Ifosfamide

Lipella Pharmaceuticals Announces FDA Type C Meeting for LP-10 for Hemorrhagic Cystitis

Retrieved on: 
Wednesday, April 3, 2024
Urinalysis, Type, HC, Patient, History, Tacrolimus, Urine, Ifosfamide, Nephrology, Breast cancer, Hemorrhagic cystitis, Safety, FDA, Cyclophosphamide, Food, Pharmaceutical industry

Lipella expects to meet with the FDA on May 21, 2024.

Key Points: 
  • Lipella expects to meet with the FDA on May 21, 2024.
  • HC is a serious, life-threatening form of gross hematuria (i.e.
  • Lipella published these results in the peer-reviewed journal, International Urology and Nephrology , in September 2023, and received preliminary guidance from the FDA regarding potential registration endpoints.
  • The company’s anticipated Type C meeting with the FDA will focus on reaching an agreement for the proposed Phase-2b trial design, which Lipella expects to be a 36-subject, prospective, double-blind, placebo-controlled study with a primary efficacy assessment derived from the reduction in patient-reported frequency of gross hematuria episodes over a seven-day period.

CALQUENCE (Acalabrutinib) Emerging Drug Insights and Market Forecasts, 2019-2022 and 2023-2032: Focus on 7MM - United States, Germany, France, Italy, Spain, United Kingdom, and Japan - ResearchAndMarkets.com

Retrieved on: 
Thursday, December 14, 2023
Health, Science, Pharmaceutical, Research, Clinical Trials, Carboplatin, Chemotaxis, Waldenström macroglobulinemia, AstraZeneca, BTK, MCL, Rituximab, B-cell lymphoma, Patient, Ifosfamide, ABC, SWOT, EU4, Etoposide, Follicular lymphoma, Acalabrutinib, Waldenström, RICE, CLL, Axicabtagene ciloleucel, Risk management, Pharmaceutical industry, DLBCL, Phase

The "CALQUENCE Emerging Drug Insight and Market Forecast - 2032" drug pipelines has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "CALQUENCE Emerging Drug Insight and Market Forecast - 2032" drug pipelines has been added to ResearchAndMarkets.com's offering.
  • This report provides comprehensive insights about CALQUENCE for Diffuse Large B-cell lymphoma (DLBCL) in the seven major markets.
  • Further, it also consists of future market assessments inclusive of the CALQUENCE market forecast analysis for DLBCL in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in DLBCL.
  • A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of CALQUENCE in DLBCL.

Rutgers Cancer Institute of New Jersey and RWJBarnabas Health to Showcase Novel and Expansive Hematology/Oncology Data at the 64th American Society of Hematology Annual Meeting and Exposition

Retrieved on: 
Tuesday, November 15, 2022
Lymphoma, 2021 Essex County Council election, National Cancer Institute, Cell therapy, Holism, RICE, DLBCL, Rituximab, Hodgkin lymphoma, Exposition, Lymphatic system, MS, NEW, Rutgers Cancer Institute of New Jersey, Safety, Leukemia, Consortium, Society, Degenerative disease, Carboplatin, Ifosfamide, Transplant, Patient, Robert Wood Johnson Medical School, Etoposide, ASH, NCI-designated Cancer Center, Rutgers University, Multiple myeloma, Diagnosis, RWJBarnabas Health, Pharmaceutical industry, Medicine, MD, Polatuzumab vedotin

NEW BRUNSWICK, N.J., Nov. 15, 2022 /PRNewswire/ -- Physician-scientists from Rutgers Cancer Institute of New Jersey and RWJBarnabas Health will present a wide-ranging scope of new hematology/oncology data from their clinical research program at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition, being held in New Orleans, Louisiana (and virtually) from December 10-13, 2022. A total of 24 abstracts have been accepted, comprising clinical data and analyses that advance the understanding and treatment of such blood cancers as lymphoma, leukemia and myeloma. Rutgers Cancer Institute, together with RWJBarnabas Health, is New Jersey's only National Cancer Institute-designated Comprehensive Cancer Center and the leading cancer program in the state.

Key Points: 
  • A total of 24 abstracts have been accepted, comprising clinical data and analyses that advance the understanding and treatment of such blood cancers as lymphoma, leukemia and myeloma.
  • Rutgers Cancer Institute, together with RWJBarnabas Health, is New Jersey's only National Cancer Institute-designated Comprehensive Cancer Center and the leading cancer program in the state.
  • Pola is an antibody-drug conjugate that is safe and effective when combined with chemotherapy in frontline and relapsed, transplant-ineligible DLBCL patients.
  • The full list of presentations at this year's ASH Annual Meeting and Exposition follows:

PharmaCyte Biotech Board of Directors Announces Business Review Committee to Evaluate Opportunities to Optimize Shareholder Value

Retrieved on: 
Friday, October 7, 2022
U.S. Securities and Exchange Commission, Pancreatic cancer, Assistant, Review, IND, The Co Founder, Neoplasm, Ascites, Lehigh University, LLC, Â, Regulation of tobacco by the U.S. Food and Drug Administration, Cell, Diabetes, Board of directors, Immortalised cell line, Nasdaq, Cancer, Technology, Private Securities Litigation Reform Act, Form 10-K, Food, Company, Share repurchase, Board, CEO, Form, Liver, Ifosfamide, GLOBE, Peritoneal cavity, Insulin, Austria, PMCB, FDA, Capsule, Principal, Management, Pharmaceutical industry, Security (finance), Medical imaging

The Board has since appointed Joshua N. Silverman, a member of the Board, as interim CEO.

Key Points: 
  • The Board has since appointed Joshua N. Silverman, a member of the Board, as interim CEO.
  • Mr. Silverman commented, On behalf of the Board and PharmaCyte shareholders, Id like to wish Ken all the best in his future endeavors.
  • As disclosed in our most recently filed 10-Q, our newly reconstituted Board of Directors has formed a Business Review Committee to evaluate, investigate and review PharmaCytes strategy and operations, as well as the risks relative to our business.
  • Until the review by the Business Review Committee and the Board is complete and the Board has determined the actions and plans to be implemented, the Board has curtailed spending on the foregoing programs.

PharmaCyte Biotech Rebukes Iroquois’ Commencement of Consent Solicitation

Retrieved on: 
Thursday, July 28, 2022
Oncology, Health, Diabetes, Clinical Trials, Pharmaceutical, Biotechnology, Regulation of tobacco by the U.S. Food and Drug Administration, Sale, Acquisition, Knowledge, Diabetes, PMCB, Time, Ascites, Capsule, Food, Industry, U.S. Securities and Exchange Commission, Frustration, SEC, Pancreatic cancer, Neoplasm, Immortalised cell line, Private Securities Litigation Reform Act, Ownership, Peritoneal cavity, Board, NASDAQ, Board of directors, Cancer, Cell, Biotechnology, Liver, Wall Street, Technology, Lifting, FDA, Company, Our Boarding House, Insulin, Form 10-K, Communication, Appendix, Growth, Ifosfamide, Form, Audit, Security (finance), Pharmaceutical industry, Management, Bank, Medical imaging, Iroquois, Nasdaq, IND

We are not responsible for the accuracy of any information provided by or relating to Iroquois contained in any consent solicitation materials filed or disseminated by, or on behalf of, Iroquois or any other statements that Iroquois or its representatives have made or may otherwise make.

Key Points: 
  • We are not responsible for the accuracy of any information provided by or relating to Iroquois contained in any consent solicitation materials filed or disseminated by, or on behalf of, Iroquois or any other statements that Iroquois or its representatives have made or may otherwise make.
  • In fact, the Iroquois consent solicitation is riddled with misstatements.
  • The Iroquois slate is dominated by current or former Iroquois employees, family members of Iroquois management, and individuals who have partnered with Iroquois multiple times in the past resulting in the destruction of shareholder value in numerous documented instances.
  • Please disregard any WHITE consent card that you may receive from Iroquois by taking no action at all.

PharmaCyte Biotech Commences First Phase of Two-Phase Pig Study

Retrieved on: 
Thursday, July 21, 2022
Oncology, Health, Diabetes, Clinical Trials, Pharmaceutical, Biotechnology, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Fluoroscopy, Diabetes, PMCB, Ascites, Necrosis, Capsule, CT, Scar, Tissue, Food, U.S. Securities and Exchange Commission, Pancreatic cancer, Neoplasm, Immortalised cell line, Histology, Private Securities Litigation Reform Act, Pancreas, Health, Peritoneal cavity, Fibrosis, Board, Safety, Thrombosis, Microparticle, NASDAQ, Cancer, Movement, Cell, Clinical trial, Inflammation, Biotechnology, Liver, CT scan, CBSET, Technology, FDA, Board of directors, Human, Serum, Insulin, Form 10-K, Animal, Ifosfamide, Form, IND, Pharmaceutical industry, Medical device, Medical imaging, LAPC

The first phase, which began today, is a short pilot study in two pigs.

Key Points: 
  • The first phase, which began today, is a short pilot study in two pigs.
  • The objective of this pilot study is to assess microcatheter-based delivery of CypCaps in the pancreatic arterial system.
  • Also, the CypCaps used in the study will contain radiopaque microspheres, which will be evaluated to track the movement of the CypCaps.
  • The data obtained from the pilot study will allow us to finalize the full-scale pig study protocol, which will involve 90 pigs.

PharmaCyte Biotech Reports Positive Interim Results in Malignant Ascites Mouse Model Study

Retrieved on: 
Tuesday, July 19, 2022
Software, General Health, Pharmaceutical, Data Management, Oncology, Technology, Health Technology, Public Relations, Investor Relations, Clinical Trials, Biotechnology, Communications, Health, Diabetes, Ascites, Heidelberg, U.S. Securities and Exchange Commission, Peritoneum, Cancer, Patient, Neoplasm, Overalls, Stomach, Cell, Form 10-K, Cell bank, Capsule, Quality of life, Pancreatic cancer, Diabetes, Private Securities Litigation Reform Act, Technology, Mouse, PMCB, Peritoneal cavity, Survival, IND, Board of directors, NASDAQ, Biotechnology, Form, Board, Liver, Ifosfamide, Insulin, Breast, FDA, Immortalised cell line, Abdomen, Pharmaceutical industry, Medical imaging

PharmaCyte Biotech, Inc. (NASDAQ: PMCB), a biotechnology company focused on developing cellular therapies for cancer, diabetes, and malignant ascites using its signature live-cell encapsulation technology, Cell-in-a-Box, announced today that it has achieved positive interim results in its study to establish a malignant ascites mouse model which will form the basis for further testing of the effectiveness of its CypsCaps plus ifosfamide pancreatic cancer therapy for the treatment of malignant ascites.

Key Points: 
  • PharmaCyte Biotech, Inc. (NASDAQ: PMCB), a biotechnology company focused on developing cellular therapies for cancer, diabetes, and malignant ascites using its signature live-cell encapsulation technology, Cell-in-a-Box, announced today that it has achieved positive interim results in its study to establish a malignant ascites mouse model which will form the basis for further testing of the effectiveness of its CypsCaps plus ifosfamide pancreatic cancer therapy for the treatment of malignant ascites.
  • The Sugarbaker-index is a widely used and accepted quantitative prognostic indicator for patients with malignant ascites.
  • PharmaCytes Chief Executive Officer, Kenneth L. Waggoner, said, We are highly encouraged that Heidelberg Pharmas work with this study to establish a malignant ascites mouse model is proceeding exactly as we had hoped and that it has yielded valuable information as we work diligently to advance our therapy for malignant ascites.
  • Malignant ascites is caused by an accumulation of fluid in the peritoneum causing the abdomen to swell as a result of cancer.

PharmaCyte Biotech Announces Preliminary Unaudited Financial Results for Fiscal Year 2022

Retrieved on: 
Monday, July 11, 2022
Biotechnology, Diabetes, Health, Pharmaceutical, Oncology, Private Securities Litigation Reform Act, Clinical trial, Insulin, PMCB, Neoplasm, FDA, Immortalised cell line, Biotechnology, Form 10-K, Hepatology, Diabetes, Pancreatic cancer, Ascites, Liver, Peritoneal cavity, Karolinska Institute, CGMP, IND, Company, Capsule, Cell, U.S. Securities and Exchange Commission, Mission statement, University, Cancer, Technology, Share repurchase, Karolinska University Hospital, Ifosfamide, Patient, Board, Form, NASDAQ, Board of directors, Pharmaceutical industry, Audit, Medical imaging, Gastroenterology, LAPC, Nasdaq

PharmaCyte Biotech, Inc. (NASDAQ: PMCB), a biotechnology company focused on developing cellular therapies for cancer, diabetes and malignant ascites using its signature live-cell encapsulation technology, Cell-in-a-Box, today announced its preliminary unaudited financial results for fiscal year ended April 30, 2022.

Key Points: 
  • PharmaCyte Biotech, Inc. (NASDAQ: PMCB), a biotechnology company focused on developing cellular therapies for cancer, diabetes and malignant ascites using its signature live-cell encapsulation technology, Cell-in-a-Box, today announced its preliminary unaudited financial results for fiscal year ended April 30, 2022.
  • The share repurchase will begin shortly after issuance of our preliminary year-end financial results in this press release.
  • While PharmaCyte expects that its final financial results for its fiscal year and quarter ended April 30, 2022, following the completion of its financial closing procedures, will generally be consistent with the amounts provided in this press release.
  • The results provided in this press release are preliminary and subject to completion and audit of PharmaCytes financial statements.

PharmaCyte Biotech Announces Additional Quality Control Assay and Confirms Stability of CypCap Cells

Retrieved on: 
Tuesday, July 5, 2022
Biotechnology, Pharmaceutical, Health, Oncology, Cell, FDA, Board of directors, Biotechnology, Liver, CGMP, Immortalised cell line, Food and Drug Administration, Capsule, Peritoneal cavity, Cancer, Company, Real-time, U.S. Securities and Exchange Commission, Syringe, Ascites, Ifosfamide, Pancreatic cancer, Form, Diabetes, Food, Drug discovery, Clinical trial, Private Securities Litigation Reform Act, IND, Technology, Neoplasm, PMCB, Quality control, NASDAQ, PCR, Form 10-K, Board, QC, Insulin, Pharmaceutical industry, Dietary supplement, Medical imaging

We are particularly pleased that this independently performed qRT-PCR shows yet again the stability at the genetic level of the cytochrome P450 expressing cells which form the engine for our CypCaps clinical trial product.

Key Points: 
  • We are particularly pleased that this independently performed qRT-PCR shows yet again the stability at the genetic level of the cytochrome P450 expressing cells which form the engine for our CypCaps clinical trial product.
  • The qRT-PCR will thus be used as a quality control (QC) release assay on future cGMP-grade clinical batches of CypCaps.
  • PharmaCytes therapy for cancer involves encapsulating genetically engineered human cells that convert an inactive chemotherapy drug into its active or cancer-killing form.
  • PharmaCytes therapy for malignant ascites involves using the same encapsulated cells PharmaCyte employs for pancreatic cancer but placing the encapsulated cells in the peritoneal cavity of a patient and administering ifosfamide intravenously.

PharmaCyte Biotech Issues Follow-Up Response to Iroquois Capital’s Second Letter on June 9 and Reiterates Commitment to Increasing Shareholder Value

Retrieved on: 
Wednesday, June 15, 2022
Oncology, Health, Diabetes, Clinical Trials, Pharmaceutical, Biotechnology, Well, Time, Diabetes, Review, FDA, Science, Cell, Technology, Achievement, Liver, PMCB, Ascites, Capsule, Ifosfamide, Biotechnology, Cancer, U.S. Securities and Exchange Commission, Research, Goal, Pancreatic cancer, Private Securities Litigation Reform Act, Insulin, Letter, Clinical trial, NASDAQ, IND, Frustration, Our Boarding House, Peritoneal cavity, Board, Board of directors, Neoplasm, Form, Form 10-K, Immortalised cell line, Pharmaceutical industry, Management, Medical imaging, Audit, Iroquois, Nasdaq

However, we find Iroquois decision to continue to publicly issue unfounded statements that misrepresent our actions troubling and potentially detrimental to long-term shareholder value.

Key Points: 
  • However, we find Iroquois decision to continue to publicly issue unfounded statements that misrepresent our actions troubling and potentially detrimental to long-term shareholder value.
  • We believe this accelerated approach will save approximately six months or more of time from what was originally estimated.
  • Our Board, which Iroquois calls dysfunctional, oversaw our successful uplisting to Nasdaq and two capital raises totaling almost $90 million.
  • These goals are consistent with the strategy that we have laid out and continue to reinforce with investors, including Iroquois.