Trial of the century

PharmaTher Holdings Provides Update for KETARX™ (Racemic Ketamine) Development Programs and Expected Milestones for 2023

Retrieved on: 
Wednesday, January 11, 2023

TORONTO, Jan. 11, 2023 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a leader in specialty ketamine pharmaceuticals, today provided an update for its clinical development programs and milestones for 2023 with KETARX™ (racemic ketamine) as a potential treatment for mental health, neurological and pain disorders.

Key Points: 
  • Of the three forms of ketamine, only racemic ketamine and S-ketamine products have been approved by FDA.
  • The Company recently completed the development of the microneedle patch system for the intradermal delivery of sustained low-dose ketamine.
  • This milestone has enabled progression toward process validation and the manufacturing of cGMP clinical materials to support ongoing clinical development.
  • Upon completion of the study, PharmaTher aims to seek guidance from the FDA to determine the final clinical development plan.

BioXcel Therapeutics Announces Promising Top-Line Results from Phase 2 Trial of BXCL701 in Aggressive Form of Rare Prostate Cancer

Retrieved on: 
Wednesday, January 11, 2023

NEW HAVEN, Conn., Jan. 11, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced promising top-line data from its Phase 2 trial of BXCL701, the Company's investigational, oral innate immune activator, in combination with KEYTRUDA® (pembrolizumab) in small cell neuroendocrine metastatic castration-resistant prostate cancer (SCNC) patients. Full data have been submitted to the 2023 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU).

Key Points: 
  • Full data have been submitted to the 2023 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU).
  • In 2022, there were an estimated 268,5001 new prostate cancer patients, with approximately 10,740 patients progressing to SCNC.
  • The Phase 2a trial is an open-label, multicenter study to evaluate the safety and efficacy of BXCL701 in combination with pembrolizumab in men with SCNC.
  • The primary endpoint of the trial is a composite response rate defined as RECIST 1.1 and/or PSA50 and/or CTC count conversion.

ProKidney Announces Publication of Trial Design for Phase 2 Multicenter Clinical Trial of REACT for Late Stage 4 Diabetes-Related Chronic Kidney Disease

Retrieved on: 
Tuesday, January 10, 2023

WINSTON-SALEM, N.C., Jan. 10, 2023 (GLOBE NEWSWIRE) -- ProKidney Corp. (Nasdaq: PROK) (“ProKidney”), a leading late clinical-stage cellular therapeutics company focused on chronic kidney disease (CKD), today announced the publication of the trial design and early data analysis from REGEN-003, a Phase 2 clinical study of Renal Autologous Cell Therapy (REACT®), in the Journal of Blood Purification. The paper, titled Renal Autologous Cell Therapy (REACT) in Type 2 Diabetes with Late Stage 4 Diabetes-Related Chronic Kidney Disease: Trial Design and Early Analysis, was published online and will appear later this year in the print edition of the Journal (DOI: doi.org/10.1159/000527582).

Key Points: 
  • The paper, titled Renal Autologous Cell Therapy (REACT) in Type 2 Diabetes with Late Stage 4 Diabetes-Related Chronic Kidney Disease: Trial Design and Early Analysis, was published online and will appear later this year in the print edition of the Journal (DOI: doi.org/10.1159/000527582 ).
  • “This is a high-risk patient population with seriously reduced kidney function.
  • At 15 months, two patients (20%) had preservation of their kidney function and had not advanced to renal replacement therapy.
  • We believe that REACT has the potential to have a significant, positive impact on patients’ health and quality of life.

Silo Pharma Advances Clinical Study Analyzing Effects of Psilocybin on Inflammation

Retrieved on: 
Tuesday, January 10, 2023

ENGLEWOOD CLIFFS, NJ, Jan. 10, 2023 (GLOBE NEWSWIRE) --  Silo Pharma, Inc. (Nasdaq: SILO) (“the Company”), a developmental stage biopharmaceutical company focused on merging traditional therapeutics with psychedelic research, today announced a progress update on its sponsored research study with the University of California, San Francisco (UCSF) examining psilocybin’s effect on inflammatory activity in humans. The clinical study evaluates three populations of patients suffering from Parkinson's disease, bipolar disorder, and chronic pain.

Key Points: 
  • The clinical study evaluates three populations of patients suffering from Parkinson's disease, bipolar disorder, and chronic pain.
  • Eric Weisblum, Chief Executive Officer of Silo Pharma, commented, “The UCSF research team is making progress on the clinical trial.
  • Utilizing Psilocybin in this study in a regimented dosing pattern, we hope to gain significant data both in mechanism of action and potential biomarker for personalization of psilocybin therapy.
  • Data collection is expected to begin in early 2023 for the bipolar study, and in April 2023 for the chronic pain study patients.

Jasper Therapeutics Announces Development Prioritization of Briquilimab in Chronic Diseases, Including Urticaria and Lower-Risk MDS, and Stem Cell Transplant for Sickle Cell Disease and Other Rare Diseases

Retrieved on: 
Tuesday, January 10, 2023

This portfolio includes a new program on chronic urticaria, along with the Company’s existing programs for lower-risk myelodysplastic syndrome (MDS), sickle cell disease, Fanconi anemia and severe combined immunodeficiency (SCID).

Key Points: 
  • This portfolio includes a new program on chronic urticaria, along with the Company’s existing programs for lower-risk myelodysplastic syndrome (MDS), sickle cell disease, Fanconi anemia and severe combined immunodeficiency (SCID).
  • Based on preclinical and clinical studies showing inhibition of c-Kit signaling, depletion of mast cells in skin and lung and extended pharmacokinetics of subcutaneous dosing, the Company has prioritized rapidly starting a clinical study in severe chronic urticaria.
  • Clinical studies with briquilimab and investigational agents from other companies suggest that targeting c-Kit has strong therapeutic potential for chronic mast cell diseases such as urticaria and allergic asthma.
  • “We believe prioritizing these opportunities provides the best path forward to near-term, clinical milestones for patients and value creation for investors,” added Mr. Martell.

BriaCell Announces New Patent Issuance, Bria-OTS™ IND Timing Guidance, and Additional Clinical Sites to Boost Enrolment

Retrieved on: 
Tuesday, January 10, 2023

BriaCell expects to initiate its Bria-OTS™ clinical study under an Investigational New Drug Application (IND) in the first half of 2023, in accordance with FDA guidance.

Key Points: 
  • BriaCell expects to initiate its Bria-OTS™ clinical study under an Investigational New Drug Application (IND) in the first half of 2023, in accordance with FDA guidance.
  • The patent will issue on January 24, 2023 as US Patent No.
  • Additionally, BriaCell was awarded an Australian patent (Patent No.
  • BriaCell currently holds multiple issued patents and pending patent applications to cover its whole-cell immunotherapy’s composition of matter and method of use worldwide.

VERU INC. (NASDAQ: VERU) SHAREHOLDER CLASS ACTION ALERT: Bernstein Liebhard LLP Reminds Investors of the Deadline to File a Lead Plaintiff Motion in a Securities Class Action Lawsuit Against Veru Inc. (NASDAQ: VERU)

Retrieved on: 
Tuesday, January 10, 2023

NEW YORK, Jan. 10, 2023 (GLOBE NEWSWIRE) -- Bernstein Liebhard LLP, a nationally acclaimed investor rights law firm, reminds investors of the deadline to file a lead plaintiff motion in a securities class action lawsuit that has been filed on behalf of investors who purchased or acquired the common stock of Veru Inc. (“Veru” or the “Company”) (NASDAQ: VERU) between May 11, 2022 and November 9, 2022, inclusive (the “Class Period”). The lawsuit was filed in the United States District Court for the Southern District of Florida and alleges violations of the Securities Exchange Act of 1934.

Key Points: 
  • Shareholder Class Action Lawsuit or contact Peter Allocco at (212) 951-2030 or [email protected] to discuss your rights.
  • The lawsuit was filed in the United States District Court for the Southern District of Florida and alleges violations of the Securities Exchange Act of 1934.
  • Veru is primarily an oncology-based biopharmaceutical company that develops drugs for the management of breast and prostate cancers.
  • The law firm responsible for this advertisement is Bernstein Liebhard LLP, 10 East 40th Street, New York, New York 10016, (212) 779-1414.

CORRECTING and REPLACING --Merus Provides 2023 Outlook

Retrieved on: 
Monday, January 9, 2023

UTRECHT, The Netherlands and CAMBRIDGE, Mass., Jan. 09, 2023 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) (“Merus”, the “Company,” “we”, or “our”), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®), today provided its 2023 outlook.

Key Points: 
  • The corrected release follows:
    UTRECHT, The Netherlands and CAMBRIDGE, Mass., Jan. 09, 2023 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) (“Merus”, the “Company,” “we”, or “our”), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®), today provided its 2023 outlook.
  • “2023 looks to be another productive year for Merus with multiple value-creating clinical updates throughout the year.
  • Merus plans to provide an initial clinical data update on Zeno in CRPC in the second half of 2023.
  • Merus plans to provide a clinical update for petosemtamab at a medical conference in the first half of 2023.

Atreca Appoints Philippe Bishop, MD as Chief Medical Officer

Retrieved on: 
Monday, January 9, 2023

SAN CARLOS, Calif., Jan. 09, 2023 (GLOBE NEWSWIRE) -- Atreca, Inc. (Atreca) (NASDAQ: BCEL), a clinical-stage biotechnology company focused on developing novel therapeutics generated through a unique discovery platform based on interrogation of the active human immune response, today announced the appointment of Philippe Bishop, MD, as Chief Medical Officer (CMO), effective immediately.

Key Points: 
  • SAN CARLOS, Calif., Jan. 09, 2023 (GLOBE NEWSWIRE) -- Atreca, Inc. (Atreca) (NASDAQ: BCEL), a clinical-stage biotechnology company focused on developing novel therapeutics generated through a unique discovery platform based on interrogation of the active human immune response, today announced the appointment of Philippe Bishop, MD, as Chief Medical Officer (CMO), effective immediately.
  • Bishop is a tremendous addition to the Atreca team at an important time in the clinical development of ATRC-101.
  • As an accomplished executive and medical oncologist with extensive experience in cancer drug development, his leadership and expertise will be invaluable as we continue to advance ATRC-101, as well as our earlier stage programs,” said John Orwin, Chief Executive Officer of Atreca.
  • This award was granted as an inducement material to Dr. Bishop entering into employment with Atreca in accordance with Nasdaq Listing Rule 5635(c)(4).

Pharvaris Provides Regulatory, Clinical, and Corporate Updates

Retrieved on: 
Monday, January 9, 2023

ZUG, Switzerland, Jan. 09, 2023 (GLOBE NEWSWIRE) -- Pharvaris (Nasdaq: PHVS), a clinical-stage company developing novel, oral bradykinin-B2-receptor antagonists to treat and prevent hereditary angioedema (HAE) attacks, today provided business updates and company highlights.

Key Points: 
  • ZUG, Switzerland, Jan. 09, 2023 (GLOBE NEWSWIRE) -- Pharvaris (Nasdaq: PHVS), a clinical-stage company developing novel, oral bradykinin-B2-receptor antagonists to treat and prevent hereditary angioedema (HAE) attacks, today provided business updates and company highlights.
  • Pharvaris will conduct a 26-week rodent toxicology study to resolve the clinical holds in the U.S.
  • Based on the Company’s current assumptions regarding ex-U.S. regulatory status and enrollment, Pharvaris anticipates announcing top-line data from the CHAPTER-1 trial in 2H2023.
  • Pharvaris remains diligent in its operational management and is focusing on its existing clinical HAE pipeline to extend runway into 4Q2024.