MLD granted second Pre-IND meeting with the FDA for PPI-1040 and treatment of RCDP

SASKATOON, SK, CANADA. MLD, a developer of advanced plasmalogen-based therapeutic products, is pleased to announce that it has been granted a second Type B pre-IND meeting with the FDA to discuss details surrounding the development of PPI-1040 for the treatment of RCDP. The meeting is scheduled for the last week in January, 2019, and focuses specifically on the proposed nonclinical development plan. "This meeting represents another step towards the ultimate goal of improving the lives of patients with RCDP," says Dr. Tara Smith, VP of Therapeutics, "and we are looking forward to the FDA's feedback on our proposed animal studies, and beginning the nonclinical safety and pharmacology program this coming year."


About MLD

MLD is a Canadian health prevention company developing novel plasmalogen replacement compounds for the treatment of various disorders associated with plasmalogen deficiency, including RCDP, Alzheimer's disease, Parkinson's disease, and Multiple Sclerosis, as well as companion screening tests that detect metabolic risk for chronic diseases including neurodegenerative disorders and cancer.

MLD's Safe Harbor Statement
This document may contain “forward-looking statements” within the meaning of Canadian securities legislation. The words “may”, “will”, “could”, “should”, “would”, “suspect”, “outlook”, “believe”, “plan”, “anticipate”, “estimate”, “expect”, “intend”, “forecast”, “objective”, and “continue” (or the negative thereof), and words and expressions of similar import, are intended to identify forward-looking statements. Forward-looking statements contained in this release are necessarily based on assumptions and information that, while considered reasonable to us, are inherently uncertain. Readers should not place undue reliance on any forward-looking statements. When reviewing our forward-looking statements, investors and others should carefully consider the foregoing factors and other uncertainties and potential events. Except as required by Canadian securities law, we do not undertake to update any forward-looking statements, whether written or oral, that may be made from time to time by us or on our behalf; such statements speak only as of the date made.

MLD presenting on RCDP at the World Orphan Drug Congress, 2019.

MLD is please to announce that Dr. Shawn Ritchie, CEO and Chief Scientific Officer, will be presenting at the World Orphan Drug Congress in Oxon Hill, Maryland, April 12, 2019. The talk is titled "Synthetic plasmalogen precursor PPI-1040 for the treatment of Rhizomelic Chondrodysplasia Punctata (RCDP) and other rare pediatric peroxisomal disorders." More information about the conference can be found here.


MLD attending JP Morgan Biotech Showcase

MLD will be in San Francisco January 7 through 10th, 2019, for the JP Morgan Biotech Showcase. Contact us if you would like to meet up.

MLD to Present Plasmalogen Therapy at Society for Neuroscience

MLD is pleased to announce that their abstract entitled “Development of oral plasmalogen precursors for the treatment of Alzheimer’s disease: Clinical proof-of-concept in the pediatric orphan disease Rhizomelic chondrodysplasia punctata” has been accepted and will be presented at Neuroscience 2018 on Saturday November 3rd. Dr. Tara Smith, Vice President Therapeutics, will be attending the conference and is looking forward to meeting potential partners or collaborators, so if this is an area of interest please come by the poster or contact us here.  

MLD and U of C Secure Metabolomic CRC Screening Grant

University of Calgary and Med-Life Discoveries Secure Grant for Commercialization of Metabolomic Blood Test for Colorectal Cancer.

Saskatoon, Sk. Canada, June 18, 2018: As part of its continued efforts toward the early detection and prevention of colorectal cancer (CRC), Med-Life Discoveries (MLD) is pleased to announce a collaboration with the University of Calgary’s Department of Surgery and Oncology, and the Metabolomics Division in the Department of Biological Sciences, which has successfully been awarded a Collaborative Health Research Project (CHRP; cofounded by CIHR and NSERC) for approximately $750,000. The funds will be used for the commercial development, validation, and potential integration of a multi-analyte metabolomics-based blood test for premalignant colorectal cancer lesions being developed by the University of Calgary, along with the Cologic(TM) Test for colorectal cancer risk, currently manufactured and marketed by MLD.

Dr. Oliver Bathe, Surgical Oncologist and Professor of Surgery and Oncology and the Principle Investigator of the study says: "The goal of the project is the creation of patient-friendly tests that are amenable to population-wide screening. To introduce discoveries made in academic institutions to the clinic, it is critical to have a close relationship with experts who can reduce discoveries to practice. Biomedical companies with expertise in test development, regulatory requirements and commercialization have that experience. For this reason, we expect our collaboration with MLD to be highly productive, bringing to the patient a new way to detect colorectal cancer at a very early stage."

Dr. Shawn Ritchie, MLD’s CEO and inventor of the Cologic(TM) test adds: “MLD’s expertise in commercial mass spectrometry-based metabolomic technology development, including the manufacturing and regulatory nuances that are required to build robust clinical-grade diagnostic assays, is second to none. We see this partnership with Dr. Oliver Bathe, Dr. Hans Vogel, and others at the University of Calgary as a synergistic opportunity to develop and validate the next generation of blood-based screening tests for colorectal and potentially other cancers.” If successful, a multi-analyte test integrating Cologic(TM) for the detection of asymptomatic risk along with the U of C’s panel for the detection of premalignant lesions, would be the first of its kind and set a new standard for the screening and early detection of CRC.

The commercialization plan will be led by Innovate Calgary in collaboration with MLD. Other stakeholders involved in the clinical knowledge translation include the Alberta Surgery and Cancer Strategic Clinical Networks, and Calgary Lab Services.

About MLD
MLD is a biopharmaceutical and diagnostics company dedicated to the early detection and prevention of chronic disease. The company is based out of Saskatoon, SK, Canada and works with collaborators and partners world-wide. MLD’s current products include the Cologic(TM) and PanaSee(TM) blood tests for the detection of CRC and Pancreatic cancer risk, respectively, and preclinical lead therapeutic compounds for the treatment of Rhizomelic Chondrodysplasia Punctata (RCDP), Alzheimer’s disease, Levadopa-induced dyskinesias in Parkinson’s disease, and Multiple Sclerosis.
More information: med-life.ca

BIO USA

Dr. Tara Smith and Seth Yakatan will be in Boston June 4-7, 2018 for Bio USA. Reach us through the Bio partnering portal or contact us here to set up a meeting.

GFPD Conference

Dr. Tara Smith will be attending the Global Foundation for Peroxisomal Disorders Scientific Conference June 1 & 2, 2018, in Washington, DC. The conference brings together leading experts and patient advocates to discuss the latest advancements for the treatment and management of peroxisomal biogenesis disorders, including RCDP.

NEUROTECH

UPDATE! MLD is pleased to announce it has been selected as one of eight companies to present in the Emerging Companies Showcase at NEUROTECH in Boston May 1 and 2, 2018. NEUROTECH showcases the latest trends in emerging drugs, diagnostics, and technologies relating to the brain and nervous system.

MLD presenting at Digestive Diseases Week 2018

Dr. Shawn Ritchie, on behalf of MLD and our collaborators at Rush University, will be presenting at DDW in Washington DC on June 3, 2018. Our presentation highlights recent results connecting GTA fatty acid deficiency, a known risk factor for colorectal cancer, to specific gut microbes. The findings represent the first steps towards a GTA replacement therapeutic strategy for treating colorectal and pancreatic cancer through the modulation of gastrointestinal inflammatory risk.

MLD attending World Orphan Congress

Dr. Shawn Ritchie and Dr. Tara Smith will be on location at the World Orphan Congress, April 25 to 27, 2018, in Oxon Hill, Maryland, in support of our therapeutic development program for the treatment of Rhizomelic Chondrodysplasia Punctata (RCDP).

AGA Tech Summit

MLD is attending the AGA Tech Summit in Boston, March 22 and 23, 2018. This tech forum showcases the latest trends in gastrointestinal innovations, where we will be engaging stakeholders and the GI community about Cologic blood testing for the detection of GTA fatty acids as markers of GI inflammation and colorectal cancer risk.

MLD on location in Amsterdam for Bio Europe

MLD will be on location at BIO Europe in Amsterdam March 12-14, 2018, showcasing our therapeutic pipeline and diagnostic products. Be sure to look us up in the partnering portal or contact us if you would like to meet up.

Abstract detailing plasmalogen replacement therapy accepted for presentation in Torino, Italy, in March 2018.

MLD's Senior Scientist and Team Lead, Therapeutics, Dr. Tara Smith, will be attending the Advances in Alzheimer’s and Parkinson’s Therapies AAT-AD/PD Focus Meeting in Torino, Italy between March 15th  and 18th 2018. On Saturday, March 17th, Tara will present a poster showcasing MLD's latest plasmalogen precursor data for the treatment of Alzheimer's and Parkinson's disease. We would love to meet with any interested partners or collaborators, so be sure to come to the poster or contact us here.

MLD submits Pre-IND package for its RCDP orphan drug

SASKATOON, SK, CANADA. MLD, a developer of advanced plasmalogen-based therapeutic products, is pleased to announce that it has submitted its pre-Investigational New Drug (pre-IND) briefing packet to the FDA for its lead orphan compound, PPI-1040, for the treatment of Rhizomelic Chondrodysplasia Punctata (RCDP). RCDP is a highly debilitating rare paediatric genetic disorder caused by mutations in peroxisomal genes involved in plasmalogen lipid biosynthesis. The FDA has granted MLD a Type B pre-IND meeting scheduled for the last week of January, 2018.

The Pre-IND briefing packet includes information on PPI-1040, preclinical data generated to date, the GLP safety toxicology plan, natural history of the disease, and proposed clinical development path. At the meeting, MLD will be seeking guidance from the FDA on the plan, including suitability of proposed biochemical and functional endpoints.

MLD's Chief Scientific Officer and Interim CEO, Shawn Ritchie, stated, "Preparing this package has been a team effort by MLD, our consultants, and primary investigator. We are very pleased to have an opportunity to visit the FDA in the New Year, and look forward to a constructive meeting. This is a significant milestone in the development of a putative treatment for RCDP, for which there are currently no treatment options."

About MLD

MLD is a Canadian health prevention company developing novel plasmalogen replacement compounds for the treatment of various disorders associated with plasmalogen deficiency, including RCDP, Alzheimer's disease, Parkinson's disease, and Multiple Sclerosis, as well as companion screening tests that detect metabolic risk for chronic diseases including neurodegenerative disorders and cancer.

MLD's Safe Harbor Statement
This document may contain “forward-looking statements” within the meaning of Canadian securities legislation. The words “may”, “will”, “could”, “should”, “would”, “suspect”, “outlook”, “believe”, “plan”, “anticipate”, “estimate”, “expect”, “intend”, “forecast”, “objective”, and “continue” (or the negative thereof), and words and expressions of similar import, are intended to identify forward-looking statements. Forward-looking statements contained in this release are necessarily based on assumptions and information that, while considered reasonable to us, are inherently uncertain. Readers should not place undue reliance on any forward-looking statements. When reviewing our forward-looking statements, investors and others should carefully consider the foregoing factors and other uncertainties and potential events. Except as required by Canadian securities law, we do not undertake to update any forward-looking statements, whether written or oral, that may be made from time to time by us or on our behalf; such statements speak only as of the date made.

Catch up with us in January at JP Morgan

MLD's Chief Scientific Officer and Interim CEO, Shawn Ritchie, along with Seth Yakatan, VP of Business Development and associate Michael d'Amato, will be attending the BIOTECH SHOWCASE at JP Morgan in San Francisco between January 8th and 10th, 2018. We'd love to meet with you, so be sure to look us up in the partnering portal (http://www.partneringone.com/partnering/partnering_home.php) or contact us here.