Tafenoquine

Enrollment in 60 Degrees Pharmaceuticals Clinical Trial of Tafenoquine for Babesiosis to Begin at Tufts Medical Center; First Study of Its Kind

Retrieved on: 
목요일, 5월 30, 2024
Patient, Infection, Literature, Babesiosis, Food, Clinical trial, Malaria, Safety, Tafenoquine, Incidence, Lyme disease, Tufts Medical Center

Recruitment of at least 24 hospitalized patients diagnosed with babesiosis will begin after a site initiation visit at Tufts Medical Center on June 13, 2024.

Key Points: 
  • Recruitment of at least 24 hospitalized patients diagnosed with babesiosis will begin after a site initiation visit at Tufts Medical Center on June 13, 2024.
  • Babesiosis is a steadily emerging, infectious disease transmitted by a microscopic parasite, Babesia, through the bite of the black-legged (deer) tick, the vector that spreads Lyme disease.
  • “The literature suggests tafenoquine may be a promising alternative for the treatment of patients hospitalized with relapsing babesiosis, so we are pleased to partner with Tufts Medical Center to conduct the first clinical trial of tafenoquine in treating hospitalized babesiosis patients.
  • 60 Degrees Pharmaceuticals is in negotiations with other leading university hospitals in the Northeast U.S. to add two other clinical trial sites.

60 Degrees Pharmaceuticals Outlines Upcoming Clinical Trial of Tafenoquine in Babesiosis in Letter to Journal of Infectious Diseases

Retrieved on: 
수요일, 5월 8, 2024
Infection, FDA, Efficacy, Safety, Patient, Babesiosis, Pharma, Food, Malaria, Doctor of Philosophy, Tafenoquine, Notifiable disease, Clinical trial, Letter, Journal, Pharmaceutical industry

The upcoming 60 Degrees Pharma clinical trial of tafenoquine in treating babesiosis will be the first and only such study to date.

Key Points: 
  • The upcoming 60 Degrees Pharma clinical trial of tafenoquine in treating babesiosis will be the first and only such study to date.
  • The Journal of Infectious Diseases has published a letter outlining the planned trial protocol.
  • Dr. Dow’s response to those comments outlines plans by 60 Degrees Pharmaceuticals to launch a clinical trial to study the use of tafenoquine in treating human babesiosis.
  • Babesiosis, a potentially life-threatening disease in immunosuppressed patients, is a tick-borne illness steadily emerging in the United States.

60 Degrees Pharmaceuticals to Sponsor Pilot Study of Tafenoquine for Treatment of Canine Babesiosis

Retrieved on: 
수요일, 4월 3, 2024
Tafenoquine, Food and Drug Administration, Infection, Food, FDA, Babesiosis, Dog, Malaria

WASHINGTON, April 03, 2024 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP ; SXTPW) (or the “Company”), a pharmaceutical company focused on developing new medicines for infectious diseases, announced today that the Company will sponsor a pilot study of tafenoquine, the active molecule in its U.S. Food and Drug Administration (FDA)-approved human malaria prevention medication, ARAKODA®, for the treatment of babesiosis in dogs.

Key Points: 
  • WASHINGTON, April 03, 2024 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP ; SXTPW) (or the “Company”), a pharmaceutical company focused on developing new medicines for infectious diseases, announced today that the Company will sponsor a pilot study of tafenoquine, the active molecule in its U.S. Food and Drug Administration (FDA)-approved human malaria prevention medication, ARAKODA®, for the treatment of babesiosis in dogs.
  • The study will support a broader effort now being led by 60 Degrees Pharmaceuticals to evaluate tafenoquine for various babesiosis indications.
  • Tafenoquine has not been proven to be effective for treatment or prevention of canine babesiosis and is not approved by the FDA for such an indication.

60 Degrees Pharmaceuticals Announces Communication from the FDA of Intention to Respond to Tafenoquine-Babesiosis Trial Protocol Submission in April, 2024

Retrieved on: 
목요일, 3월 14, 2024
Drug discovery, Tafenoquine, Patient, Ageing, Degree, Infection, Investigational New Drug, Malaria, FDA, Food, Pharmaceutical industry

WASHINGTON, March 14, 2024 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. , (NASDAQ: SXTP , SXTPW) (“60 Degrees Pharmaceuticals” or the “Company”), a pharmaceutical company focused on developing new medicines for infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has communicated its intention to send any comments regarding the Company’s babesiosis trial within the month of April, 2024, rather than March, 2024 as anticipated by the Company.

Key Points: 
  • WASHINGTON, March 14, 2024 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. , (NASDAQ: SXTP , SXTPW) (“60 Degrees Pharmaceuticals” or the “Company”), a pharmaceutical company focused on developing new medicines for infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has communicated its intention to send any comments regarding the Company’s babesiosis trial within the month of April, 2024, rather than March, 2024 as anticipated by the Company.
  • The protocol submission mechanism as directed by the FDA, i.e., under the Company’s existing (rather than a new) Investigational New Drug application, technically does not require a response from the FDA within a specified time frame.
  • The Company is continuing preparations for a June 1, 2024 start date as previously communicated.
  • Tafenoquine is the active ingredient in an anti-malarial approved by the FDA in 2018 and is indicated for the prophylaxis of malaria in patients aged 18 years of age and older.

60 Degrees Pharmaceuticals to Sponsor Pre-Clinical Studies of Tafenoquine Use in Candida spp, Including Candida auris

Retrieved on: 
화요일, 2월 20, 2024
Infection, Bangladesh Technical Education Board, Fungus, Hospital, Candida auris, NIAID, NIH, Marketing, FDA, Food, Tafenoquine, Risk, Malaria, Patient, Monash University, Oxidative stress, Ageing, Research, Fungal infection, Pharmaceutical industry

C. auris, a strain of fungal yeast, is an emerging pathogen that poses risk of serious infection in the bloodstream and elsewhere, especially in hospitalized patients.

Key Points: 
  • C. auris, a strain of fungal yeast, is an emerging pathogen that poses risk of serious infection in the bloodstream and elsewhere, especially in hospitalized patients.
  • The study will be conducted by Monash University in Melbourne, Australia, beginning in the second quarter of 2024.
  • “The rapid transmission of Candida auris in healthcare facilities is a very real threat and the need for a safe, effective treatment option is becoming more urgent every day,” said 60 Degrees Pharmaceuticals Chief Executive Officer and President, Geoff Dow.
  • Like other 8-aminoquinoline antimalarials, tafenoquine is expected to kill fungi by disrupting cellular responses to oxidative stress, differentiating it from other antifungals.

60 Degrees Pharmaceuticals Appoints Kristen Landon as Chief Commercial Officer

Retrieved on: 
목요일, 2월 8, 2024
Degree, Marketing, Senior, Abbott Laboratories, Fairleigh Dickinson University, Actavis, Novartis, Patient, Safety, FDA, IPO, Ageing, MBA, Communication, Babesiosis, Kean University, Tafenoquine, Infection, Malaria, Pharma, Business, Sprout, Pharmaceutical industry

WASHINGTON, Feb. 08, 2024 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP ; SXTPW) (“60P” or the “Company”), a pharmaceutical company focused on developing new medicines for infectious diseases, announced today it has appointed Kristen Landon to the newly created role of Chief Commercial Officer, effective immediately.

Key Points: 
  • WASHINGTON, Feb. 08, 2024 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP ; SXTPW) (“60P” or the “Company”), a pharmaceutical company focused on developing new medicines for infectious diseases, announced today it has appointed Kristen Landon to the newly created role of Chief Commercial Officer, effective immediately.
  • Ms. Landon is an accomplished commercial leader with over 26 years’ experience launching, building, and transforming commercial teams and brands in the pharmaceutical industry.
  • “We screened hundreds of applicants during the second half of 2023 and Kristen’s vision and directly relevant experience made her the ideal match for the position,” said Geoff Dow, PhD., 60 Degrees Pharma Chief Executive Officer.
  • Ms. Landon holds an MBA from Silberman College of Business at Fairleigh Dickinson University, and a Bachelor’s degree from Kean University.

60 Degrees Pharma Plans Pivotal Babesiosis Study with Tafenoquine Following Jan 17 FDA Meeting

Retrieved on: 
월요일, 1월 22, 2024
Ageing, Patient, Total, Notifiable disease, Feedback, Outline, Infection, Safety, Tafenoquine, FDA, Malaria, Observation, Type, Type C, Babesiosis, Trial of the century, Pharmaceutical industry

Following a Type C meeting with FDA on January 17, 2024, 60 Degrees Pharma (60P) now plans to conduct a pivotal clinical study in support of a future indication for tafenoquine for treatment of hospitalized babesiosis patients

Key Points: 
  • Following a Type C meeting with FDA on January 17, 2024, 60 Degrees Pharma (60P) now plans to conduct a pivotal clinical study in support of a future indication for tafenoquine for treatment of hospitalized babesiosis patients
    WASHINGTON, Jan. 22, 2024 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP ; SXTPW) (“60P” or the “Company”), a pharmaceutical company focused on developing new medicines for infectious diseases, announced today that, following a Type C meeting held on January 17, 2024 with the US Food and Drug Administration (FDA), the Company will move forward with a pivotal clinical study of tafenoquine in hospitalized babesiosis patients in the U.S.
  • In advance of the meeting, 60P provided to the FDA an information package that included a presentation of the unmet medical need for a new therapeutic for hospitalized babesiosis patients.
  • The FDA indicated in remarks during the meeting that the proposed study could be sufficient for regulatory approval, provided the Company uses a clinical endpoint rather than a surrogate marker.
  • Tafenoquine has not been proven to be effective for treatment or prevention of babesiosis and is not approved by the FDA for such an indication.

60 Degrees Pharma Announces IRB Approval of Phase IIA Study to Evaluate Tafenoquine for Babesiosis, an Emerging Tick-Borne Disease; Type C Meeting Re-Scheduled by FDA to January 17, 2024

Retrieved on: 
화요일, 12월 26, 2023
Babesiosis, Food, Risk, FDA, Type, Malaria, IRB, Coinfection, Tafenoquine, Observation, Patient, Safety, Infection, IIA, Pharmaceutical industry

The study aims to investigate the efficacy and safety of the ARAKODA® regimen of tafenoquine in combination with standard of care medications for treatment of hospitalized babesiosis patients at lower risk of relapse.

Key Points: 
  • The study aims to investigate the efficacy and safety of the ARAKODA® regimen of tafenoquine in combination with standard of care medications for treatment of hospitalized babesiosis patients at lower risk of relapse.
  • Additionally, the U.S. Food and Drug Administration (FDA) rescheduled the Company’s previously announced January 15 Type C meeting to January 17, 2024, due to a federal holiday.
  • The agenda and all material submitted by SXTP to FDA in support of the Type C meeting remain unchanged.
  • Tafenoquine has not been proven to be effective for treatment or prevention of babesiosis and is not approved by the FDA for such an indication.

60 Degrees Pharma Announces Type C Meeting with FDA to Discuss Development of Tafenoquine for Babesiosis, an Emerging Tick-Borne Disease

Retrieved on: 
수요일, 11월 15, 2023
Medicine, Safety, Food, Type, Literature, Tafenoquine, Primaquine, Patient, FDA, Infection, Babesiosis, Malaria, Pharmaceutical industry

The meeting will take place on January 15, 2024.

Key Points: 
  • The meeting will take place on January 15, 2024.
  • Tafenoquine is approved for malaria prophylaxis in the United States under the product name ARAKODA.
  • Tafenoquine has not been proven to be effective for treatment or prevention of babesiosis and is not approved by the FDA for such an indication.
  • The efficacy and safety of 8-aminoquinolines, a class of drugs that includes tafenoquine and primaquine, for prevention and treatment of malaria is well established.

60 Degrees Pharma to Present Review of Safety, Efficacy Data of 8-Aminoquinolines for Malaria and Babesiosis Treatment at ILADS Annual Scientific Meeting in Boston

Retrieved on: 
목요일, 10월 19, 2023
FDA, ILADS, Literature, International Lyme and Associated Diseases Society, Malaria, Doctor of Philosophy, Poster, Tafenoquine, Primaquine, Medicine, Infection, Babesiosis, Safety, Pharmaceutical industry

The poster will be presented by 60 Degrees Pharmaceuticals Chief Executive Officer, Geoff Dow, PhD.

Key Points: 
  • The poster will be presented by 60 Degrees Pharmaceuticals Chief Executive Officer, Geoff Dow, PhD.
  • Tafenoquine is approved for malaria prophylaxis in the United States under the product name ARAKODA®.
  • The sponsored symposium will feature a comprehensive review of the use of 8-aminoquinolines in treating malaria and babesiosis.
  • The efficacy and safety of 8-aminoquinolines, a class of drugs that includes tafenoquine and primaquine, for prevention and treatment of malaria is well established.