All posts in Peptide News from Biotech and Pharma

Source: https://globenewswire.com/

SAN RAMON, Calif., Jan. 05, 2017 (GLOBE NEWSWIRE) -- Galena Biopharma, Inc. (NASDAQ:GALE), a biopharmaceutical company committed to the development and commercialization of hematology and oncology therapeutics that address unmet medical needs, today provided a corporate and clinical outlook for 2017 and announced that Mark W. Schwartz, Ph.D., President and Chief Executive Officer will give a company presentation at the Biotech Showcase 2017. The presentation will take place on Wednesday, January 11, 2017 at 10:30 a.m. PT at the Hilton San Francisco Union Square. The presentation will be webcast and available on the Investors section of the Company's website at http://investors.galenabiopharma.com/events.cfm.

“2017 looks to be promising for Galena Biopharma as we prepare to initiate our Phase 3 clinical trial in patients with essential thrombocythemia (ET) with GALE-401, our controlled release version of anagrelide,” said Mark W. Schwartz, Ph.D., President and Chief Executive Officer. “After a productive meeting with the U.S. Food and Drug Administration (FDA) last month, we were pleased to confirm that the GALE-401 development program is appropriate for a New Drug Application (NDA) filing using the 505(b)(2) regulatory pathway in patients who are intolerant to or failed to achieve an optimal response with hydroxyurea. In the U.S., ET has a prevalence of approximately 150,000 people and we estimate up to 25% of those patients who receive initial treatment with hydroxyurea may be candidates for the GALE-401 trial. We expect to finalize the details of the Phase 3 clinical trial protocol including the trial size, endpoints, and dosing this quarter and initiate the trial in the second quarter of 2017.”

Read more: https://globenewswire.com/news-release/2017/01/05/903607/0/en/Galena-Biopharma-to-Provide-Corporate-and-Clinical-Update-and-2017-Outlook-During-Presentation-at-Biotech-Showcase-2017.html

Source: http://www.businesswire.com/
CHARLESTON, S.C.--(BUSINESS WIRE)--Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the “Company”) today announced that the confirmatory Phase 3 clinical trial of Macrilen™ (macimorelin) failed to achieve its objective of validating a single oral dose of macimorelin for the evaluation of growth hormone deficiency in adults (“AGHD”), using the insulin tolerance test (the “ITT”) as a comparator. The Company is evaluating the outcome of the trial and will determine in the near future whether it will continue with the development of Macrilen™.

Dr. Richard Sachse, the Company’s Chief Scientific Officer, stated, “We are, of course, very disappointed about the outcome of the trial. Based on an analysis of top-line data, macimorelin did not achieve equivalence to the ITT as a means of diagnosing AGHD. Under the study protocol, the evaluation of AGHD with Macrilen™ would be considered successful, if the lower bound of the two-sided 95% confidence interval for the primary efficacy variables was 75% or higher for “percent negative agreement” with the ITT, and 70% or higher for the “percent positive agreement” with the ITT. While the estimated percent negative agreement met the success criteria, the estimated percent positive agreement did not reach the criteria for a successful outcome. Therefore, the results did not meet the pre-defined equivalence criteria which required success for both the percent negative agreement and the percent positive agreement. After a thorough internal review and understanding of this data, the Company will decide upon the appropriate future course of action with respect to macimorelin.”

Read more: http://www.businesswire.com/news/home/20170104006480/en/Aeterna-Zentaris-Announces-Top-Line-Results-Confirmatory-Phase

Source: http://www.b3cnewswire.com/
Geneva, Switzerland, January 05, 2017 / B3C newswire / -- Xigen, a Swiss Company developing therapeutic peptides for the treatment of inflammatory diseases announces today the online publication of successful Phase II results for its lead compound Brimapitide (XG-102) in the American Journal of Ophthalmology.

Xigen’s innovative technology platform enables the design and synthesis of long-acting therapeutic peptides with a very high metabolic stability. The peptides, including the lead compound Brimapitide (XG-102), are designed to allow the efficient delivery of the active element to intracellular targets. In the case of Brimapitide this means the ability to selectively reach and inhibit c-Jun N-Terminal Kinase. Ophthalmology was chosen as a gateway to the treatment of more complex inflammatory diseases.

The phase II study of 145 patients was designed as a controlled, multi-center, randomized, double-blind, parallel-group study to assess the efficacy and safety of a single sub-conjunctival injection of Brimapitide (XG-102) in comparison with repeated administration of dexamethasone eye drops in post-surgical intraocular inflammation. The study took place in France in six referral centers in the field of Ophthalmology in Paris, Grenoble, Dijon, Nancy, and Lyon. The overall development of Xigen’s lead product was carried out by Solid Drug Development SA, a specialized firm based in Geneva.

Read more: http://www.b3cnewswire.com/201701051515/xigens-brimapitide-an-innovative-jnk-inhibitor-delivers-positive-phase-ii-results-in-inflammatory-eye-disease.html

Source: http://www.businesswire.com/
WATERTOWN, Mass.--(BUSINESS WIRE)--Tarveda Therapeutics, Inc., a biopharmaceutical company discovering and developing Pentarins™ as a new class of potent and selective anti-cancer medicines, today announced that a Phase 1/2a clinical trial evaluating PEN-221 in patients with advanced neuroendocrine tumors and small cell lung cancer expressing the somatostatin receptor 2 (SSTR2) is underway, with patients enrolled and treated. The somatostatin receptor is highly expressed in neuroendocrine cancers. PEN-221 is a novel, miniaturized drug conjugate designed to selectively target SSTR2 and then internalize and release its potent DM1 payload in the tumor cell.

“Pentarins are engineered to rapidly penetrate and kill solid tumors that have proven challenging for treatment modalities such as antibody drug conjugates and chemotherapeutics,” said Gordon B. Mills, M.D., Ph.D., Professor and Chair, Department of Systems Biology, at The University of Texas MD Anderson Cancer Center, Houston, TX. “The miniaturized size, unique design and potent payloads of Pentarins allow for sustained payload release in solid tumors to drive potential efficacy while sparing normal tissue.

Read more: http://www.businesswire.com/news/home/20170104005507/en/Tarveda-Therapeutics-Announces-Phase-12a-Clinical-Trial

Source: https://www.astrazeneca.com/
AstraZeneca and Eli Lilly and Company today announced a worldwide agreement to co-develop MEDI1814, an antibody selective for amyloid-beta 42 (Aβ42), which is currently in Phase I trials as a potential disease-modifying treatment for Alzheimer’s disease (AD). This agreement builds on the existing collaboration related to AZD3293, a BACE inhibitor in two pivotal Phase III trials.

The build-up of plaques in the brain containing the peptide amyloid-beta (Aβ) is one of the characteristics of AD. MEDI1814 binds selectively to Aβ42, a form of Aβ which is particularly associated with the disease. MEDI1814 dose-dependently reduces levels of this peptide, potentially slowing the progression of AD.

Mene Pangalos, Executive Vice President, IMED Biotech Unit and Business Development, AstraZeneca, said: “We are excited to build on an already productive collaboration with Lilly, which combines the expertise of our two companies, with a new programme focused on the amyloid beta pathway. MEDI1814 has a unique mechanism among antibodies in clinical development and could provide a distinct approach to treating Alzheimer’s disease.”

Read more: https://www.astrazeneca.com/media-centre/press-releases/2016/Astrazeneca-and-Lilly-to-develop-second-potentially-disease-modifying-treatment-for-alzheimers-disease-09122016.html

Source: OPKO Health Inc. & reported by https://globenewswire.com/
MIAMI, Dec. 30, 2016 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) announced it has commenced data analysis in the phase 3, double-blind, placebo-controlled study of its investigational long-acting human growth hormone product (hGH-CTP) in adults with growth hormone deficiency (GHD). The multinational, multi-center study, which utilized a 2:1 randomization between hGH-CTP and placebo, enrolled 203 subjects, 198 of whom received at least one dose of study treatment. Treatment was administered through a weekly injection.

On the primary endpoint of change in trunk fat mass from baseline to 26 weeks, there was no statistical difference between hGH-CTP and placebo. However, after unblinding the study, OPKO identified one or more outliers that may have affected the primary outcome. As a result, OPKO is undertaking further review of the study population as promptly as possible. The safety profile observed in this study was consistent with that known for growth hormone treatments. A greater percentage of subjects on hGH-CTP normalized serum concentrations of insulin-like growth factor-I compared to placebo. Additional efficacy and safety data and analyses from the study will be released once available.

Read more: https://globenewswire.com/news-release/2016/12/30/902328/0/en/OPKO-Health-Provides-Update-on-hGH-CTP-Clinical-Programs.html

Source: http://www.soricimed.com/
TORONTO, Canada, September 27, 2016 – Soricimed Biopharma Inc. ("Soricimed"), a clinical-stage pharmaceutical company discovering and developing peptide-based cancer therapeutics, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to peptide SOR-C13 for the treatment of pancreatic cancer. This follows the same designation for ovarian cancer.
Orphan drug status is granted following review of the rarity and severity of the medical condition, as well as the potential benefit of the product treating this condition. Orphan drug status qualifies Soricimed for various development incentives, including tax credits and reduced filing fees for clinical trials undertaken in the U.S. If approved for commercialization by the FDA, SOR-C13 may qualify for seven years of marketing exclusivity in the United States for this indication. In some cases, orphan drugs can be made available to patients before marketing approval on a compassionate use basis.
Pancreatic cancer remains one of the world’s deadliest cancers, with a five-year survival rate of eight percent. According to the Cancer research Institute, each year more than 337,000 people worldwide are diagnosed with pancreatic cancer and more than 330,000 people die from the disease. While pancreatic cancer is the eleventh most common cancer in the United States, it is now the third leading cause of cancer-related death. Each year more than 53,070 people in the United States will be diagnosed with pancreatic cancer, and more than 41,780 will die.
Read more: http://www.soricimed.com/news/soricimed%E2%80%99s-sor-c13-granted-orphan-drug-designation-pancreatic-cancer-us-fda

Source: http://ir.adaptimmune.com/
Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, today announced that its amended protocol using its NY-ESO SPEAR® (Specific Peptide Enhanced Affinity Receptor) T-cell therapy in ovarian cancer patients with treatment resistant or refractory metastatic ovarian cancer is now actively recruiting.
To date, no objective clinical responses have been reported in the ovarian cancer patients who received NY-ESO SPEAR T-cell therapy in the initial iteration of this trial. Of note, these initial patients received a preconditioning regimen which consisted of cyclophosphamide alone, rather than including fludarabine. Data from Adaptimmune’s studies of its NY-ESO SPEAR T-cell therapy in synovial sarcoma patients have indicated the importance of including fludarabine in the preconditioning regimen. The use of fludarabine appears to be required for expansion, response and persistence of transduced cells. As a result, this trial will enroll patients under a revised protocol including a pre-conditioning regimen that includes fludarabine in combination with cyclophosphamide.
"Based on our clinical experience to date, we have amended the protocol for this trial to include both fludarabine and cyclophosphamide in the conditioning regimen," said Dr. Rafael Amado, Adaptimmune’s Chief Medical Officer. “We hope that, as previously observed in synovial sarcoma, this lymphodepleting regimen will enable anti-tumor immune responses mediated by NY-ESO SPEAR T-cell therapy in these patients with advanced chemotherapy relapsed or refractory ovarian cancer."
Read more: http://ir.adaptimmune.com/phoenix.zhtml?c=253991&p=irol-newsArticle&ID=2211163

Source: http://www.allegroeye.com/
SAN JUAN CAPISTRANO, CA — October 3, 2016 — Allegro Ophthalmics, LLC, a biotechnology company focused on the development of therapies to treat vitreoretinal diseases, today announced completion of enrollment in its PACIFIC Phase 2b clinical trial that is evaluating the safety and efficacy of Luminate® (ALG-1001) in inducing posterior vitreous detachment (PVD) in patients with non-proliferative diabetic retinopathy (DR).

“We are very pleased to have completed patient enrollment in the PACIFIC trial,” said Vicken Karageozian, M.D., President and Chief Medical Officer, Allegro Ophthalmics. “There are currently no practical treatment options available for PVD induction in non-proliferative DR, resulting in a significant need for novel, non-surgical treatments that optimize long-term clinical outcomes. We are optimistic that Luminate will continue to show efficacy and provide meaningful therapeutic benefit to patients with diabetic retinopathy and other vitreoretinal diseases.”

PACIFIC is the third Phase 2 study of Luminate to complete enrollment. Top-line results from PACIFIC are anticipated to be available within the first half of 2017, and those from the DEL MAR Phase 2b trials evaluating Luminate in patients with diabetic macular edema (DME) are expected Q4 2016.
Read more: http://www.allegroeye.com/press-release/allegro-ophthalmics-announces-last-patient-enrolled-in-pacific-phase-2b-clinical-trial-of-luminate-for-non-proliferative-diabetic-retinopathy/