KTTA

Pasithea Therapeutics Announces Opening of Enrollment in the U.S. for its Phase 1 Trial of PAS-004

Retrieved on: 
Tuesday, February 13, 2024
BRAF, SAN, Investigational New Drug, PD, FDA, Food, RAS, Safety, RAF, Human, KTTA, Pharmacokinetics, Solubility, Patient, Half-life, MAPK, NF1, Mutation, IND, MEK, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif. and MIAMI, Feb. 13, 2024 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor, for the treatment of neurofibromatosis type 1 (NF1) and other cancer indications, today announced the activation of four clinical trial sites in the United States. These U.S. clinical trial sites in Texas and Virginia are now open and actively enrolling patients.

Key Points: 
  • These U.S. clinical trial sites in Texas and Virginia are now open and actively enrolling patients.
  • The Company's clinical development plan for PAS-004 following the Phase 1 study is to begin a Phase 2 clinical trial in NF1 pediatric and adult patients as soon as safety and PK are established.
  • There are also three other clinical trial sites in Eastern Europe that are expected to open in the coming months.
  • “Activating our four clinical trial sites in the U.S. is a significant milestone in Pasithea’s mission towards developing PAS-004 as a potential best-in-class next-generation MEK inhibitor.

Pasithea Therapeutics Announces Invention of Crystalline Form of PAS-004; Establishes Strengthened Intellectual Property (IP) Position

Retrieved on: 
Monday, January 8, 2024
Research, Chemistry, Patent, CMC, KTTA, Central nervous system, SAN, CNS, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif. and MIAMI, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a clinical stage biotechnology company focused on the discovery, research, and development of innovative treatments for Central Nervous System (CNS) disorders, today announced the invention of a crystalline form of PAS-004 which is captured in polymorph and stereoisomer patent filings that when issued we believe will extend patent protection to at least 2045.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif. and MIAMI, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a clinical stage biotechnology company focused on the discovery, research, and development of innovative treatments for Central Nervous System (CNS) disorders, today announced the invention of a crystalline form of PAS-004 which is captured in polymorph and stereoisomer patent filings that when issued we believe will extend patent protection to at least 2045.
  • Chief Development Officer Dr. Graeme Currie stated, “Through the invention of the crystal structure for PAS-004 and subsequent patent filings, we are pleased to extend and strengthen the PAS-004 patent portfolio which we believe extends current protection from 2032 to at least 2045.
  • We worked closely with Jones Day, a top global law firm with a premier IP biotech practice, to reach this important milestone.”
    Chief Executive Officer Dr. Tiago Reis Marques added, “Through additional chemistry, manufacturing, and controls (CMC) development we believe that we continue to increase the value of PAS-004.
  • We are pleased that our upcoming phase 1 dose escalation trial will utilize the newly invented crystalline drug substance.”

Pasithea Therapeutics Announces FDA Acceptance of IND Application to Evaluate PAS-004 in Advanced Cancer Patients

Retrieved on: 
Tuesday, January 2, 2024
NF1, MAPK, IND, Research, BRAF, FDA, SAN, Cancer, Pharmacokinetics, CNS, RAF, MEK, RAS, Patient, Safety, KTTA, Central nervous system, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif. and MIAMI, Jan. 02, 2024 (GLOBE NEWSWIRE) --  Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a biotechnology company focused on the discovery, research, and development of innovative treatments for Central Nervous System (CNS) disorders, today announced the Investigational New Drug Application (IND) clearance to proceed by the U.S. Federal Drug Administration (FDA) to evaluate PAS-004, a macrocyclic MEK (1/2) inhibitor, in patients with MAPK pathway driven advanced solid tumors with a documented RAS, RAF or NF1 mutation or patients who have failed BRAF/MEK inhibition. Pasithea expects to dose the first patient in the first quarter of 2024.

Key Points: 
  • Pasithea expects to dose the first patient in the first quarter of 2024.
  • The objectives of the dose escalation study are to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics as well as anti-tumor responses of PAS-004 as monotherapy in up to 36 advanced cancer patients with preliminary early data expected as early as Q3 2024.
  • “We believe PAS-004 has the potential to improve clinical responses in cancer patients as a monotherapy as well as provide a more tolerable and better dosing profile.
  • After we have established a preliminary recommended phase 2 dose, we will use this information to bridge to dosing for Neurofibromatosis type 1 patients.

Pasithea Therapeutics Announces Adjournment of Reconvened Meeting of Stockholders to December 29, 2023

Retrieved on: 
Thursday, December 28, 2023
Proxy, SAN, KTTA, Security (finance), Adjournment

The original record date of October 12, 2023 remains the same for the adjourned Meeting.

Key Points: 
  • The original record date of October 12, 2023 remains the same for the adjourned Meeting.
  • During this adjournment, the Company will continue to solicit votes from its stockholders in favor of the Adjourned Proposals in the Proxy Statement.
  • Pasithea encourages all stockholders as of the record date on October 12, 2023 who have not yet voted on the Adjourned Proposals to do so promptly.
  • Stockholders wishing to vote on the Adjourned Proposals should contact the Company’s proxy solicitor, Alliance Advisors, toll free at (888) 490-5085.

Pasithea Therapeutics Announces Positive In Vivo Preclinical Efficacy Data for PAS-004 from NRAS Mutation Cancer Xenograft Models

Retrieved on: 
Monday, December 11, 2023
NF1, NCI-H1299, MAPK, IND, Research, BRAF, FDA, Lung cancer, Half-life, SAN, Human, Cancer, LMNA, CNS, RAF, MEK, Liver cancer, RAS, Patient, KTTA, Central nervous system, Binimetinib, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif. and MIAMI, Dec. 11, 2023 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a biotechnology company focused on the discovery, research, and development of innovative treatments for Central Nervous System (CNS) disorders, today announced positive preclinical results from two in vivo studies evaluating the anti-tumor efficacy of PAS-004 in NRAS mutation cancer xenograft models.

Key Points: 
  • In the first study, PAS-004 exhibited dose-dependent anti-tumor efficacy in the lung cancer NCI-H1299 cell-line-derived xenograft model.
  • PAS-004 at dose levels of 10 mg/kg and 5 mg/kg, once daily, significantly inhibited tumor growth as compared to vehicle control.
  • The anti-tumor efficacy of PAS-004, when taken at equivalent doses was shown to be superior to that of binimetinib and selumetinib.
  • In the second study, PAS-004 exhibited dose-dependent anti-tumor efficacy in the liver cancer xHepG2 cell-line-derived xenograft model.

Pasithea Therapeutics Announces Adjournment of 2023 Annual Meeting of Stockholders

Retrieved on: 
Wednesday, November 29, 2023
Proxy, SAN, Annual general meeting, Annual, Proxy card, KTTA, Security (finance), Holding company

SOUTH SAN FRANCISCO, Calif. and MIAMI, Nov. 29, 2023 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (“Pasithea” or the “Company”) (NASDAQ: KTTA), today announced that its annual meeting of stockholders held on November 29, 2023 (the “Annual Meeting”) was convened and then adjourned, without conducting any business, in order to provide stockholders additional time within which to vote on the proposals described in the Company’s definitive proxy statement filed with the Securities and Exchange Commission (“SEC”) on October 26, 2023 (the “Proxy Statement”).

Key Points: 
  • SOUTH SAN FRANCISCO, Calif. and MIAMI, Nov. 29, 2023 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (“Pasithea” or the “Company”) (NASDAQ: KTTA), today announced that its annual meeting of stockholders held on November 29, 2023 (the “Annual Meeting”) was convened and then adjourned, without conducting any business, in order to provide stockholders additional time within which to vote on the proposals described in the Company’s definitive proxy statement filed with the Securities and Exchange Commission (“SEC”) on October 26, 2023 (the “Proxy Statement”).
  • The adjourned Annual Meeting will reconvene on December 19, 2023 at 9:00 a.m. Eastern Time at www.virtualshareholdermeeting.com/KTTA2023 .
  • The original record date of October 12, 2023 remains the same for the adjourned Annual Meeting.
  • All proposals set forth in the Proxy Statement will be voted upon at the adjourned Annual Meeting to be held on December 19, 2023.

Pasithea Therapeutics Announces Outcome of Pre-IND Meeting with FDA for PAS-004 Clinical Development

Retrieved on: 
Wednesday, November 29, 2023
NF1, Food, Research, BRAF, FDA, New Drug Application, CNS, RAF, NRAS, RAS, Patient, KTTA, Central nervous system, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif. and MIAMI, Nov. 29, 2023 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a biotechnology company focused on the discovery, research, and development of innovative treatments for Central Nervous System (CNS) disorders, announced receipt of written responses to questions submitted for a Type 2 pre-Investigational New Drug Application (IND) meeting with the U.S. Food and Drug Administration (FDA) regarding clinical development plan for PAS-004. The FDA's positive feedback and guidance include a recommendation to begin dosing in patients who will benefit from treatment rather than in healthy volunteers. PAS-004 was granted orphan drug designation for the treatment of NF1 in November 2020.

Key Points: 
  • -- Pasithea plans to begin PAS-004 Phase 1 dose escalation trial in advanced solid tumor patients harboring RAS, RAF and NF1 mutations --
    SOUTH SAN FRANCISCO, Calif. and MIAMI, Nov. 29, 2023 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a biotechnology company focused on the discovery, research, and development of innovative treatments for Central Nervous System (CNS) disorders, announced receipt of written responses to questions submitted for a Type 2 pre-Investigational New Drug Application (IND) meeting with the U.S. Food and Drug Administration (FDA) regarding clinical development plan for PAS-004.
  • The FDA's positive feedback and guidance include a recommendation to begin dosing in patients who will benefit from treatment rather than in healthy volunteers.
  • PAS-004 was granted orphan drug designation for the treatment of NF1 in November 2020.
  • “We are pleased with our PAS-004 Pre-IND meeting minutes which guide us to dose patients who will benefit from treatment.

Pasithea Therapeutics Selects PAS-003 Lead Development Candidate, a Humanized Monoclonal Antibody that Targets α5β1 Integrin for the Treatment of both Sporadic and Familial ALS

Retrieved on: 
Thursday, November 9, 2023
Survival, PNAS, IND, Stanford University, Patent, SOD1, KTTA, Clinical professor, Behavior, National academy, CNS, Natalizumab, Research, HIV disease progression rates, FN, Oregon Health & Science University, Disease, ALS, Multiple sclerosis, Integrin, Patient, Mayo Clinic, MS, SAN, Central nervous system, Pharmaceutical industry, Pasithea (Charites), Nature

SOUTH SAN FRANCISCO, Calif. and MIAMI, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a biotechnology company focused on the discovery, research, and development of innovative treatments for central nervous system (CNS) disorders, announced today that it has selected a lead therapeutic candidate for its PAS-003 program, a proprietary humanized monoclonal antibody (mAb) that targets α5β1 integrin, a protein found to be overexpressed in both human and mouse subjects with amyotrophic lateral sclerosis (ALS).

Key Points: 
  • Scientists at Pasithea have performed extensive mAb screening and characterization to enable selection of a lead therapeutic candidate with optimal properties for the treatment of ALS.
  • This work included further validation of α5β1 integrin as a target in both familial (SOD1) and sporadic (TDP-43) ALS mouse models with reproducible improvements on behavior and survival.
  • Extensive mechanism of action studies link disease model efficacy to effects on the migration and adhesion of immune cells.
  • Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea commented, “We have chosen the most optimal anti-α5β1 humanized mAb for the treatment of both sporadic and familial ALS.

Pasithea Therapeutics Corp. Announces Final Results of Tender Offer

Retrieved on: 
Thursday, September 14, 2023
Central nervous system, PALO, Research, MEK, CNS, Suite, Share repurchase, KTTA, Hand, ALS, Alpha-5 beta-1, Pharmaceutical industry, Cryptocurrency, Security (finance), Telephone, Pasithea (Charites)

The tender offer expired at 5:00 p.m. on September 8, 2023 and was funded entirely through the Company’s cash on hand.

Key Points: 
  • The tender offer expired at 5:00 p.m. on September 8, 2023 and was funded entirely through the Company’s cash on hand.
  • Based on the final results, a total of 5,323,451 shares of common stock were validly tendered and not withdrawn.
  • Broadridge Corporate Issuer Solutions, LLC (“Broadridge”), the depositary for the tender offer, will promptly pay for all of the shares of common stock accepted for purchase in accordance with the terms and conditions of the tender offer.
  • For all questions relating to the tender offer, please contact: Secretary, Pasithea Therapeutics Corp., 1111 Lincoln Road, Suite 500, Miami Beach, Florida 33139, Email [email protected], Telephone (786) 977-3380 or Broadridge Corporate Issuer Solutions, LLC, Telephone (855) 793-5068, email [email protected].

Pasithea Therapeutics to Participate in H.C. Wainwright 25th Annual Global Investment Conference

Retrieved on: 
Thursday, September 7, 2023
CNS, KTTA, Central nervous system, Research, Conference, PALO, Pharmaceutical industry, Mail

PALO ALTO, Calif. and MIAMI, Fla., Sept. 07, 2023 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a biotechnology company focused on the discovery, research, and development of innovative treatments for central nervous system (CNS) disorders, announced today that Pasithea's management team will participate in the H.C. Wainwright 25th Annual Global Investment Conference, to be held in New York City, September 11-13.

Key Points: 
  • PALO ALTO, Calif. and MIAMI, Fla., Sept. 07, 2023 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a biotechnology company focused on the discovery, research, and development of innovative treatments for central nervous system (CNS) disorders, announced today that Pasithea's management team will participate in the H.C. Wainwright 25th Annual Global Investment Conference, to be held in New York City, September 11-13.
  • Attendees interested in 1 x 1 meetings are invited to request them through the conference’s meeting scheduler at [email protected] or by calling or emailing the company contact below.