La Jolla’s novel formulation of hepcidin.

The Phase 1 clinical trial is a multicenter, open-label, dose-escalation trial that is evaluating the safety, tolerability and effect on serum iron parameters, and pharmacokinetics of LJPC-401 in patients at risk of iron overload due to conditions such as hereditary hemochromatosis (HH), beta thalassemia and sickle cell disease (SCD). Preliminary results from this clinical trial are anticipated by the end of 2015.

LJPC-401 is La Jolla’s novel formulation of hepcidin, a naturally occurring peptide hormone that is the body’s regulator of iron absorption and distribution. Hepcidin prevents excessive iron accumulation in vital organs, such as the liver and heart, where it can cause significant damage and even result in death. La Jolla is developing LJPC-401 for the potential treatment of iron overload, which occurs as a result of diseases such as HH, beta thalassemia and SCD.

Read more: http://www.businesswire.com/news/home/20151019005433/en/La-Jolla-Pharmaceutical-Company-Doses-Patient-Phase

Source: http://www.cbs19.tv/

San Diego, USA – October 15, 2015 /PressCable/ — Kalos is globally known for their pioneering approach to cancer treatment by developing peptides made primarily in the heart, as a cytostatic therapeutic for treating aggressive cancers by engaging known pathway receptors more efficiently without the side effects associated with chemotherapeutic or small molecule compounds. Therefore the announcement of their lead drug candidate, KTH-222, has been hailed as a breakthrough cancer drug capable of besting current treatments in terms of efficacy and simultaneously avoiding the tremendous cascade of side effects typically associated with chemotherapy.

Lead Drug Candidate 1: KTH-222, Pancreatic Cancer

“Based on extensive work with human cancer cells lines and, more recently, models of human cancer, we have selected KTH-222 for clinical development to treat pancreatic cancer. The data indicates that KTH-222 may be more effective for treating this disease than current therapies while producing fewer adverse side effects” stated CSO Dr. Michael Kozlowski.

Even without optimizing the dose or the dosing regimen, KTH-222 produced a reduction in tumor growth and has now surpassed that of the standard of care, gemcitabine (Gem), which optimally dosed.

Read more: http://www.cbs19.tv/story/30265454/kalos-therapeutics-announces-selection-of-new-lead-drug-candidates

Source: http://globenewswire.com/

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COPENHAGEN, Denmark, Oct. 9, 2015 (GLOBE NEWSWIRE) -- Zealand announces that Boehringer Ingelheim has selected a novel peptide therapeutic to be advanced into preclinical development under one of two ongoing collaboration agreements between the companies. This collaboration, initiated in July 2014, covers a novel therapeutic peptide project from Zealand's preclinical portfolio with the aim of Zealand and Boehringer Ingelheim to join forces in the design and development of novel medicines for improved treatment of patients with cardio-metabolic diseases. The biological target is not being disclosed.

Under the terms of the agreement, the companies have successfully advanced therapeutic peptides stemming from the collaboration towards preclinical development. With the selection of a first preclinical candidate, Boehringer Ingelheim will now be responsible for the conduct and funding of the preclinical and potentially clinical development as well as commercialization. The event has triggered a milestone payment from Boehringer Ingelheim to Zealand.

Source: http://www.prweb.com/

Irvine, CA (PRWEB)October 06, 2015: Bioniz, a biopharmaceutical company leading the discovery and development of first-in-class multiple-cytokine inhibitory therapeutics to address immunoinflammatory diseases and cancer immune-therapy, announced today its first two scientific publications in the prestigious peer-reviewed journals JBC and PNAS.

“These publications validate how Bioniz’s novel technology effectively selects and targets biologically redundant cytokines, an unprecedented functionality, which we believe will lead to the creation of a new and major class of drugs that comprehensively address the multiple drivers characteristic of immune system diseases,” said Nazli Azimi, CEO of Bioniz and co-inventor of the technology. “The issue of cytokine redundancy has been an obstacle to the development of effective anti-cytokine therapies. The current therapeutic approaches have been limited either to single monoclonal antibody (MAB) therapies against individual cytokines or to the use of JAK inhibitors that too broadly and non-exclusively block the downstream signaling components that follow cytokine activation. Humira, the monoclonal antibody set to eclipse Lipitor as the largest drug of all time, exemplifies the vast market potential of cytokine modulation. Even though Humira targets only one cytokine and is not highly specific to many of the disease states that have adopted it, it has still shown tremendous success for patients and created incredible market value. We hope to contribute such value many fold.”

Read more: http://www.prweb.com/releases/2015/09/prweb12984464.htm

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CAMBRIDGE, Mass., Oct. 6, 2015 /PRNewswire/ -- Tarix Orphan LLC, a privately held biopharmaceutical company focused on the treatment of rare neuromuscular disorders and connective tissue diseases, today announced that the U.S. Food and Drug Administration has granted Fast Track Designation to TXA127 (angiotensin 1-7) to reduce skeletal muscle damage and fibrosis and thereby improve muscle strength in Duchenne Muscular Dystrophy (DMD) patients. Tarix Orphan has received notice that clinical testing under the company's Investigational New Drug (IND) application for TXA127 may proceed, and the company expects to initiate a multi-site Phase 2 safety and efficacy study in patients with DMD in early 2016 at both U.S. and European trial sites. Tarix has previously received Orphan Drug Status for TXA127 in the DMD indication in both the United States and Europe.

"Studies with TXA127 have shown significant development potential in preclinical models of Duchenne Muscular Dystrophy, Limb Girdle Muscular Dystrophy, and congenital muscular dystrophy, MDC1A and other conditions associated with the TGF-beta pathway. This peptide has several biological actions and has shown positive effects in animals including reductions in muscle fibrosis, increases in muscle strength and ambulation in affected animals, as well as normalization of cardiac dysfunction," said Rick Franklin, Tarix Orphan Chief Executive Officer. "We look forward to beginning our multi-site international Phase 2 study in DMD patients in early 2016. We are additionally preparing a clinical protocol for a study of TXA127 in children with congenital muscular dystrophy (MDC1A), and hope to initiate studies in 2016 in that indication, for which there are no current treatments."

Read more: http://www.prnewswire.com/news-releases/tarix-orphan-receives-fda-fast-track-designation-for-txa127-as-potential-treatment-for-duchenne-muscular-dystrophy-300154790.html

Source: http://www.prnewswire.com/

NEW YORK, Oct. 1, 2015 /PRNewswire/ -- Dipexium Pharmaceuticals, Inc. (NASDAQ: DPRX), a late-stage pharmaceutical company focused on the development and commercialization of Locilex® (pexiganan cream 0.8%), a novel, broad-spectrum, topical antibiotic peptide, today announced that its OneStep-2 pivotal Phase 3 clinical trial has reached the 50% enrollment milestone.  OneStep-1 and OneStep-2 are identical, pivotal Phase 3 clinical trials (180 patients per clinical trial) being conducted under a Special Protocol Assessment (SPA) agreement between the U.S. Food and Drug Administration and Dipexium for evaluation of Locilex® for the treatment of patients with mild infections of diabetic foot ulcers.

As of today, OneStep-1 and OneStep-2 are approximately 56% and 50% enrolled, respectively. In addition, in the aggregate, 62 clinical trial centers are open for enrollment across both pivotal Phase 3 clinical studies. The Company is targeting a New Drug Application (NDA) submission in the second half of 2016. More information about the OneStep-1 and OneStep-2 pivotal Phase 3 clinical trials is available at www.clinicaltrials.gov.

Read more: http://www.prnewswire.com/news-releases/dipexium-pharmaceuticals-reaches-50-enrollment-in-second-pivotal-phase-3-clinical-trial-300152550.html