Peripheral T-cell lymphoma

Cornerstone Pharmaceuticals Announces Published Data on CPI-613® (Devimistat) as an Effective Approach to Targeting Carcinoma Catabolism

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星期四, 六月 16, 2022
Cancer, Devimistat, FDA, Therapy, Hope, Mitochondrion, Cholangiocarcinoma, Regulation of tobacco by the U.S. Food and Drug Administration, CEO, Survival, European Medicines Agency, PLOS, TCA, Carcinoma, Myelodysplastic syndrome, Peripheral T-cell lymphoma, Food, EMA, Patient, Terminology, MDS, Cornerstone, GLOBE, Pharmaceutical industry

Cranbury, N.J., June 16, 2022 (GLOBE NEWSWIRE) -- Cornerstone Pharmaceuticals, Inc. (Cornerstone or the Company), a company focused on rare cancer therapeutics and formerly known as Rafael Pharmaceuticals, today announced a publication on preclinical data supporting CPI-613 (devimistat) targeting carcinoma catabolism.

Key Points: 
  • Cranbury, N.J., June 16, 2022 (GLOBE NEWSWIRE) -- Cornerstone Pharmaceuticals, Inc. (Cornerstone or the Company), a company focused on rare cancer therapeutics and formerly known as Rafael Pharmaceuticals, today announced a publication on preclinical data supporting CPI-613 (devimistat) targeting carcinoma catabolism.
  • By suppressing the TCA hub, indispensable to many metabolic pathways, devimistat substantially reduces the effective redundancy of tumor catabolism.
  • The authors of the study note that their preclinical results indicate a clearly defined, detailed, potentially general class of approaches to improved clinical targeting of carcinoma catabolism.
  • Cornerstone Pharmaceuticals (Cornerstone) is committed to the development of therapies for rare cancers that have few to no treatment options available.

Kymera Therapeutics Receives FDA Orphan Drug Designation for KT-333, a First-in-Class, Investigational STAT3 Degrader for the Treatment of Peripheral T-Cell Lymphoma

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星期三, 六月 1, 2022
Science, Entrepreneurship, Adult, Lymph, Biotechnology, Doctor of Philosophy, Food, Gastrointestinal tract, LinkedIn, Peripheral, United, Aggressive lymphoma, CEO, Boston, Security (finance), Disease, Cancer, U.S. Securities and Exchange Commission, STAT3, Nasdaq, Peripheral T-cell lymphoma, Therapy, Lymphoma, Risk, FDA, GLOBE, Patient, Private Securities Litigation Reform Act, Boston Business Journal, COVID-19, NASDAQ, Twitter, Diagnosis, Cytokine, Degenerative disease, Compte rendu, Skin, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Neoplasm, Lymphatic system, Safety, Pharmaceutical industry, PTCL, Black Majesty

The Orphan Drug Designation highlights the potential of this first-in-class heterobifunctional degrader to transform the treatment of PTCL by targeting STAT3, a protein that has historically been undruggable, said Nello Mainolfi, PhD, Co-Founder, President and CEO, Kymera Therapeutics.

Key Points: 
  • The Orphan Drug Designation highlights the potential of this first-in-class heterobifunctional degrader to transform the treatment of PTCL by targeting STAT3, a protein that has historically been undruggable, said Nello Mainolfi, PhD, Co-Founder, President and CEO, Kymera Therapeutics.
  • TheFDA'sOrphan Drug Designation program provides orphan status to drugs defined as those intended for the treatment, diagnosis or prevention of rare diseases that affect fewer than 200,000 people inthe United States.
  • Orphan drug designation qualifies the sponsor of the drug for certain development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions and seven-year marketing exclusivity upon FDA approval.
  • KT-333 is a potent and selective heterobifunctional small molecule protein degrader which can mediate degradation of the STAT3 protein.

Cornerstone Pharmaceuticals to Present Pancreatic Cancer, Clear Cell Sarcoma and Biliary Tract Cancer Research Featuring CPI-613® (Devimistat) at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting

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星期三, 六月 1, 2022
Clear cell sarcoma, Cornerstone, Company, Research, Society, Mitochondrion, EMA, American Society of Clinical Oncology, Food, CEO, Partnership, Disease, ASCO, Devimistat, Cancer, Hope, Annual general meeting, Pancreatic cancer, Therapy, Cholangiocarcinoma, Cisplatin, MDS, FDA, 2021 Essex County Council election, GLOBE, Patient, CCS, Myelodysplastic syndrome, CDT, European Medicines Agency, Poster, Peripheral T-cell lymphoma, Regulation of tobacco by the U.S. Food and Drug Administration, Terminology, McCormick Place, Pharmaceutical industry, Medical imaging, Paint

We are incredibly proud to have promising research findings to share in the three rare cancer areas that were focused on at ASCOs Annual Meeting, said Sanjeev Luther, President and CEO of Cornerstone Pharmaceuticals.

Key Points: 
  • We are incredibly proud to have promising research findings to share in the three rare cancer areas that were focused on at ASCOs Annual Meeting, said Sanjeev Luther, President and CEO of Cornerstone Pharmaceuticals.
  • Its an honor to discuss our research in pancreatic cancer with some of the brightest minds in clinical oncology at ASCO, said Dr. Philip.
  • Currently, patients who live with relapsed or refractory clear cell sarcoma (CCS) have limited treatment options, said Dr. Agulnik.
  • Cornerstone Pharmaceuticals (Cornerstone) is committed to the development of therapies for rare cancers that have few to no treatment options available.

AVM Biotechnology to Present Poster Highlighting the Effects of AVM0703 Against Solid Tumors and Blood Cancers at the 2022 ASCO Annual Meeting

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星期三, 六月 1, 2022
Research, General Health, Professional Services, Pharmaceutical, Oncology, Venture Capital, Hospitals, Clinical Trials, Science, Biotechnology, Other Science, Health, Human, Degenerative disease, Development of the human body, Research, Cell, Society, AVM, Animal, ASCO, Blood, Annual general meeting, Peripheral T-cell lymphoma, Multimedia, American Society of Clinical Oncology, FDA, 2021 Essex County Council election, Patient, Biotechnology, Private Securities Litigation Reform Act, PTCL, CSO, Natural killer T cell, Clinical trial, Drug development, Adoptive cell transfer, Cancer, Medical imaging, Copper, Pharmaceutical industry

AVM Biotechnology, today announced that its abstract, The effects of AVM0703 mobilization of endogenous gamma delta invariant TCR+ bi-specific Natural Killer T-like cells against solid tumors and blood cancers has been accepted for a poster presentation at the 2022 ASCO (American Society of Clinical Oncology) Annual Meeting in Chicago.

Key Points: 
  • AVM Biotechnology, today announced that its abstract, The effects of AVM0703 mobilization of endogenous gamma delta invariant TCR+ bi-specific Natural Killer T-like cells against solid tumors and blood cancers has been accepted for a poster presentation at the 2022 ASCO (American Society of Clinical Oncology) Annual Meeting in Chicago.
  • Founder and CSO, Dr. Theresa Deisher, will present this research on Sunday, June 5th, 2022, in the Developmental Therapeutics Immunotherapy tract.
  • View the full release here: https://www.businesswire.com/news/home/20220601005424/en/
    The ASCO Annual Meeting showcases cutting-edge research in clinical oncology and is the most influential and prominent scientific gathering of the clinical oncology community.
  • AVM0703 mobilizes endogenous bi-specific gamma delta TCR+ invariant TCR+ Natural Killer T-like cells resulting in cancer death within hours of administration.

Citius Pharmaceuticals, Inc. Announces Intention to Spinoff Late-Stage Oncology Asset, I/ONTAK, into a New Standalone Publicly Traded Company

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星期三, 五月 25, 2022
COVID-19, U.S. Securities and Exchange Commission, Company, Immunotherapy, Regulation of tobacco by the U.S. Food and Drug Administration, Food, Pivotal, T-cell lymphoma, Peripheral T-cell lymphoma, Potency (pharmacology), Multimedia, Patient, Protein, Quality of life, Diphtheria, CGMP, BLA, PTCL, Research, Patent, FDA, Securities Act of 1933, Securities Exchange Act of 1934, Intention, Forward-looking statement, Program, IL-2R, Drug Quality and Security Act, ODD, Sale, Calendar, IPO, Therapy, Regulation, NewCo, Fast Track, SEC, Growth, Interleukin, Annual report, CTCL, CEO, Pharmaceutical industry, Security (finance), Nasdaq, Citius, Altius, Fortius

CRANFORD, N.J., May 25, 2022 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, today announced that it intends to split the Company's assets into two separate publicly-traded entities. Citius plans to form a new company (NewCo) focused on developing and commercializing I/ONTAK, for which a Phase 3 trial was completed in December 2021 and a biologics license application (BLA) is being planned for submission in the second half of 2022. The Company's other pipeline assets, including Mino-Lok®, would remain at Citius. Citius would continue to trade on the Nasdaq exchange under its current ticker CTXR. The strategic action is intended to optimize organizational resources and investment capital to support the successful execution of each development program.

Key Points: 
  • The strategic action is intended to optimize organizational resources and investment capital to support the successful execution of each development program.
  • Upon completion of the transactions, NewCo would be a pure-play oncology-focused biopharmaceutical company.
  • Our intention is that the spinoff will be non-dilutive and tax-fee to Citius shareholders," stated Leonard Mazur, Chairman and CEO of Citius.
  • Citius intends the spinoff to be accomplished through an initial public offering (IPO) and pro rata distribution of stock in the NewCo to Citius shareholders.

European Medicines Agency Grants Orphan Drug Designation to Cornerstone Pharmaceuticals’ CPI-613® (Devimistat) for Treatment of Patients with Advanced Unresectable Biliary Tract Cancer

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星期二, 五月 24, 2022
Cancer, Acute myeloid leukemia, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Criticism of the Food and Drug Administration, Food, MDS, Enzyme, Survival, Peripheral T-cell lymphoma, Devimistat, European Medicines Agency, Patient, AML, TCA, Research, Hope, FDA, Cholangiocarcinoma, EMA, Cisplatin, Terminology, Prognosis, Therapy, Biliary tract, Pancreatic cancer, Mitochondrion, Myelodysplastic syndrome, CEO, GLOBE, Pharmaceutical industry, Dietary supplement, MBBS

Biliary tract cancer is considered rare and aggressive, with a large gap in effective treatment options, said Sanjeev Luther, President and CEO of Cornerstone Pharmaceuticals.

Key Points: 
  • Biliary tract cancer is considered rare and aggressive, with a large gap in effective treatment options, said Sanjeev Luther, President and CEO of Cornerstone Pharmaceuticals.
  • The Food and Drug Administration (FDA) has granted orphan drug designation for devimistat in seven indications in the United States, including in biliary tract cancer.
  • Devimistat is a potentially life-saving therapy, bringing hope to patients and loved ones affected by biliary tract cancer.
  • The European Medicines Agency (EMA) has granted orphan drug designation to devimistat for pancreatic cancer, acute myeloid leukemia and Burkitts lymphoma.

Rafael Pharmaceuticals, Inc. Announces Corporate Name Change to Cornerstone Pharmaceuticals, Inc.

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星期四, 五月 19, 2022
Cornerstone, Cancer, Physician, Regulation of tobacco by the U.S. Food and Drug Administration, Food, MDS, Peripheral T-cell lymphoma, Devimistat, Director, European Medicines Agency, Patient, Clear cell sarcoma, FDA, Hope, EMA, Board, Terminology, Cholangiocarcinoma, Therapy, Mitochondrion, Myelodysplastic syndrome, CEO, GLOBE, Pharmaceutical industry, Q2

Over these last few months, the Board of Directors has worked to determine the direction of our company.

Key Points: 
  • Over these last few months, the Board of Directors has worked to determine the direction of our company.
  • Cornerstone Pharmaceuticals (Cornerstone) is committed to the development of therapies for rare cancers that have few to no treatment options available.
  • We undertake no duty to update any of the forward-looking statements, whether as a result of new information, future events or otherwise.
  • In light of the foregoing, readers are cautioned not to place undue reliance on such forward-looking statements.

Citius Pharmaceuticals to Present at the H.C. Wainwright Global Investment Conference on May 24, 2022

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星期三, 五月 18, 2022
Company, Immunotherapy, Regulation of tobacco by the U.S. Food and Drug Administration, Food, Pivotal, Peripheral T-cell lymphoma, Potency (pharmacology), T-cell lymphoma, Multimedia, Patient, COVID-19, PTCL, FDA, Conference, IL-2R, Fast Track, Virtual, CTCL, CEO, Pharmaceutical industry, Citius, Altius, Fortius

CRANFORD, N.J., May 18, 2022 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products,today announced that it will present at the H.C. Wainwright GlobalInvestment Conference being held May 23-26, 2022.

Key Points: 
  • CRANFORD, N.J., May 18, 2022 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products,today announced that it will present at the H.C. Wainwright GlobalInvestment Conference being held May 23-26, 2022.
  • Leonard Mazur, Chairman and CEO of Citius, will discuss the Company's recent business developments and upcoming milestones.
  • Virtual and at the Fontainebleau Miami Beach Hotel, Miami Beach, Florida
    Interested parties may schedule 1-on-1 meetings with Citius management by registering through the event platform or contacting the Company's investor relations team.
  • I/ONTAK has received orphan drug designation by the FDA for the treatment of CTCL and peripheral T-cell lymphoma (PTCL).

Citius Pharmaceuticals, Inc. Reports Fiscal Second Quarter 2022 Financial Results and Provides Business Update

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星期四, 五月 12, 2022
COVID-19, U.S. Securities and Exchange Commission, Risk, Company, Consultant, Immunotherapy, G&A, Regulation of tobacco by the U.S. Food and Drug Administration, Infection, Food, Pivotal, Peripheral T-cell lymphoma, T-cell lymphoma, Potency (pharmacology), Patient, Insurance, Quality of life, CGMP, BLA, PTCL, Research, Patent, FDA, Securities Act of 1933, Accounting, Securities Exchange Act of 1934, Hemorrhoid, CRO, Forward-looking statement, IL-2R, Drug Quality and Security Act, Calendar, Regulation, Fast Track, SEC, Annual report, CTCL, CEO, Pharmaceutical industry, Security (finance), Fine chemical, Online gambling, Airline, Citius, Altius, Fortius, Novellus Systems

CRANFORD, N.J., May 12, 2022 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, today reported business and financial results for the second fiscal quarter of 2022 ended March 31, 2022.

Key Points: 
  • "The Citius balance sheet remains healthy with $55.8 million in cash available to execute our near-term plans.
  • As stewards of Citius shareholders' capital, we focus on creating long-term value in the business and will continue to evaluate all strategic and financial options available to us.
  • SECOND QUARTER ENDED MARCH 31, 2022 Financial Results:
    As of March 31, 2022, the Company had $55.8 million in cash and cash equivalents and no debt.
  • For the fiscal quarter ended March 31, 2022, stock-based compensation expense was $1.0 million as compared to $0.3 million for the prior year period.

Citius Pharmaceuticals to Accelerate Phase 3 Mino-Lok Trial by Expanding Trial Sites Internationally

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星期五, 五月 6, 2022
Dermatology, COVID-19, CTCL, Forward-looking statement, LLC, Control, Infectious Diseases Society of America, T-cell lymphoma, IDSA, Company, NDA, Securities Act of 1933, Securities Exchange Act of 1934, PTCL, Safety, Food, Time, CGMP, Patient, TOC, Immunotherapy, CVC, Population, Nephrology, IL-2R, Clinical trial, FDA, Annual report, MLT, Drug Quality and Security Act, Patent, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, U.S. Securities and Exchange Commission, CRO, New Drug Application, Hospital, Minocycline, Neurology, Multimedia, Potency (pharmacology), Fast Track, Quality of life, Pivotal, SEC, Solution, CEO, Regulation, ITT, Research, Peripheral T-cell lymphoma, Pharmaceutical industry, Citius, Altius, Fortius

CRANFORD, N.J. , May 6, 2022 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, today announced that it has selected Biorasi, LLC ("Biorasi"), a global clinical research organization (CRO), to help expand the Company's Phase 3 Mino-Lok trial to additional sites outside the United States. If approved, Mino-Lok would be the first-and-only antibiotic lock solution FDA-approved to salvage infected central venous catheters (CVCs) causing catheter-related blood stream infections (CRBSIs).

Key Points: 
  • If approved, Mino-Lok would be the first-and-only antibiotic lock solution FDA-approved to salvage infected central venous catheters (CVCs) causing catheter-related blood stream infections (CRBSIs).
  • "Citius is pleased to collaborate with Biorasi to expand the Mino-Lok trial to include international clinical sites, as originally planned.
  • We paused our ex-U.S. strategy as COVID-19 spread across the globe and hospitals halted non-COVID trials.
  • "We are committed to continuing to recruit patients until we reach the minimum required trial events, as per FDA guidance and outlined in our trial protocol to achieve statistically significant results.