Investigational therapy AD-214 raised no safety concerns in preliminary studies in non-human primates, and AdAlta, the therapys developer, is now planning to launch a Phase 1 clinical trial in humans, the company announced.
AD-214 is amodification of AdAltas original lead candidate for the treatment of pulmonary fibrosis (PF), AD-114. AD-214 contains two i-bodies modified antibodies that specifically target the protein CXCR4. The therapy is primarily being developed for idiopathic pulmonary fibrosis (IPF) and other fibrotic diseases.
Researchers at AdAlta have now completed three studies in non-human primates. One study tested a single dose of AD-214, while the two others tested multiple doses over the course of a month tested doses were 10, 30, and 100 mg/kg. The goal of these studies was to evaluate the safety of the compound and its pharmacology (the therapys effects and properties).
Results from these studies showed that AD-214 was safe and well-tolerated, with no deaths or adverse events reported. No signs of overt toxicity were seen when AD-214 was given intravenously (into the vein) at the highest dose (100 mg/kg). In addition, researchers saw no changes in body weight, nor in respiratory, cardiovascular, neurological, and ophthalmology tests.
There were, however, some reported increases in white blood cell counts immediately after treatment, but they returned to normal within a day. There were also decreases in the levels of certain blood proteins, such as albumin, which were described as slight and completely reversible.
Based on these results, the company is planning to advance the development ofAD-214 into Phase 1 trials in humans within the first few months of 2020.
Bulk manufacturing of AD-214 for Phase 1 trials was completed and done under Good Manufacturing Practice (GMP) conditions, a requirement for regulatory submissions to the U.S. Food and Drug Administration and other agencies.
We are pleased to reach both the toxicology and GMP drug substance manufacturing milestones on schedule and with expected results, enabling us to progress AD-214 into safety studies in humans as an important next step in bringing a much-needed new therapeutic option to fibrosis patients, and in demonstrating the safety of the i-body as a platform, Tim Oldham, managing director and CEO of AdAlta, said in a press release.
We also look forward to additional pharmacokinetic and pharmacodynamic information from this study in the near future, he added.
Marisa holds an MS in Cellular and Molecular Pathology from the University of Pittsburgh, where she studied novel genetic drivers of ovarian cancer. She specializes in cancer biology, immunology, and genetics. Marisa began working with BioNews in 2018, and has written about science and health for SelfHacked and the Genetics Society of America. She also writes/composes musicals and coaches the University of Pittsburgh fencing club.
Total Posts: 110
Patrcia holds her PhD in Medical Microbiology and Infectious Diseases from the Leiden University Medical Center in Leiden, The Netherlands. She has studied Applied Biology at Universidade do Minho and was a postdoctoral research fellow at Instituto de Medicina Molecular in Lisbon, Portugal. Her work has been focused on molecular genetic traits of infectious agents such as viruses and parasites.
Read the original post:
Potential PF Therapy AD-214 to Move into Phase 1 Testing in Humans - Pulmonary Fibrosis News
- Cardiology and Cardiac Pharmacology - April 4th, 2018 [April 4th, 2018]
- EMS Pharmacology: Drugs That Affect the Cardiovascular System ... - April 8th, 2018 [April 8th, 2018]
- EMS Pharmacology: Drugs That Affect the Cardiovascular ... - April 11th, 2018 [April 11th, 2018]
- Cardiology Conferences - Cardiology and Cardiovascular ... - June 5th, 2018 [June 5th, 2018]
- Cardiovascular Pharmacology: Open Access - Open Access ... - June 21st, 2018 [June 21st, 2018]
- CV Pharmacology | Welcome to Cardiovascular Pharmacology ... - July 31st, 2018 [July 31st, 2018]
- Cardiology Conferences | Cardiac pharmacology 2018 ... - September 13th, 2018 [September 13th, 2018]
- Cardiology Conference | Cardiac Pharmacology 2019 ... - November 18th, 2018 [November 18th, 2018]
- Cardiovascular Pharmacology Online Course | Lecturio - November 30th, 2018 [November 30th, 2018]
- Cardiovascular Pharmacology: Open Access - December 16th, 2018 [December 16th, 2018]
- Cardiovascular In vivo Models for Drug Discovery - December 21st, 2018 [December 21st, 2018]
- UTHSC College of Medicine: Department of Pharmacology - February 2nd, 2019 [February 2nd, 2019]
- Department of Pharmacology - School of Medicine - LSU ... - April 5th, 2019 [April 5th, 2019]
- Cardiovascular Pharmacology: Open Access - longdom.org - April 22nd, 2019 [April 22nd, 2019]
- ASPET | Cardiovascular Pharmacology - September 14th, 2019 [September 14th, 2019]
- Pharmacogenomics Market (PGx) Competitive Research And Precise Outlook 2019 To 2025: Astrazeneca, GeneDX, Illumina, Inc., Laboratory Corporation of... - September 18th, 2019 [September 18th, 2019]
- Global and Chinese Microbiome Drugs Market: Industry strategic plan for the period 2019-2024 - Market Report Gazette - September 18th, 2019 [September 18th, 2019]
- Pharmacokinetics Market To Increase at Steady Growth Rate - Commerce Gazette - September 18th, 2019 [September 18th, 2019]
- Moderna Announces Positive Phase 1 Results for the First Systemic Messenger RNA Therapeutic Encoding a Secreted Protein (mRNA-1944) - BioSpace - September 18th, 2019 [September 18th, 2019]
- Janssen to Highlight Depth of Prostate Cancer and Solid Tumor Portfolios with Multiple Data Presentations at ESMO 2019 - Yahoo Finance - September 18th, 2019 [September 18th, 2019]
- Cardiac fibrosis study identifies key proteins that translate into heart disease - BSA bureau - September 18th, 2019 [September 18th, 2019]
- Nitric Oxide: Worldwide Therapeutics & Markets to 2028 with Profiles on 35 Companies & 18 Collaborations Tabulated - Yahoo Finance - September 18th, 2019 [September 18th, 2019]
- Cytokinetics Announces Data From Phase 1 Study of CK-3773274 at the HFSA 23 Annual Scientific Meeting - Yahoo Finance - September 18th, 2019 [September 18th, 2019]
- Is it risky to continue with blood thinner drugs after a gastrointestinal bleed? - Medical News Bulletin - September 18th, 2019 [September 18th, 2019]
- Women urged to exercise and eat well due to cholesterol after menopause - Sydney Morning Herald - September 18th, 2019 [September 18th, 2019]
- Former Executive Director of Preclinical Safety at Novartis, Klaus Peter Hoffmann, MD, PhD, Joins NDA Partners as Expert - Yahoo Finance - September 18th, 2019 [September 18th, 2019]
- Yale alumna Dr. Nancy Brown named dean of Yale School of Medicine - Yale News - September 18th, 2019 [September 18th, 2019]
- Verve Therapeutics Appoints Cardiologist Andrew Bellinger, M.D., Ph.D., as Chief Scientific Officer - Business Wire - October 7th, 2019 [October 7th, 2019]
- G-Protein Coupled Receptors (GPCRs) Market Size And Prediction By Leading Manufacturers According To Its Application And Types Till 2022 - Space... - October 7th, 2019 [October 7th, 2019]
- Best supplements for blood pressure: The natural remedy proven to lower your reading - Express - October 7th, 2019 [October 7th, 2019]
- Advanced Drug Delivery Systems Market Growth Analysis 2019 to Share Key Aspects of the Industry with the details of Influence Factors Forecast to 2024... - October 28th, 2019 [October 28th, 2019]
- The 9 Biggest Technology Trends That Will Transform Medicine And Healthcare In 2020 - Forbes - November 6th, 2019 [November 6th, 2019]
- Edited Transcript of CYTK earnings conference call or presentation 31-Oct-19 8:30pm GMT - Yahoo Finance - November 6th, 2019 [November 6th, 2019]
- The Montreal Heart Institute celebrates its 500th heart transplant - GlobeNewswire - November 6th, 2019 [November 6th, 2019]
- Latest Research Report to uncover key Factors of Global Cardiovascular Repair And Reconstruction Devices Market - Market Research Base - November 6th, 2019 [November 6th, 2019]
- Global Cardiovascular Repair And Reconstruction Devices Market: Development History, Current Analysis and Estimated Forecast to 2025 - Market Research... - November 29th, 2019 [November 29th, 2019]
- The cardiac safety services market is projected to reach USD 752 million by 2024 from USD 442 million in 2019, at a CAGR of 11.2% - Yahoo Finance - December 11th, 2019 [December 11th, 2019]
- Evaluation of the Effect of Fish Oil Alone and in Combination with a P | DMSO - Dove Medical Press - January 13th, 2020 [January 13th, 2020]
- Amarin's Multiple Positives And Other News: The Good, Bad, And Ugly Of Biopharma - Seeking Alpha - January 25th, 2020 [January 25th, 2020]
- Heres What We Know About CBDs Effects On Varicose Veins - The Fresh Toast - January 28th, 2020 [January 28th, 2020]
- Hypertension: This Spice Can Help You Control High Blood Pressure Easily And Effectively - Doctor NDTV - January 28th, 2020 [January 28th, 2020]
- Cannabis Manual: Better Together - Weekly Alibi - January 30th, 2020 [January 30th, 2020]
- Pharmacology: Cardiovascular Drugs 1 (30 Items) - Nurseslabs - March 1st, 2020 [March 1st, 2020]
- A central master driver of psychosocial stress responses in the rat - Science Magazine - March 9th, 2020 [March 9th, 2020]
- The Global Cardiac Safety Services Market is expected to grow from USD 419.45 Million in 2018 to USD 865.23 Million by the end of 2025 at a Compound... - March 29th, 2020 [March 29th, 2020]
- Milestone Pharmaceuticals Announces Topline Results from First-of-its-kind Phase 3 NODE-301 Trial of Etripamil for At-home Acute PSVT Treatment -... - March 29th, 2020 [March 29th, 2020]
- Fresh Produce In Short Supply? Prioritize This Veggie In Your Diet - mindbodygreen.com - April 25th, 2020 [April 25th, 2020]
- COVID-19: What's RNA research got to do with it? - University of Rochester - May 1st, 2020 [May 1st, 2020]
- What Happens When You Add Other Drugs To Your LSD Trip? - VICE - May 1st, 2020 [May 1st, 2020]
- Toward a Pharmacology of Resolution - Harvard Magazine - May 1st, 2020 [May 1st, 2020]
- GLYCOMIMETICS : MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS (form 10-Q) - marketscreener.com - May 2nd, 2020 [May 2nd, 2020]
- This Simple Breathing Advice From A Nobel Prize Winner Can Turn The Tables On Stress During The Coronavirus Lockdown - Forbes - May 2nd, 2020 [May 2nd, 2020]
- National Nurses Week 2020: What Experiences Have Shaped Your Nursing Career? - HealthLeaders Media - May 2nd, 2020 [May 2nd, 2020]
- Research Paper Stresses Importance of Repurposing Drugs Against COVID-19 - BioSpace - May 13th, 2020 [May 13th, 2020]
- Repurposing existing drugs to treat coronavirus will likely be quicker than a vaccine, scientists claim - CNBC - May 13th, 2020 [May 13th, 2020]
- Alzheimer's and Cannabis - Greenway - Greenway - May 18th, 2020 [May 18th, 2020]
- Moderna Highlights Advances in Platform Science and Innovative Vaccine Research at Third Annual Science Day - Business Wire - June 2nd, 2020 [June 2nd, 2020]
- Healthy people shouldn't take daily aspirin to prevent heart disease, review finds - WDJT - June 6th, 2020 [June 6th, 2020]
- Study reveals how living close to roadways may impact the brain - Drew Reports News - June 18th, 2020 [June 18th, 2020]
- Disruptions in circadian rhythms not only cause sleep disorders, but could also put you at risk of these... - Firstpost - June 18th, 2020 [June 18th, 2020]
- NeonMind Files Patent Application for Therapeutic Use of DMT - Yahoo Finance - June 18th, 2020 [June 18th, 2020]
- Vitamin D What you need to know about the sunshine vitamin - Medical News Bulletin - July 9th, 2020 [July 9th, 2020]
- Idorsia announces positive results in the second Phase 3 study of daridorexant - GlobeNewswire - July 9th, 2020 [July 9th, 2020]
- ATAI Life Sciences takes on opioid crisis by acquiring Kures to develop novel therapeutics for opioid abuse - PRNewswire - July 9th, 2020 [July 9th, 2020]
- Drug Discovery Outsourcing Market Highly Favorable with new Demand to the Growth Rate by 2027| Thermo Fisher Scientific, Merck KGaA, Albany Molecular... - August 21st, 2020 [August 21st, 2020]
- Bringing Peer Review To Early COVID-19 Research, More News - Bio-IT World - August 21st, 2020 [August 21st, 2020]
- Cardiac Safety Services Market Research Report by Type of Service, by Type, by End User - Global Forecast to 2025 - Cumulative Impact of COVID-19 -... - August 21st, 2020 [August 21st, 2020]
- UCI study finds women with diabetes and high levels of coronary artery calcium at greater risk of death than men - Newswise - August 21st, 2020 [August 21st, 2020]
- Globa Advanced Drug Delivery Systems Market 2020 Research, Key Players, Industry Overview, Supply and Consumption Analysis 2024 - Bulletin Line - September 2nd, 2020 [September 2nd, 2020]
- Esperion Announces Two Data Presentations of NEXLETOL (bempedoic acid) Tablet at the ESC Congress 2020 - GlobeNewswire - September 2nd, 2020 [September 2nd, 2020]
- Women with diabetes and high levels of coronary artery calcium at greater risk of death than men - UCI News - September 2nd, 2020 [September 2nd, 2020]
- 15 Clever Ways to Use Leftover Red Wine - Yahoo Lifestyle - September 2nd, 2020 [September 2nd, 2020]
- UK Study Leads to Better Understanding of Blood Pressure Regulation, Atherosclerosis - UKNow - September 2nd, 2020 [September 2nd, 2020]
- Academic always top of the class for pay and conditions - Extra.ie - September 15th, 2020 [September 15th, 2020]
- Cardiac Safety Services Market Size Is Rising Tremendously Due To Increasing Need of Healthcare Services Centralization Till 2025 - TC BizNews - September 15th, 2020 [September 15th, 2020]
- 5 Benefits of Berberine, Including Why It's a Healthy Gut All-Star - msnNOW - September 15th, 2020 [September 15th, 2020]
- Advanced Drug Delivery Systems Market 2020 Report Covers Key Growth Factors, Global Trends, Opportunities by Regions, Industry Size and Share... - September 23rd, 2020 [September 23rd, 2020]
- Janssen Presents Findings from Global, Multi-Center Trial Examining Amivantamab in Combination with Lazertinib in Patients with EGFR-Mutated Non-Small... - September 23rd, 2020 [September 23rd, 2020]
- MASSIVE GROWTH OF DRUG DISCOVERY SERVICES MARKET WILL RAISE USD 19.1 BILLION BY 2027, CAGR +13% FROM 2020 TO 2027 WITH TOP KEY PLAYERS LIKE THERMO... - September 29th, 2020 [September 29th, 2020]
- The global mice model market size is projected to reach USD 1.9 billion by 2025 from USD 1.4 billion in 2020, at a CAGR of 6.4% - Stockhouse - September 29th, 2020 [September 29th, 2020]