DiaMedica Therapeutics announced the publication of a paper in the peer reviewed journal, Therapeutic Advances in Neurological Disorders, or TAND. The paper summarizes the mechanistic rationale for using KLK1 to treat patients with acute ischemic stroke, or AIS, and summarizes human preclinical and clinical data supporting the hypothesis that KLK1 treatments may improve outcomes after AIS. KLK1, is a serine protease that plays a critical role in the regulation of microcirculation, blood pressure and blood flow. Multiple lines of evidence indicate that KLK1 is important for a healthy cardiovascular system and that deficits in KLK1 are associated with cardiovascular and end-organ pathology. Importantly, KLK1 replenishment therapy is widely used in Asia where multiple forms are used to treat diseases ranging from AIS to complications of diabetes. These diseases involve poor microcirculation or tissue ischemia, which leads to a hypothesis that directly boosting KLK1 levels will improve blood flow and protect tissue under ischemic conditions. The TAND paper reviews the scientific literature covering the biochemical role of KLK1 and presents the mechanistic rationale for using KLK1 as an additional pharmacological treatment for AIS. In addition to the biochemical mechanism of KLK1, the review highlights supporting results from human genetics and preclinical animal models of brain ischemia. It also reviews published clinical results for treatment of AIS by a form of KLK1 that is isolated from human urine. This form has been approved for post-infarct treatment of AIS in the People’s Republic of China and data has been published on clinical trials involving over 4,000 patients. The paper offers a series of testable therapeutic hypotheses for demonstrating the long-term beneficial effect of KLK1 treatment in AIS patients and the reasons for this action.
Tuesday, January 22, 2019
Canaccord strongly recommends adding to STAAR Surgical, reiterates as Top Pick
Canaccord analyst Jason Mills strongly recommended investors add to STAAR Surgical positions as he reiterated it as a top small-cap pick for 2019. The analyst believes the company will produce elite revenue growth and gross margin in 2019 and possibly deliver upside to 2019 after “crushing expectations” in 2018. Mills noted the company is expanding production and augmenting its commercial footprint globally in preparation for an enormous, expected wave of ICL adoption both near and long-term. Mills reiterated his Buy rating and $40 price target on STAAR Surgical shares.
MacroGenics price target lowered to $20 from $44 at Wedbush
Wedbush analyst David Nierengarten lowered his price target for MacroGenics to $20 from $44 following recent clinical updates and company guidance. In 2019, the analyst looks forward to the pivotal Phase 3 SOPHIA readout this quarter, where he looks for topline PFS study results to support margetuximab use in 3L/4L metastatic breast cancer with BLA submission in 2H19. Nierengarten sees upside to his valuation in the range $2-$6 depending on the strength of the data, with downside in the range of $2-$4. The analyst also notes that recently updated margetuximab data in gastric cancer at ASCO GI, although somewhat deteriorated from ESMO, is still positive and warrants further 2L investigation in combination with anti PD-1 antibody. He reiterates an Outperform rating on the shares.
Cocrystal Pharma announces safety, preliminary efficacy data for CC-31244
Cocrystal Pharma (COCP) announced safety and preliminary efficacy data for its U.S. Phase 2a study evaluating CC-31244 for the ultra-short treatment of HCV infected individuals. CC-31244 is an investigational, oral, potent, broad-spectrum replication inhibitor called a non-nucleoside inhibitor, or NNI. Epclusa is an approved 12-week therapy for HCV developed by Gilead (GILD). The U.S. Phase 2a study is an open-label study designed to evaluate the safety, tolerability, and preliminary efficacy of CC-31244 with Epclusa in 12 subjects with treatment-naive HCV genotype 1. Subjects received oral 400 mg of CC-31244 and Epclusa for 2 weeks. Following this, the subjects continued Epclusa treatment alone for another 4 weeks. All subjects completed the 6-week treatment regimen. The treatment was well tolerated with no study discontinuations due to adverse events. Eight of 12 subjects achieved the primary efficacy endpoint of sustained virologic response at 12 weeks after completion of treatment, or SVR12. SVR12 is defined as undetectable virus in blood 12 weeks after completion of treatment and considered a virologic cure. Plans are underway to commence the second study in the HCV clinical development program, a Phase 2a study in Hong Kong evaluating the safety, tolerability and preliminary efficacy of CC-31244 in combination with sofosbuvir and daclatsavir with or without a protease inhibitor, for the treatment of hepatitis C. The Humanity & Health Research Centre expects to commence the study in Q1. The upcoming, Hong Kong Phase 2a open-label trial differs from the current Phase 2a trial Cocrystal is conducting by use of a protease inhibitor as part of the combination regimen and a shorter treatment duration.
Gamida Cell, Be The Match BioTherapies announce strategic collaboration
Gamida Cell and Be The Match BioTherapies, a subsidiary of the National Marrow Donor Program/Be The Match offering integrated platforms and software to manage the collection and delivery of cellular therapies, today announced a strategic collaboration to improve outcomes for patients undergoing allogeneic hematopoietic stem cell transplantation. The collaboration supports NiCord, Gamida Cell’s investigational cell therapy, which has the potential to serve as a universal bone marrow donor source for patients with hematologic malignancies, or blood cancers, and bone marrow failure disorders requiring bone marrow transplantation. Under the terms of the collaboration agreement, Gamida Cell and Be The Match BioTherapies will explore opportunities to work together across Gamida Cell’s ongoing clinical development program for NiCord, including the Phase 3 clinical study in patients with high-risk blood cancers. Be The Match BioTherapies has an extensive history of involvement in the delivery of cord blood units for transplant and broad access to cord blood banks globally. The collaboration is expected to leverage a wide range of Be The Match BioTherapies’ research assets and services, including the Be The Match Registry, the largest in the world with more than 20 million potential donors, as well as personalized case management and logistics services.
Ultragenyx: On track to submit NDA for UX007 in mid-2019
https://thefly.com/landingPageNews.php?id=2851597
BrainStorm granted additional patent for NurOwn in Israel
BrainStorm Cell Therapeutics announced that the Israel Patent Office has granted an additional patent titled “Methods of Generating Mesenchymal Stem Cells which Secrete Neurotrophic Factors.” The allowed claims cover the method of manufacturing the cells, the cells generated according to the method of manufacturing, and the use of the cells for preparation of a therapy for treating a disease, including a neurodegenerative disease, a neurological and an immune disease.
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