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News, press, and general updates

2020

Clene Nanomedicine Announces First Patients Enrolled in HEALEY ALS Platform Trial

Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company, is very pleased that the Sean M Healey & AMG Center for ALS at Mass General announced the first patients have been enrolled into the HEALEY ALS Platform Trial being conducted at sites of the Northeast ALS (NEALS) consortium.

Clene Nanomedicine Announces Over 50% of Subjects Randomized in RESCUE-ALS Clinical Trial for Treatment of Amyotrophic Lateral Sclerosis (ALS) with Lead Nanocatalytic Therapeutic, CNM-Au8

Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company, today announced its Australian subsidiary has completed over 50% of participant randomization in the Phase 2 RESCUE-ALS study with its lead nanocatalytic therapy, CNM-Au8, for the treatment of Amyotrophic Lateral Sclerosis (ALS). The RESCUE-ALS study is substantially funded by FightMND.

Clene Nanomedicine Presents Blinded Interim Data from the VISIONARY-MS Phase 2 Study

Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company, today announced interim blinded data from the VISIONARY-MS Phase 2 study demonstrating median improvements in functional scores in the enrolled population of patients with relapsing multiple sclerosis (MS). The interim results will be featured in an oral presentation today at the Joint NAIMS-IMSVISUAL Symposium in conjunction with the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2020, held February 27-29 in West Palm Beach, Florida, as well as during a poster presentation during ACTRIMS.

Clene Nanomedicine Publishes Results Demonstrating Preclinical Efficacy of CNM-Au8 Gold Nanocrystals for Remyelination in Multiple Sclerosis in Scientific Reports

Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company, today announced the publication of original research in Scientific Reports of the Nature Publishing Group in the article, “Nanocatalytic activity of clean-surfaced, faceted nanocrystalline gold enhances remyelination in animal models of multiple sclerosis.” The published data describe the preclinical efficacy of CNM-Au8 to support remyelinating activity, functional myelin generation, and improved motor function in animal models of Multiple Sclerosis (MS).

2019

Clene Nanomedicine Presents New Neuroprotection Data in Parkinson’s Disease with Lead Nanocatalytic Therapeutic, CNM-Au8

Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company, today announced the presentation of new preclinical neuroprotection data in multiple Parkinson’s disease models at the 2019 Society for Neuroscience (SfN) Annual Meeting.

Clene Nanomedicine Awarded Research Grant from the National Multiple Sclerosis Society to Support Clinical Development of its Lead Nanocatalytic Therapeutic, CNM-Au8

Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company, today announced that the National Multiple Sclerosis Society (NMSS) has awarded the company a research grant totaling more than $339,000 to support the clinical development of its nanocatalytic therapeutic, CNM-Au8, for the treatment of multiple sclerosis (MS).

Clene Nanomedicine, Inc. Announces Selection of CNM-Au8 for the Harvard Led HEALEY ALS Platform Trial, a Clinical Trial for Amyotrophic Lateral Sclerosis 

Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company, announced today that the Sean M. Healey & AMG Center for ALS at Mass General has selected CNM-Au8 for inclusion in the first ever Platform Trial for the treatment of amyotrophic lateral sclerosis (ALS). 

 

 

Clene Nanomedicine, Inc. Awarded $1.37M AUD Grant from FightMND to Conduct Phase 2 Clinical Study for the Treatment of Amyotrophic Lateral Sclerosis

Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company, announced today its Australian subsidiary has been awarded a $1.37 M AUD grant from the FightMND (Fight Motor Neuron Disease) foundation of Australia. The grant will substantially fund a clinical trial to assess the efficacy and safety of Clene’s novel nanocatalyst, CNM-Au8, to slow disease progression in patients with amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s Disease. 

 

Clene Nanomedicine, Inc. Announces FDA Grant of Orphan Drug Designation for CNM-Au8 for the Treatment of Amyotrophic Lateral Sclerosis

Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company developing a new class of orally-administered neurotherapeutic drugs using a novel drug development platform, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to CNM-Au8, the Company’s therapeutic nanocatalyst for the treatment of amyotrophic lateral sclerosis (ALS). 

 

Clene Nanomedicine Announces Preclinical Data Demonstrating a Novel Gold Nanocrystal as a Remyelinating Treatment for Multiple Sclerosis at ACTRIMS Forum Annual Meeting

  • Late breaking abstract presented in the ‘Cutting Edge Developments in MS Research Session’ at the third annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum, held Feb 1-3, in San Diego, California 
  • Clene’s Phase II VISIONARY-MS trial set to begin in the second half of 2018

 

Clene Nanomedicine Announces First Patient Dosed in the RESCUE-ALS Clinical Trial for the Treatment of Amyotrophic Lateral Sclerosis (ALS) with Lead Nanocatalytic Therapeutic, CNM-Au8

Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company, today announced its Australian subsidiary had completed enrollment and dosing of the first participant in the Phase 2 RESCUE-ALS study with its lead nanocatalytic therapy, CNM-Au8, for the treatment of Amyotrophic Lateral Sclerosis (ALS). The RESCUE-ALS study is substantially funded by FightMND.

2018

Clene Nanomedicine to Present Data at the 34th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS 2018) Demonstrating Activation of Myelination Gene Transcription in Oligodendrocytes by a Gold Nanocrystal Therapeutic, CNM-Au8

A poster presentation will describe bioenergetic enhancement of remyelination in oligodendrocytes by Clene Nanomedicine’s lead clean-surfaced, faceted gold nanocrystal asset, CNM-Au8, as a potential new treatment for multiple sclerosis at ECTRIMS in Berlin, Oct 10-12, 2018. Clene’s Phase II VISIONARY-MS trial of CNM-Au8 for the treatment of chronic optic neuropathy associated with relapsing remitting multiple sclerosis commences this month.

Clene Nanomedicine Presents Talks in Boston at the 256th ACS National Meeting Demonstrating Superior Biological Catalytic Activity and Low Toxicity of Gold Nanocrystals Prepared Using a Novel Electrochemical Method

Two invited oral presentations by Clene scientists will describe the chemical properties, IND-enabling toxicology, and Phase I human trial results of Clene Nano medicine’s lead gold nanocrystal asset, CNM-Au8, at the National ACS Meeting in Boston, August 19-23. Clene’s Phase II VISIONARY-MS trial of CNM-Au8 for the treatment of chronic optic neuropathy associated with relapsing remitting multiple sclerosis set to begin in Q3 2018.

Clene Nanomedicine Presents Talks in Boston at the 256th ACS National Meeting
Demonstrating Superior Biological Catalytic Activity and Low Toxicity of Gold Nanocrystals
Prepared Using a Novel Electrochemical Method

Two invited oral presentations by Clene scientists will describe the chemical properties, IND-enabling toxicology, and Phase I human trial results of Clene Nanomedicine’s lead gold nanocrystal asset, CNM-Au8, at the National ACS Meeting in Boston, August 19-23.

Clene’s Phase II VISIONARY-MS trial of CNM-Au8 for the treatment of chronic optic neuropathy associated with relapsing remitting multiple sclerosis set to begin in Q3 2018.

CLENE PRESENTS PRECLINICAL REMYELINATION RESULTS AT ANNUAL ACTRIMS MEETING IN SAN DIEGO.

Clene Nanomedicine, Inc. (Clene), a privately held biopharmaceutical company using proprietary platform technology to develop clean-surface nanotherapeutic medicines, today presented preclinical remyelination data at a ‘Late-Breaking Research’ platform presentation session at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS). https://www.medscape.com/viewarticle/892250. Clene anticipates initiating a Phase 2 study (VISIONARY-MS) in Q2 2018 in patients with chronic optic neuropathy caused by Relapsing Remitting Multiple Sclerosis (RRMS).

2017

CLENE ANNOUNCES SUCCESSFUL COMPLETION OF PHASE I STUDY IN HEALTHY HUMAN VOLUNTEERS.

Clene Nanomedicine, Inc. (Clene), a privately held biopharmaceutical company using proprietary platform technology to develop clean-surface nanocrystal medicines, today announced completion of its Phase 1 program in healthy volunteers with CNM-Au8. Single and Multiple Ascending Dose phases of the study were completed with no significant adverse effects attributable to CNM-Au8. Clene anticipates initiating a Phase 2 study (VISIONARY-MS) in Q2 2018 in patients with chronic optic neuropathy caused by Relapsing Remitting Multiple Sclerosis (RRMS).

2016

CLOSE OF SERIES B CAPITAL RAISE.

Clene Nanomedicine, Inc. (Clene), a privately held biopharmaceutical company using proprietary platform technology to develop clean-surface nanotherapeutic medicines, today announced the close of its oversubscribed Series B Financing Round at an aggregate amount of $17M USD. The capital raise will be used to fund continuing operations, the Phase I clinical program for Clene’s lead asset, CNM-Au8, and further preclinical studies to more fully elucidate the mechanism(s) of action of CNM-Au8 in the treatment of demyelinating disorders such as neuromyelitis optica and/or multiple sclerosis, as well as early development of another Clene nanotherapeutic drug asset.

CLENE INITIATES MULTIPLE ASCENDING DOSE PROTOCOL IN ITS PHASE 1 STUDY IN HEALTHY HUMAN VOLUNTEERS

Clene Nanomedicine, Inc. (Clene), a privately held biopharmaceutical company using proprietary platform technology to develop clean-surface nanocrystal therapeutics, today announced the initiation of the Phase 1b Multiple Ascending Dose clinical program for its lead asset, CNM-Au8, in healthy human volunteer subjects at the clinical research organization Centre for Human Drug Research (CHDR) in Leiden, Netherlands. In the Multiple Ascending Dose protocol, which is a blinded, randomized, placebo-controlled trial, four doses (15, 30, 60, and 90 mg as an oral suspension) of CNM-Au8 will be clinically evaluated. Each dosing cohort will undergo a mandatory safety review before progression to the next higher dosing cohort. Each subject will be treated daily for 21 consecutive days, with periodic blood collection for pharmacokinetic profiling of CNM-Au8. Clene anticipates completion of the Phase 1b Multiple Ascending Dose protocol in late 2016.

EU PATENT VALIDATED FOR NOVEL BI-METALLIC PLATINUM-GOLD NANOCRYSTAL.

Clene Nanomedicine, Inc. (Clene), a privately held biopharmaceutical company using proprietary platform technology to develop clean-surface nanocrystal therapeutics, today announced it had received validation of its novel bi-metallic platinum-gold nanocrystal patent filing with the European Patent Office for the countries of Denmark, Finland, France, Germany, Ireland, Italy, Netherlands, Norway, Spain, Sweden, Switzerland, Liechtenstein, and the United Kingdom. The granted claims are for the novel suspensions, methods for making the novel suspensions and therapeutic uses of the same. Clene has also recently received notification of a U.S. patent grant for manufacturing and therapeutic uses of a novel silver-zinc liquid composition. These latest patent approvals add to Clene’s patent portfolio for the novel nanocrystalline suspensions, manufacturing methods, and therapeutic applications of metallic nanocrystalline drug suspensions.

CLENE ANNOUNCES COMPLETION OF THE SINGLE ASCENDING DOSE PORTION OF PHASE I PROTOCOL IN HEALTHY HUMAN VOLUNTEERS.

Clene Nanomedicine, Inc. (Clene), a privately held biopharmaceutical company using proprietary platform technology to develop clean-surface nanocrystal medicines, today announced completion of the first Single Ascending Dose portion of its Phase 1 program in healthy volunteers. The Phase 1 Single Ascending Dose portion concluded in December 2015 with no significant adverse effects attributable to CNM-Au8. The second part of the Phase 1 study, the Multiple Ascending Dose protocol, will commence in April 2016.

2015

CLENE SIGNS COLLABORATIVE RESEARCH AGREEMENT WITH OHSU.

Clene Nanomedicine, Inc. (Clene), a privately held biopharmaceutical company using proprietary platform technology to develop clean-surface nanocrystal therapeutics, today announced the signature of a collaborative research agreement with OHSU in Portland, Oregon. Under the guidance of Drs. Susan Hayflick, M.D., and Suh Young Jeong, Ph.D., OHSU will complete a series of preclinical experiments, which will explore mitochondrial protection and the mechanism and effects of CNM-Au8 on models of mitochondrial function and its potential application to neurodegenerative diseases.

CLENE SIGNS COLLABORATIVE RESEARCH AGREEMENT WITH NORTHWESTERN UNIVERSITY.

Clene Nanomedicine, Inc. (Clene), a privately held biopharmaceutical company using proprietary platform technology to develop clean-surface nanocrystal therapeutics, today announced the signature of a collaborative research agreement with Northwestern University. Under the guidance of Dr. Stephen Miller, Northwestern will complete a series of preclinical experiments exploring the mechanism and effects of CNM-Au8 on oliogodendrocyte biology in myelination and demyelination models. Clene expects the data from these experiments will further understanding regarding how CNM-Au8 affects foundational cellular processes in support of myelination and may identify optimal clinical indications for treatment of demyelinating diseases for Clene’s Phase 2 clinical program.

FDA Approval to Commence Phase I Single Ascending Dose Protocol.

Clene Nanomedicine, Inc. (Clene), a privately held biopharmaceutical company using proprietary platform technology to develop clean-surface nanotherapeutic medicines, today announced the United States Food and Drug Administration has granted approval for Clene to proceed with its Phase 1a Single Ascending Dose clinical protocol of CNM-Au8 in healthy human volunteer subjects in the United States.

Initiation of Phase I Clinical Program.

Clene Nanomedicine, Inc. (Clene), a privately held biopharmaceutical company using proprietary platform technology to develop clean-surface nanotherapeutic medicines, today announced the initiation of its Phase Ia Single Ascending Dose clinical program in healthy human volunteer subjects at the clinical research organization Centre for Human Drug Research (CHDR) in Leiden, Netherlands. In the Single Ascending Dose protocol, four doses of CNM-Au8 are administered in conjunction with blinded, randomized placebo. Each dosing cohort will undergo a mandatory safety review before progression to the next higher dosing cohort. Each subject will be followed for seventeen days post-dosing for safety review and blood collection for pharmacokinetic profiling of CNM-Au8. Following safety and PK analyses of the Phase 1a results, Clene anticipates continuation to a Phase Ib Multiple Ascending Dose protocol in early 2016.

Close of Series A Capital Raise.

Clene Nanomedicine, Inc. (Clene), a privately held biopharmaceutical company using proprietary platform technology to develop clean-surface nanotherapeutic medicines, today announced the close of its oversubscribed Series A Financing Round at an aggregate amount of $31.6M USD. Notably, it is Clene’s understanding this may be one of the largest non- institutional, Angel-financed raises in biopharmaceutical history. Clene is pleased by the trust and commitment of its investor group. The capital raise will be used to fund continuing operations, the Phase I clinical program for Clene’s lead asset, CNM-Au8, and further preclinical studies to more fully elucidate the mechanism(s) of action of CNM-Au8 in the treatment of demyelinating disorders such as neuromyelitis optica and/or multiple sclerosis, as well as early development of another Clene nanotherapeutic drug asset.

Clene Receives IMPD Approval; Phase I Clinical Program Planned.

Clene Nanomedicine, Inc. (Clene), a privately held biopharmaceutical company using proprietary platform technology to develop clean-surface nanotherapeutic medicines, today announced the approval by the Netherlands’ Competent Authority for the initiation of the Phase I study in healthy human volunteer subjects for Clene’s lead asset, CNM-Au8. Clene has chosen the Centre for Human Drug Research (CHDR), a globally reputable clinical research organization located near the University of Leiden for the execution of this Phase I study. Clene plans to initiate the Phase I program later this year.

Clene Appoints Head Head of Strategic Operations.

Clene Nanomedicine, Inc. (Clene), a privately held biopharmaceutical company using proprietary platform technology to develop clean-surface nanotherapeutic medicines, today announced the appointment of Michael Hotchkin as Head, Strategic Operations. Michael Hotchkin has over fifteen years in the biopharmaceutical industry with diverse experiences including roles in commercial and medical affairs. Most recently, Michael led a boutique strategic consulting firm, AvantureBio LLC supporting biopharmaceutical clients. Prior to that he led Actelion Pharmaceuticals Genetics business unit with primary commercial responsibility for sales and marketing. Michael’s extensive experiences in strategic planning, business development, medical affairs, and operational planning will assist Clene’s planning activities and fundraising.

Clene Files Investigational Medicinal Product Dossier For Research in the EU.

Clene Nanomedicine, Inc. (Clene), a privately held biopharmaceutical company using proprietary platform technology to develop clean-surface nanotherapeutic medicines, today announced it had filed an Investigational Medicinal Product Dossier (IMPD) for clinical research in the Netherlands. All essential regulatory documents have been prepared and submitted to both the Netherlands’ Competent Authority and the responsible Ethics Committee.

2014

Clene Announces FDA Clinical Hold Placed on IND Application.

Clene Nanomedicine, Inc. (Clene), a privately held biopharmaceutical company using proprietary platform technology to develop clean-surface nanotherapeutic medicines, today announced it had received a Full Clinical Hold in response to its IND submission on August 27, 2014. Due to the absence of identified toxicities at the highest doses tested in animals to date, the FDA has requested additional preclinical studies in animals to establish a maximum tolerated dose, maximum feasible dose, or to meet another criterion for an acceptable high dose. Clene anticipates fulfilling the FDA request by the second half of 2015.

Clene Files Investigational New Drug Application With FDA.

Clene Nanomedicine, Inc. (Clene), a privately held biopharmaceutical company using proprietary platform technology to develop clean-surface nanotherapeutic medicines, today announced it has submitted an Investigational New Drug (IND) application with the Food and Drug Administation in the United States for its lead asset, CNM-Au8, a liquid nanosuspension consisting of clean surface elemental gold nanocrystals in buffered deionized water. The gold nanocrystal suspension is developed through a proprietary process utilizing electrochemistry and plasma physics to produce self-assembled, atomically clean-surface elemental gold nanocrystals unmodified by the addition of surfactants or surface capping agents. FDA approval of the IND will permit Clene to commence Phase I pharmacokinetic and safety studies in healthy human volunteers.

Clene Announces Incorporation.

Clene Nanomedicine, Inc. (Clene), a privately held biopharmaceutical company using proprietary platform technology to develop clean-surface nanotherapeutic medicines, today announced it had completed conversion from a Limited Liability Corporation (LLC) to a C-corp incorporated in the state of Delaware.

Pre-IND Meeting Request.

Clene Nanomedicine, LLC (Clene), a privately held biopharmaceutical company using proprietary platform technology to develop clean-surface nanotherapeutic medicines, today announced it has formally requested a Pre-IND (Investigational New Drug application) meeting with the FDA to review its plan to enter clinical trials. This Pre-IND meeting is one of the final steps prior to filing an IND to begin clinical trials and will be an opportunity to preview with the Agency its information package and clinical trial plan for Clene’s lead drug, CNM-Au8. This will clarify and allow us to resolve any remaining issues or questions. Starting clinical trials is the next key milestone in the evolution of Clene, and has important implications for the development and funding of the Company. Unlike companies in almost all other industries, most new pharmaceutical companies go public during the product development stage well before revenues, and prior to drug approval. Of the thirty-five biotech IPO’s launched through November of 2013, 85% were in clinical development stage with no commercialized drugs. In fact, the majority of 2013 biotechnology IPOs were in early to mid-stage clinical trials in Phase I or Phase II. Clene is keenly focused on completing nonclinical trials preparatory for the FDA submission package for its lead drug CNM-Au8, to propose a Phase I clinical trial, with a target of being in Phase II clinical trials closely following the completion of the Phase I program. This would continue to strengthen Clene’s pioneering nanomedicine platform technology and could begin to position Clene as a potentially attractive IPO candidate.