All posts in Peptide News from Biotech and Pharma

Source: Amgen and reported by http://www.prnewswire.com/
THOUSAND OAKS, Calif., Sept. 27, 2016 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced top-line results of the Phase 3 CLARION trial, which evaluated an investigational regimen of KYPROLIS® (carfilzomib), melphalan and prednisone (KMP) versus Velcade® (bortezomib), melphalan and prednisone (VMP) for 54 weeks in patients with newly diagnosed multiple myeloma who were ineligible for hematopoietic stem-cell transplant. The trial did not meet the primary endpoint of superiority in progression-free survival (PFS) (median PFS 22.3 months for KMP versus 22.1 months for VMP, HR = 0.91, 95 percent CI, 0.75 - 1.10). While the data for overall survival, a secondary endpoint, are not yet mature, the observed hazard ratio (KMP versus VMP) was 1.21 (95 percent CI, 0.90 - 1.64). Neither result was statistically significant.

Overall, the adverse events in the KMP arm were consistent with the known safety profile of KYPROLIS. The incidence of Grade 3 or higher adverse events was 74.7 percent in the KMP arm and 76.2 percent in the VMP arm. Fatal treatment-emergent adverse events occurred in 6.5 percent of KMP patients and 4.3 percent of VMP patients. The incidence of Grade 2 or higher peripheral neuropathy, a secondary endpoint, was 2.5 percent in the KMP arm and 35.1 percent in the VMP arm.
Read more: http://www.prnewswire.com/news-releases/amgen-announces-top-line-results-from-phase-3-kyprolis-carfilzomib-clarion-study-in-newly-diagnosed-multiple-myeloma-patients-300334540.html

Source: http://www.businesswire.com/
BEIJING--(BUSINESS WIRE)--CANbridge Life Sciences, a biopharmaceutical company focused on developing Western drug candidates in China and North Asia, announced that the first patient was dosed in the Phase I/II trial of its lead candidate, CAN-008, for the treatment of newly-diagnosed glioblastoma multiforme (GBM), in Taiwan. The patient was treated at Linkou Chang Gung Memorial Hospital, in Taipei, Taiwan. CAN-008, CANbridge’s lead candidate, is an immunotherapy that enhances the immune system response to cancer and inhibits tumor cell growth. The study design consists of an open-label, dose-escalation Phase I trial, and a multi-center, double-blind, randomized, placebo-controlled Phase II trial. The Phase I trial will evaluate safety, tolerability, pharmacokinetics and preliminary efficacy. The Phase II trial will evaluate efficacy and safety. The combined Phase I/II trial will enroll a total of 55 patients. CANbridge expects to report Phase I safety data after mid-2017.
“CANbridge is now a clinical stage company, delivering on our mission to develop Western drug candidates for Asian markets,” said James Xue, CANbridge CEO. “It is of particular value to us that CAN-008 shows promise in glioblastoma multiforme, a terrible cancer that has had no new front-line treatments approved, anywhere in the world, since 1999. We are proud to bring a potentially new treatment option to this underserved group of patients.”
Read more: http://www.businesswire.com/news/home/20160926005368/en/Patient-Dosed-CANbridge%E2%80%99s-CAN-008-Phase-III-Trial

Source: https://globenewswire.com/
PHILADELPHIA and HOUSTON, United States and OXFORD, United Kingdom, Sept. 26, 2016 (GLOBE NEWSWIRE) -- Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, and The University of Texas MD Anderson Cancer Center announced today that they have entered into a multi-year strategic alliance designed to expedite the development of novel adoptive T-cell therapies for multiple types of cancer.

The alliance pairs MD Anderson’s preclinical and clinical teams with Adaptimmune’s scientists and proprietary SPEAR® (Specific Peptide Enhanced Affinity Receptor) T-cell technology platform, which enables Adaptimmune to identify targets expressed on solid and hematologic cancers and to develop affinity enhanced T-cell receptors (TCRs) with optimal potency and specificity against them.

The teams will collaborate in a number of areas including preclinical and clinical development of Adaptimmune’s SPEAR T-cell therapies targeting MAGE-A10 and future clinical stage first and second generation SPEAR T-cell therapies such as MAGE-A4 across a number of cancers, including bladder, lung, ovarian, head and neck, melanoma, esophageal and gastric cancers. The alliance will also drive research and development of other new SPEAR TCR therapies to targets in other tumor types such as breast cancers and facilitate clinical study participation by MD Anderson in other Adaptimmune trials. Access to MD Anderson’s tumor repository will guide further target selection and clinical trial design, while its cancer immunology cores and expertise in performing translational medicine studies may help optimize the efficacy and safety of SPEAR T-cell therapies.
Read more: https://globenewswire.com/news-release/2016/09/26/874501/0/en/MD-Anderson-Cancer-Center-and-Adaptimmune-Form-Strategic-Alliance-to-Advance-Development-of-Immunotherapies-Targeting-Multiple-Cancers.html

Source: http://www.dgap.de/
Pamplona, Spain, 26. September 2016 - Cinfa Biotech S.L., the biosimilars company of Infarco group, today announced the start of the second clinical study with its lead development candidate B12019, a biosimilar version of Neulasta(R) (pegfilgrastim) to treat chemotherapy-induced neutropenia. The objective of the trial is to investigate the pharmacodynamics (PD) and immunogenicity of B12019 compared to Neulasta(R).
The multiple-dose, randomised, double-blind, cross-over study will enrol 96 healthy volunteers in Germany. Secondary endpoints of the trial include pharmacokinetic (PK) and safety parameters. The study design is based on scientific advice from the European Medicines Agency (EMA) and is tailored to the specific properties of pegfilgrastim.
Dr. Ruediger Jankowsky, Managing Director of Cinfa Biotech GmbH, commented: "The successful clinical trial of B12019, which we reported in July this year, allowed for the immediate continuation of the clinical development program, especially since proving that we have such a high-quality product and a confirmed development strategy. The timely start of the second clinical study marks an important milestone in the development of B12019."
Read more: http://www.dgap.de/dgap/News/corporate/cinfa-biotech-starts-second-clinical-study-pegfilgrastim-biosimilar-candidate-b/?newsID=963037

Source: Palatin Technologies, Inc. and reported by http://www.prnewswire.com/
CRANBURY, N.J., Sept. 23, 2016 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE MKT: PTN), a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical need and commercial potential, announced that a review of the neurobiology and treatment efficacy of bremelanotide for hypoactive sexual desire disorder ("HSDD") was presented at the International Society for Sexual Medicine 20th World Meeting in Beijing, China.
Anita H. Clayton, M.D., of the University of Virginia School of Medicine, is lead author on the poster entitled "Bremelanotide: A Review of Its Neurobiology and Treatment Efficacy for HSDD." The poster addresses mechanisms of sexual response and the pathophysiology of HSDD, and describes the potential of bremelanotide to modulate brain pathways involved in sexual response.
James G. Pfaus, Ph.D., of Concordia University in Montreal, Canada was co-author, together with Johna Lucas, M.D., Carl Spana, Ph.D. and Robert Jordan of Palatin.
Palatin is developing bremelanotide, a centrally-mediated medication, as a subcutaneous, on-demand treatment for premenopausal women diagnosed with HSDD. Bremelanotide, which is a melanocortin 4 receptor agonist drug candidate, is a synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone).
Read more: http://www.prnewswire.com/news-releases/palatin-technologies-presents-bremelanotide-neurobiology-and-treatment-efficacy-review-at-world-meeting-on-sexual-medicine-300332936.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://www.pasadenanow.com/
A pharmaceuticals company based in Pasadena announced today that a drug they are developing to combat neurodegenerative disorders has successfully slowed down the progression of ALS in a clinical test and can modify genes associated with the nervous system.
ALS, amyotrophic lateral sclerosis, is a progressive neurodegenerative disease that affects nerve cells in the brain and the spinal cord.
Genervon Biopharmaceuticals provided data to an external contract research organization that confirmed the drug — known as GM6 — can edit genes in the nervous system that have an impact on defense against stress and upkeep of cellular balance, according to a statement released to the media.
About 1,200 genes showed a strong response to GM6 treatment, based on the most stringent of statistical thresholds, according to the press release. Using a less conservative criteria, approximately 3,000 genes showed change.
These numbers affirm that GM6 has major regulatory effects in neuronal cells and can be classified as a “master regulator” of the human CNS, according to the media statement.
Read more: http://www.pasadenanow.com/main/pasadena-drug-company-says-their-successfully-slows-down-progression-als/#.WB9gBC0rK1s

Source: http://www.marketwired.com/
SAN DIEGO, CA--(Marketwired - September 22, 2016) - Aegis Therapeutics LLC announced today that it has been awarded U.S. Patent No. 9,446,134 providing non-invasive metered nasal spray delivery of octreotide. Currently, octreotide is administered by injection three times per day or in a long acting injectable form to treat acromegaly, flushing episodes and watery diarrhea caused by cancerous tumors (carcinoid syndrome or VIP adenomas). The long acting injectable forms, which are typically administered by healthcare professionals, are associated with pain and irritation at the injection site. According to a comprehensive discussion of current practices of octreotide administration that appeared in BioCentury, Feb. 18, 2013, pp. A8-A9, the long acting forms of octreotide "are administered with large-bore needles that penetrate up to two inches beneath the skin and remain in place 45-120 seconds to deliver the dose, causing pain and discomfort during and long after the injection."
The enabling Aegis Intravail formulation technology is broadly applicable to a wide range of small molecule and biotherapeutic drugs to increase noninvasive bioavailability by the oral, nasal, buccal, and sublingual routes and to speed attainment of therapeutic drug levels in cases where a non-invasive (i.e., non-injectable) form of the drug is unavailable or where speed of onset is important, for example in the treatment of pain, nausea, emesis, convulsive disorders, spasticity, and the like.
Read more: http://www.marketwired.com/press-release/aegis-awarded-patent-for-non-invasive-nasal-octreotide-formulation-2160633.htm

Source: http://www.prnewswire.co.uk/
MADRID, September 22, 2016 /PRNewswire/ -- PharmaMar (MSE:PHM) has announced today the submission to the European Medicines Agency (EMA) of the Marketing Authorization Application (MAA) for Aplidin® (plitidepsin) in combination with dexamethasone for the treatment of relapsed/refractory multiple myeloma (MM). This is a type of blood cancer which represents 10% of all hematological malignancies.
PharmaMar has gone through with this application given the positive data obtained from the randomized, Phase III ADMYRE clinical trial, where the efficacy and safety of Aplidin® with dexamethasone versus dexamethasone alone in patients with relapsed/refractory MM after at least three, but no more than six, prior therapeutic regimens has been evaluated. The results of the ADMYRE study showed a statistically significant 35% reduction in the risk of progression or death over the comparator. The study met its primary endpoint.
The submission of this MMA to the EMA represents an important milestone for PharmaMar. "We have achieved positive results with this molecule throughout its clinical development and we believe Aplidin® could become a novel therapeutic alternative for patients with multiple myeloma", says Luis Mora, Managing Director of PharmaMar´s Oncology Business Unit, who also adds "that we estimate the answer from the regulatory agency for the second half of 2017".
Read more: http://www.prnewswire.co.uk/news-releases/pharmamar-submits-maa-to-ema-for-aplidin-for-the-treatment-of-multiple-myeloma-594387731.html