All posts in Peptide News from Biotech and Pharma

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

ZUG, Switzerland and NEW YORK, Jan. 12, 2016 /PRNewswire/ -- SELLAS Life Sciences Group (SELLAS), a development-stage biopharmaceutical company focused on innovative products to treat cancers and central nervous system (CNS) diseases, today reported positive results from the Company's Phase 1/2 clinical study of its WT1 cancer vaccine in patients with multiple myeloma (MM) following autologous stem cell transplantation. Initial results from the study, which commenced in June 2014 and enrolled a total of 15 patients, have demonstrated positive immune response data and safety findings as well as early efficacy data. Three patients with high-risk cytogenetics achieved an immune response against WT1 peptides encoded in the vaccine, and two of these patients continued in remission at the time of last follow-up at one year; the third patient was in remission as of the first, three-month follow-up and will continue to be followed through one year. Additional clinical results will be reported in 2016 in the appropriate peer-reviewed forum once all of the 15 patients have completed the vaccinations and immune responses have been analyzed. Based on these promising data, SELLAS intends to assess the efficacy of the WT1 cancer vaccine in MM in a larger Phase II/III trial including patients with standard risk disease following induction chemotherapy in 2016.

Guenther Koehne, M.D., Ph.D., Attending Physician, Adult Bone Marrow Transplantation Service, at Memorial Sloan Kettering Cancer Center (MSKCC), Associate Professor of Medicine, Weill Cornell Medical College and Principal Investigator of the Phase I/II trial, commented, "I am excited by the prospect of this WT1 cancer vaccine in treating multiple myeloma, as it has demonstrated strong safety findings and impressive immune response data. While these results are preliminary, it appears patients with high-risk cytogenetics may experience a benefit of progression-free survival with the WT1 vaccine, and we will continue to track closely each patient's progress as we complete the follow-up."

Read more: http://www.prnewswire.com/news-releases/sellas-life-sciences-announces-preliminary-positive-wt1-cancer-vaccine-clinical-results-in-multiple-myeloma-patients-300202643.html

Source:

Protagonist Therapeutics, Inc. and reported by http://www.prnewswire.com/

MILPITAS, Calif., Jan. 8, 2016 /PRNewswire/ -- Protagonist Therapeutics, Inc., a company developing novel, orally-stable peptide therapeutics for gastrointestinal (GI) diseases, today announced that the company has initiated treatment of subjects with its lead drug candidate, PTG-100, in a Phase 1 clinical study. Protagonist is developing PTG-100, an orally-stable alpha-4-beta-7 integrin-specific peptide antagonist, as a potential treatment for patients with inflammatory bowel disease (IBD).

"IBD is a chronic inflammatory disease of the gastro-intestinal tract where there is significant need for improved targeted therapies," said Richard Shames, M.D., Chief Medical Officer at Protagonist. "PTG-100 is the only oral alpha-4-beta-7 specific antagonist currently in development, a target that is clinically validated for IBD by the approval of injectable antibody drugs."

"The initiation of the first human study of PTG-100 is an important milestone for Protagonist, marking our evolution from a research-focused company to one engaged in the clinical development of its own products," said Dinesh Patel, Ph.D., Protagonist President and Chief Executive Officer. "PTG-100 is the first of several orally stable peptides in the Protagonist pipeline. We look forward to applying the lessons we learn from this compound's early development to our other programs."

Read more: http://www.prnewswire.com/news-releases/protagonist-therapeutics-initiates-phase-1-study-with-oral-peptide-ptg-100-300201405.html

Source: http://www.businesswire.com/

ALBUQUERQUE, N.M.--(BUSINESS WIRE)--SolaranRx, a privately held biotechnology company developing a new class of precision medicine for the treatment of metastatic melanoma, today announced that it has entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), part of the National Institutes of Health. SolaranRx and the NCI will work together to advance SolaranRx’s Precision Theranostic Platform™ that employs radiopharmaceutical therapies and companion imaging agents for metastatic melanoma, the most lethal form of skin cancer and highly resistant to current therapies.

Under the CRADA, the two parties will jointly evaluate SRX-1177, SolaranRx’s proprietary lead compound in preclinical mouse models of metastatic melanoma. SolaranRx’s technology precisely targets deadly melanoma tumors with its novel radiolabeled peptide that specifically binds to melanocortin-1 (MC1) receptors over-expressed in about 80 percent of human melanomas.

NCI’s Center for Advanced Preclinical Research (CAPR)’s group will work with SolaranRx to achieve the CRADA goals. SolaranRx CEO Les Stewart will serve as the collaborator principal investigator. CAPR conducts comprehensive preclinical studies to evaluate efficacy of therapeutics and diagnostics for human cancers.

Read more: http://www.businesswire.com/news/home/20160107005910/en/SolaranRx-Signs-Research-Agreement-National-Cancer-Institute

Source: Rhythm and reported by http://www.prnewswire.com/

BOSTON, Jan. 7, 2016 /PRNewswire/ -- Rhythm, a biopharmaceutical company developing peptide therapeutics for rare genetic deficiencies that result in life-threatening metabolic disorders, announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) to setmelanotide, the company's novel melanocortin-4 receptor (MC4R) agonist, for the treatment of pro-opiomelanocortin (POMC) deficiency obesity. Setmelanotide is in Phase 2 clinical trials for the treatment of rare genetic disorders of obesity caused by MC4 pathway deficiencies.

"Patients with POMC deficiency obesity have extreme and unrelenting appetite and obesity because of impaired function in the MC4 pathway," said Keith Gottesdiener, CEO of Rhythm. "We are pleased to receive this breakthrough designation and look forward to working closely with the FDA as we continue to advance the setmelanotide program."

Breakthrough Therapy designation is granted by the FDA to expedite the development and review of therapeutics to treat serious or life-threatening conditions for which preliminary clinical evidence indicates that the therapy may demonstrate substantial improvement on at least one clinically significant endpoint over existing therapies. This designation conveys all FDA fast track program features, such as eligibility for rolling NDA submissions and priority review (if supported by clinical data at the time of NDA). Additionally, this designation provides more intensive involvement of FDA staff in a proactive, collaborative, cross-disciplinary review process. Setmelanotide is the first BTD to be awarded by FDA's Division of Metabolism and Endocrinology Products, which is responsible for obesity and diabetes indications.

Read more: http://www.prnewswire.com/news-releases/rhythm-receives-fda-breakthrough-therapy-designation-for-setmelanotide-for-treatment-of-pomc-deficiency-obesity-300200925.html

Source: Glide Technologies and reported by http://www.prnewswire.com/

OXFORD, England, January 6, 2016 /PRNewswire/ -- Glide Technologies, the development company focused on solid dose formulations of therapeutics and vaccines, today announced that the Company has successfully completed a pre-clinical proof-of-concept study with its novel solid dose formulation of exenatide, a GLP-1 agonist for the treatment of type 2 diabetes.  Results from the pharmacokinetic study show that there was no statistical difference (p<0.05) between Glide's solid dose formulation and the clinical dose of Byetta® (exenatide 10 mcg), the currently marketed liquid product.

Glide's solid dose formulations are designed to be delivered using the Company's self-administered, user-friendly, needle-free SDI® injector. The technology has multiple advantages over currently marketed liquid peptide products, which are needle administered and require cold chain logistics and refrigeration in the home. In particular, the technology has the potential to significantly improve patient compliance, which is important where self-administered injections are required, such as in diabetes.

The results follow previously announced successful proof-of-concept studies with Glide's novel solid dose formulations of currently marketed liquid products Forteo®/Forsteo® (teriparatide) and Sandostatin® (octreotide).  Consequently, Glide's solid dose formulation technology has now achieved equivalence across a series of peptide products, demonstrating the flexibility of the platform to deliver this important class of therapeutics.

Read more: http://www.prnewswire.com/news-releases/glide-technologies-announces-successful-proof-of-concept-with-novel-exenatide-solid-dose-formulation-564345691.html

Source: http://www.allegroeye.com/

Read more: http://www.allegroeye.com/press-release/allegro-ophthalmics-announces-last-patient-enrolled-in-del-mar-phase-2b-clinical-trial-of-luminate-for-the-treatment-of-diabetic-macular-edema/

Source: http://www.cjnews.com/

MONTREAL – Investigators at the Jewish General Hospital’s (JGH) Lady Davis Institute and the McGill University Health Centre (MUHC) have begun clinical trials that they say may revolutionize the treatment of Type 1 diabetes.

The therapy, pioneered by Dr. Lawrence Rosenberg, aims to regenerate islet cells in the pancreas, thereby restoring normal insulin secretion.

The treatment combines a peptide-based drug, developed by Minneapolis-based pharmaceutical company Exsulin Corporation, which stimulates the growth of insulin-producing cells, and ustekinumab (marketed under the trademark Stelera), an immunosuppressant drug approved for the treatment of psoriasis.   

The discovery of the INGAP (islet neogenesis-associated protein) peptide is the result of years of research by Rosenberg, a professor of surgery and medicine at McGill University and, since April, president and CEO of the Integrated Health and Social Services University Network for West-Central Montreal, and his collaborator Dr. Aaron Vinik, director of research and Murray Waitzer Endowed Chair for Diabetes Research at the Eastern Virginia Medical School (EVMS). 

Read more: http://www.cjnews.com/living-jewish/health/revolutionary-treatment-of-type-1-diabetes-in-clinical-trials

Source: http://www.theaustralian.com.au/

Formerly known as Calzada, PolyNovo has won approval from the US Food & Drug Administration to sell NovoSorb, a temporary lattice inserted ahead of an eventual skin graft.

Developed by the CSIRO, NovoSorb is a foam-like sheet that is stapled to the affected area, to encourage the regrowth of normal skin cells. Unlike the prevailing treatment, the burnt area can be unrecognisable from the surrounding skin.

PolyNovo chairman David Williams said the next step was finding a big distribution partner for the product, which will compete in an $US800 million ($1bn) a year market. He said PolyNovo was also pursuing potential applications for a wider $US8bn market including treating diabetic ulcers, hernias and breast implants. “There are some really big markets we are playing around with.’’

Read more: http://www.theaustralian.com.au/business/companies/polynovo-wins-us-fda-approval-for-burns-treatment-novosorb/news-story/15791fa080a4ca42538d45fd2a1a885d

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

WARRINGTON, Pa., Dec. 29, 2015 /PRNewswire/ -- Discovery Laboratories, Inc. (NASDAQ: DSCO), a biotechnology company focused on developing aerosolized KL4 surfactant therapies for respiratory diseases, today announced that it has initiated its AEROSURF® phase 2b clinical trial in premature infants 26 to 32 weeks gestational age (GA) receiving non-invasive nasal continuous positive airway pressure (nCPAP) for respiratory distress syndrome (RDS). The trial is designed to evaluate premature infants receiving aerosolized KL4 surfactant (including potentially repeat doses) compared to nCPAP alone.  Two dose groups will be evaluated. The primary objective of the trial is to demonstrate evidence of efficacy and, if successful, inform the design of a phase 3 clinical program.

"Currently, surfactant therapy is primarily administered to premature infants with RDS via invasive endotracheal intubation. The trend in neonatology is to use less- or non-invasive methods to treat RDS but these preclude the administration of surfactant therapy in a timely manner. AEROSURF allows for non-invasive delivery of aerosolized KL4 surfactant to premature infants receiving nCPAP," commented Steve Simonson, M.D., Discovery Labs' Chief Development Officer. "The initiation of the phase 2b trial is an important next step to build upon the results observed in our recently completed phase 2a clinical trials in premature infants 29 to 34 weeks GA. Data from these trials are encouraging and suggest that AEROSURF may reduce the incidence of nCPAP failure and the need for intubation and delayed surfactant therapy. If this result is confirmed as we advance our development program, AEROSURF could represent a significant medical advancement in neonatology."

Read more: http://www.prnewswire.com/news-releases/discovery-labs-announces-initiation-of-aerosurf-phase-2b-clinical-trial-300197647.html

Source: http://globenewswire.com/

NEWARK, Calif., Dec. 23, 2015 (GLOBE NEWSWIRE) -- Revance Therapeutics, Inc. (NASDAQ:RVNC), a specialty biopharmaceutical company developing botulinum toxin products for use in aesthetic and therapeutic indications, today announced interim efficacy and safety results from its Phase 2 trial of its RT001 topical botulinum toxin type A investigational drug product candidate for the treatment of axillary hyperhidrosis (excessive underarm sweating).  The trial was designed to evaluate safety and efficacy of two doses of RT001 applied on a single day of treatment.  Although the trial sample size was not chosen to meet statistical significance, using quantitative gravimetric measurements, the data was positive and showed that a single treatment of RT001 topical gel achieved clinically meaningful efficacy at Week 4.  Using the qualitative Hyperhidrosis Disease Severity Scale (HDSS), RT001 showed a strong efficacy trend for both 1-point and 2-point improvement. Both doses of RT001 appear to be safe and well tolerated.

“We are very pleased with the Phase 2 interim results, which provide strong clinical evidence establishing RT001’s ability to safely deliver botulinum toxin topically to reduce the severity and quantity of underarm sweat production,” said Dan Browne, President and Chief Executive Officer at Revance. “Quantitatively, the gravimetric data shows clinically meaningful sweat reduction for both doses of RT001 and, at the higher dose, RT001 was statistically significant versus placebo.  While the qualitative self-assessment by HDSS showed a notable placebo effect between Week 2 and Week 4, we believe that, overall, the RT001 data in this study are highly meaningful from a clinical standpoint.”

Mr. Browne added, “We plan to advance RT001 into a larger, well-powered hyperhidrosis Phase 2 study in 2016, which will be designed to confirm a final dose. Upon successful completion, we will then meet with the FDA to take RT001 into Phase 3 studies.”

Read more: http://globenewswire.com/news-release/2015/12/23/798059/0/en/Revance-Announces-Positive-Phase-2-Results-for-RT001-Botulinum-Toxin-Type-A-Topical-Gel-to-Treat-Axillary-Hyperhidrosis.html