FDA Fast Track’s Prevail’s PROO1 for Parkinson’s; shares up 12% premarket – Seeking Alpha

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• Prevail lands on a Lilly pad December 15, 2020 # # # # 2020 has been a dreadful year for most of the world – burdened by the outbreak and consequences of COVID-19. Despite this, there has been a steady stream of biotech acquisitions related to Parkinson’s which have helped to keep morale high in the PD research community. In October alone, we saw the Portuguese pharmaceutical company Bial…
• The road ahead: 2020 January 5, 2020 Here at the SoPD, we are primarily interested in disease modification for Parkinson’s. While there is a great deal of interesting research exploring the causes of the condition, novel symptomatic therapies, and other aspects of Parkinson’s, my focus is generally on the science seeking to slow, stop or reverse the condition. At the start of each year, it is a…
• Shining a light on Parkinson’s November 7, 2019   NOTE: The information in today’s post should not be considered an endorsement of PhotoPharmics or the treatment they are proposing. The author of this blog has had no communication with the company. The information in this post is provided because the author has been asked by readers to discuss it. In October 2018, at the annual International Movement Disorders…
• Enrollment Ongoing in PROPEL Trial for Prevail’s Gene Therapy PR001 March 9, 2020 Enrollment in the Phase 1/2 PROPEL trial, evaluating the safety, tolerability, and early efficacy of PR001 — a one-time gene therapy — for Parkinson’s disease associated with mutations in the GBA1 gene, is progressing at two centers in New York and patient dosing is continuing. Prevail Therapeutics, which is developing the therapy, expects to present early interim results in the second…
• Monthly Research Review – September 2019 September 30, 2019   At the end of each month the SoPD writes a post which provides an overview of some of the major pieces of Parkinson’s-related research that were made available during September 2019. The post is divided into seven parts based on the type of research: Basic biology Disease mechanism Clinical research New clinical trials Clinical trial news Other news Review…
• Prevail’s Gene Therapy Candidate PR001 Granted FDA Fast Track Status July 10, 2019 The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Prevail Therapeutics’ lead gene therapy candidate, PR001, for the treatment of people with Parkinson’s disease associated with GBA1 gene mutations. Fast Track status will support and expedite the clinical development, regulatory review, and potential marketing approval of PR001. The FDA’s decision follows its acceptance of Prevail’s Investigational New…
• 2019: Year in review December 31, 2019   In this end-of-year post, we review the Parkinson’s research that caught our attention at SoPD HQ in 2019. Month-by-month we will briefly discuss some of the major pieces of research/announcements that have defined the year and advanced our understanding of Parkinson’s. The list is based on nothing more than the author’s personal opinion – apologies to any researchers who…
• Monthly research review – October 2019 October 31, 2019   At the end of each month the SoPD writes a post which provides an overview of some of the major pieces of Parkinson’s-related research that were made available during October 2019. The post is divided into seven parts based on the type of research: Basic biology Disease mechanism Clinical research New clinical trials Clinical trial news Other news Review…
• Bayer doubles down on Parkinson’s? December 10, 2020 # # # # News today of two biotech companies merging did not cause much of a ripple in the media, but the wider implications of the move are rather significant for Parkinson’s. Today it was announced that Brain Neurotherapy Bio (BNB) is going to merge with Asklepios Biopharmaceutical (aka AskBio). BNB are currently clinically testing a GDNF gene therapy…
• Monthly Research Review – December 2020 December 31, 2020   At the end of each month the SoPD writes a post which provides an overview of some of the major pieces of Parkinson’s-related research that were made available during December 2020. The post is divided into seven parts based on the type of research: Basic biology Disease mechanism Clinical research New clinical trials Clinical trial news Conferences/lectures Other news…
• Early Trial for Prevail’s One-time Gene Therapy PR001 to Start Soon September 12, 2019 Prevail Therapeutics will soon start its Phase 1/2 clinical trial evaluating the safety, tolerability, and early efficacy of its one-time gene therapy — called PR001 — for Parkinson’s disease associated with mutations in the GBA1 gene. The trial is expected to enroll up to 16 people with confirmed GBA1 mutations. Participants will be randomly assigned to receive two escalating doses of PR001, or…
• Monthy research review – December 2019 December 30, 2019   At the end of each month the SoPD writes a post which provides an overview of some of the major pieces of Parkinson’s-related research that were made available during December 2019. The post is divided into seven parts based on the type of research: Basic biology Disease mechanism Clinical research New clinical trials Clinical trial news Other news Review…
• Monthly Research Review – November 2019 November 30, 2019   At the end of each month the SoPD writes a post which provides an overview of some of the major pieces of Parkinson’s-related research that were made available during November 2019. The post is divided into seven parts based on the type of research: Basic biology Disease mechanism Clinical research New clinical trials Clinical trial news Other news Review…
• Monthly research review: February 2020 February 29, 2020   At the end of each month the SoPD writes a post which provides an overview of some of the major pieces of Parkinson’s-related research that were made available during February 2020. The post is divided into seven parts based on the type of research: Basic biology Disease mechanism Clinical research New clinical trials Clinical trial news Other news Review…
• Monthly Research Review – August 2019 August 31, 2019   At the end of each month the SoPD writes a post which provides an overview of some of the major pieces of Parkinson’s-related research that were made available during August 2019. The post is divided into seven parts based on the type of research: Basic biology Disease mechanism Clinical research New clinical trials Clinical trial news Other news Review…
• Monthly Research Review: Jaunary 2020 January 31, 2020   At the end of each month the SoPD writes a post which provides an overview of some of the major pieces of Parkinson’s-related research that were made available during January 2020. The post is divided into seven parts based on the type of research: Basic biology, Disease mechanism, Clinical research, New clinical trials, Clinical trial news, Other news, and…
• Monthly Research Review – November 2020 November 30, 2020   At the end of each month the SoPD writes a post which provides an overview of some of the major pieces of Parkinson’s-related research that were made available during November 2020. The post is divided into seven parts based on the type of research: Basic biology Disease mechanism Clinical research New clinical trials Clinical trial news Conferences/lectures Other news…
• 2020: Year in Review January 1, 2021 # # # # In this end-of-year post, we review the Parkinson’s research that caught our attention at SoPD HQ in 2020. Month-by-month we will briefly discuss some of the major pieces of research/ announcements that have defined the year and advanced our understanding of Parkinson’s. The list is based on nothing more than the author’s personal opinion – apologies…
• Say it with me: Farn-e-syl-trans-fer-ase October 24, 2019 ng   Not a week goes by without some new peice of research suggesting yet another biological mechanism that could be useful in slowing or stopping Parkinson’s. This week researchers in Chicago reported that pharmacologically inhibiting a specific enzyme – farnesyltransferase – may represent a novel means of boosting waste disposal and helping stressed cells to survive. A number of…
• That time APOE met Alpha Syn February 10, 2020    Recently two independent research groups published scientific papers providing evidence that a genetic variation associated with Alzheimer’s may also be affecting the severity of pathology in Parkinson’s. The genetic variation associated with Alzheimer’s occurs in a gene (a functional region of DNA) called ApoE, and the Parkinson’s pathology involves the clustering of a protein called alpha synuclein. Specifically, both…
• Potential One-time Gene Therapy for Parkinson’s Linked to GBA Mutations to Enter Clinical Trial June 11, 2019 A potential gene therapy for Parkinson’s disease associated with mutations in the GBA1 gene, PR001, will move into clinical testing in patients after the U.S. Food and Drug Administration (FDA) accepted an application for the therapy, Prevail Therapeutics announced. FDA acceptance of the company’s Investigational New Drug (IND) application allows Prevail to initiate a Phase 1/2 clinical trial assessing PR001’s safety…
• DNA repair: Alpha synuclein to the rescue September 10, 2019   For the last 21 years, the protein alpha synuclein has developed a reputation as public enemy #1 in the world of Parkinson’s. Tiny errors in the DNA that provides the instructions from making the alpha synuclein protein were found to be the first genetic risk factor for the condition, and then the protein itself was found to be present…