Topotecan

Panbela Provides Business Update and Reports Q4 and FY 2024 Financial Results

Retrieved on: 
Tuesday, March 26, 2024
Research, Topotecan, PBLA, Neuroblastoma, Patient, Data monitoring committee, Acquisition, Celecoxib, Doctor of Philosophy, AACR, MSN, CPP, Pancreatic cancer, Therapy, DSMB, Poster, DFMO, Cyclophosphamide, Pharmaceutical industry

MINNEAPOLIS, March 26, 2024 (GLOBE NEWSWIRE) -- Panbela Therapeutics, Inc. (NASDAQ:PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, today provides a business update and reports financial results for the quarter and full year ended December 31, 2023.

Key Points: 
  • MINNEAPOLIS, March 26, 2024 (GLOBE NEWSWIRE) -- Panbela Therapeutics, Inc. (NASDAQ:PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, today provides a business update and reports financial results for the quarter and full year ended December 31, 2023.
  • “Looking ahead, Panbela remains unwavering in its commitment to patients and in its pursuit of maximizing value for stockholders.
  • Notes payable, plus accrued interest, on the balance sheet, the result of the acquisition of CPP, totaled approximately $5.4 million.
  • Gross proceeds from the raise, which closed on January 31, 2024, were approximately $9 million.

Salarius Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Friday, March 22, 2024
Research, Topotecan, TC, LSD1, Survival, Bone marrow, Progression-free survival, DCR, Patient, Acquisition, Deuterium, NHL, IND, Myelodysplastic syndrome, Non-Hodgkin lymphoma, Clinical trial, Azacitidine, Chronic myelomonocytic leukemia, Probability, Cyclophosphamide, FDA, MD Anderson Cancer Center, Ewing sarcoma, Consultant, Food, Pharmaceutical industry

HOUSTON, March 22, 2024 (GLOBE NEWSWIRE) -- Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage biopharmaceutical company using protein inhibition and protein degradation to develop cancer therapies for patients in need of new treatment options, today reported financial results for the three and 12 months ended December 31, 2023 and provided a business update.

Key Points: 
  • Cash and cash equivalents were $5.9 million as of December 31, 2023, compared with $12.1 million as of December 31, 2022.
  • In August 2023 Salarius announced a comprehensive review of strategic alternatives focused on maximizing shareholder value.
  • Research and development expenses were $0.06 million for the fourth quarter of 2023, compared with $4.7 million for the fourth quarter of 2022, reflecting the above-mentioned cost-savings plan.
  • Net cash used for operating activities during the fourth quarter of 2023 was $1.5 million, compared with $4.7 million during the same quarter in 2022, reflecting the above-mentioned cost-savings plan.

Verastem Oncology Announces Initiation of a Confirmatory Phase 3 Trial of Avutometinib and Defactinib in Recurrent Low-Grade Serous Ovarian Cancer

Retrieved on: 
Wednesday, December 13, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, NDA, Paclitaxel, Woman, Institute of Cancer Research, Research, Safety, Food, Avutometinib, Cancer, Letrozole, Disease, Verastem Oncology, Patient, Anastrozole, GOG, PFS, Consultant, RAMP, Breakthrough therapy, Part, FDA, NHS foundation trust, FRAME, ORR, The Institute, Ovarian cancer, FRCP, Doctor of Philosophy, Physician, Accelerated approval (FDA), Royal Marsden Hospital, Pharmaceutical industry, MBBS, Topotecan

“Patients and treating physicians have advocated for more research and development in support of LGSOC.

Key Points: 
  • “Patients and treating physicians have advocated for more research and development in support of LGSOC.
  • At Verastem Oncology, we are moving with urgency to offer a Phase 3 study specifically directed at this disease in an effort to address this need,” said Dan Paterson, President and Chief Executive Officer, Verastem Oncology.
  • RAMP 301 is a global trial with enrollment open in the U.S. and planned enrollment in Canada, the United Kingdom, Europe, Australia, and Korea.
  • Dr. Grisham and Dr. Banerjee are paid consultants for Verastem Oncology.

Verastem Oncology Reports Third Quarter 2023 Financial Results and Highlights Recent Company Progress

Retrieved on: 
Wednesday, November 8, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Standard of care, NSCLC, Food, Pancreas, Anastrozole, Regulatory affairs, Ovarian cancer, GAAP, Pancreatic Cancer Action Network, Paclitaxel, Accelerated approval (FDA), ORR, European Network of Transmission System Operators for Electricity, Safety, Cancer, Therapy, Investment, Patient, General Administration of Sport of China, Verastem Oncology, Topotecan, Conference, Bank statement, Clinical trial, FRAME, Travel, Letrozole, RAMP, FDA, SOC, AACR, RAS, Research and development, The Annual Global Orgasm for Peace, GOG, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, KRAS, Senior, Pharmacokinetics, European Society of Gynaecological Oncology, Lung cancer, Table, Diagnosis, Pharmaceutical industry, Bank, Finance

Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today reported financial results for the third quarter ending September 30, 2023 and highlighted recent progress.

Key Points: 
  • Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today reported financial results for the third quarter ending September 30, 2023 and highlighted recent progress.
  • Verastem Oncology ended the third quarter of 2023 with cash, cash equivalents and investments of $165.7 million.
  • Research & development expenses for the 2023 Quarter were $13.9 million, compared to $11.3 million for the 2022 Quarter.
  • Selling, general & administrative expenses for the 2023 Quarter were $7.4 million, compared to $6.4 million for the 2022 Quarter.

Salarius Completes FDA Type B Meeting for Seclidemstat Ewing Sarcoma Development Program

Retrieved on: 
Tuesday, November 7, 2023
Survival, FDA, Trial of the century, TC, Salinicola salarius, Cyclophosphamide, Hematological Cancer Research Investment and Education Act, Food, Progression-free survival, DCR, Canaccord Genuity, Disclosure, Acquisition, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Ewing sarcoma, Clinical trial, Cancer, ORR, LSD1, MD Anderson Cancer Center, Patient, Pharmaceutical industry, Topotecan

HOUSTON, Nov. 07, 2023 (GLOBE NEWSWIRE) -- Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX) announces that it participated in a Type B End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) to receive guidance regarding the development program for seclidemstat to treat Ewing sarcoma. The Company has received the final meeting minutes and is amending the current clinical trial protocol to reflect guidance agreed to with FDA during the EOP2 meeting.

Key Points: 
  • FDA briefing included new Ewing sarcoma clinical data from ongoing investigation where 60% of first-relapse patients achieved disease control and have not progressed after at least 14.5, 19.7 and 22.8 months
    Future development activities were identified; Salarius intends to submit an amended Ewing sarcoma clinical trial protocol
    HOUSTON, Nov. 07, 2023 (GLOBE NEWSWIRE) -- Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX) announces that it participated in a Type B End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) to receive guidance regarding the development program for seclidemstat to treat Ewing sarcoma.
  • The Company has received the final meeting minutes and is amending the current clinical trial protocol to reflect guidance agreed to with FDA during the EOP2 meeting.
  • Salarius is currently evaluating strategic options to advance the clinical development of seclidemstat with a third party.
  • The Company-sponsored Ewing sarcoma clinical trial focuses on seclidemstat in combination with topotecan and cyclophosphamide (TC) chemotherapy as a treatment for relapsed and refractory Ewing sarcoma.

Theriva™ Biologics and Sant Joan de Déu-Barcelona Children’s Hospital Advance Strategic Collaboration to Explore the Combination of VCN-01 with Topoisomerase Inhibitors to Treat Cancer

Retrieved on: 
Thursday, November 2, 2023
Neoplasm, Child, Neuroblastoma, Adolescence, Topotecan, NYSE, Cancer, Therapy, Lung, Ewing sarcoma, Partnership, Sant Joan, SJD, Pharmaceutical industry

ROCKVILLE, Md. and BARCELONA, Spain, Nov. 02, 2023 (GLOBE NEWSWIRE) -- Theriva™ Biologics (NYSE American: TOVX), (“Theriva” or the “Company”), a clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, and Sant Joan de Déu-Barcelona Children’s Hospital (“SJD”), a university hospital specializing in maternal, child and adolescent health care, today announced that Theriva has executed an exclusive worldwide option to negotiate an exclusive license certain SJD intellectual property rights related to the use of VCN-01 in combination with topoisomerase I inhibitor chemotherapies for the treatment of cancer. VCN-01 is Theriva’s systemic, selective, stroma-degrading oncolytic adenovirus.

Key Points: 
  • The collaboration builds on growing data that suggests coadministration of VCN-01 with topoisomerase I inhibitors such as topotecan can enhance VCN-01 replication and antitumor activity in preclinical cancer models.
  • “Topoisomerase I inhibitors are used to treat a range of challenging tumors, including lung, cervical, colorectal, and pancreatic cancers as well as retinoblastoma.
  • Recent findings suggest that the combination of VCN-01 and topoisomerase I inhibitors may provide a synergistic antitumor effect to improve therapeutic outcomes in these indications.
  • Synergy happens through the effect of topotecan increasing the susceptibility of cancer cells to VCN-01 infection.

Verastem Oncology Announces Efficacy and Safety Data of Avutometinib and Defactinib in Recurrent Low-Grade Serous Ovarian Cancer (LGSOC) in Heavily Pretreated Patient Population

Retrieved on: 
Monday, November 6, 2023
Research, General Health, Pharmaceutical, Oncology, Consumer, Clinical Trials, Science, Women, Biotechnology, FDA, Other Science, Health, Ovarian cancer, RAMP, Standard of care, SOC, Topotecan, Food, Lot, Soda Springs, The Annual Global Orgasm for Peace, Safety, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Society, Paclitaxel, Disease, Memorial Sloan Kettering Cancer Center, FRAME, ORR, Letrozole, RECIST, Part, Cancer, Patient, Anastrozole, Verastem Oncology, Pharmaceutical industry

Verastem Oncology (Nasdaq: VSTM) (the “Company”), a biopharmaceutical company committed to advancing new medicines for patients with cancer, announced today results of the efficacy and safety of avutometinib and defactinib in recurrent low-grade serous ovarian cancer (LGSOC) following prior systemic therapy.

Key Points: 
  • Verastem Oncology (Nasdaq: VSTM) (the “Company”), a biopharmaceutical company committed to advancing new medicines for patients with cancer, announced today results of the efficacy and safety of avutometinib and defactinib in recurrent low-grade serous ovarian cancer (LGSOC) following prior systemic therapy.
  • The analysis also evaluated efficacy in the context of best response to most recent prior treatment in the metastatic/recurrent setting.
  • The safety profiles of avutometinib and defactinib were similar in the less and more heavily pretreated subgroups and both analyses were consistent with previously reported safety data.
  • Dr. Grisham is a paid consultant for Verastem Oncology.

ELAHERE® Shows Overall and Progression-Free Survival Benefit Regardless of Prior PARPi Exposure or Prior Lines of Therapy in FRα-Positive Platinum-Resistant Ovarian Cancer

Retrieved on: 
Thursday, September 28, 2023
Oncology, Health, General Health, Research, Science, Pharmaceutical, Biotechnology, Topotecan, European Society of Gynaecological Oncology, Pros, Bevacizumab, University, Progression-free survival, Neoplasm, Catholic University of Leuven (1834–1968), OS, IC, Cancer, Paclitaxel, PLD, ESGO, PFS, University Clinical Centre in Gdańsk, Mirvetuximab soravtansine, IMGN, PROC, ASCO, Congress, Ventana, American Society of Clinical Oncology, Patient, Physician, TYPE, Annual general meeting, CRS, Spacecraft, GOG, PARP, Society, ORR, Safety, Pharmaceutical industry, Medical imaging

Patients were stratified by number of prior lines of therapy (14% had one prior line of therapy, 40% had two prior lines of therapy, and 46% had three prior lines of therapy) and by IC chemotherapy, with paclitaxel as the most commonly chosen (41%), followed by PLD (36%) and topotecan (23%).

Key Points: 
  • Patients were stratified by number of prior lines of therapy (14% had one prior line of therapy, 40% had two prior lines of therapy, and 46% had three prior lines of therapy) and by IC chemotherapy, with paclitaxel as the most commonly chosen (41%), followed by PLD (36%) and topotecan (23%).
  • 62% of patients received prior bevacizumab; 55% received a prior PARP inhibitor.
  • Key secondary endpoints include objective response rate (ORR), overall survival (OS), and patient-reported outcomes (PROs).
  • ELAHERE demonstrated clinically meaningful improvements in PFS and ORR by investigator assessment and in OS compared to IC chemotherapy, regardless of prior lines of therapy (PLOT).

Verastem Oncology Reports Second Quarter 2023 Financial Results and Highlights Recent Company Progress

Retrieved on: 
Tuesday, August 8, 2023
Research, FDA, Clinical Trials, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, Other Science, Topotecan, Pancreatic cancer, KRAS, Verastem Oncology, Avutometinib, Table, BIW, Pancreatic Cancer Action Network, Bank statement, General Administration of Press and Publication, Pancreas, Cancer, Paclitaxel, Anastrozole, GAAP, SOC, NSCLC, FRAME, Lung cancer, PFS, RAMP, Acquisition, HIV disease progression rates, RAS, Patient, Standard of care, Investment, European Society of Gynaecological Oncology, GOG, European Network of Transmission System Operators for Electricity, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Research and development, Society, Breakthrough, ORR, Letrozole, Food, Safety, Pharmaceutical industry, Transformer

Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today reported financial results for the second quarter ending June 30, 2023 and highlighted recent progress.

Key Points: 
  • Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today reported financial results for the second quarter ending June 30, 2023 and highlighted recent progress.
  • Verastem Oncology ended the second quarter of 2023 with cash, cash equivalents and investments of $183.1 million.
  • Research & development expenses for the 2023 Quarter were $12.9 million, compared to $14.9 million for the 2022 Quarter.
  • Selling, general & administrative expenses for the 2023 Quarter were $7.4 million, compared to $6.5 million for the 2022 Quarter.

Merrimack Reports Second Quarter 2023 Financial Results

Retrieved on: 
Thursday, August 3, 2023
Research, FDA, Clinical Trials, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, Other Science, Topotecan, Carcinoma, NAPOLI, Progression-free survival, Oxaliplatin, Overalls, Survival, Clinical trial, Elevation, PFS, Trial of the century, Medication, ASCO, Shanda, American Society of Clinical Oncology, Investment, Patient, Phase, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Society, Merrimack, Food, Seribantumab, Safety, Pharmaceutical industry, Medical imaging, Ipsen, Irinotecan

Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) [(“Merrimack” or the “Company”)] today announced its second quarter 2023 financial results for the period ended June 30, 2023.

Key Points: 
  • Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) [(“Merrimack” or the “Company”)] today announced its second quarter 2023 financial results for the period ended June 30, 2023.
  • Interest income in the second quarter ended June 30, 2023, was $178 thousand compared to $8 thousand for the same period in 2022.
  • General and administrative expenses for the second quarter ended June 30, 2023, were $569 thousand, compared to $486 thousand for the same period in 2022.
  • In January 2023, Ipsen presented clinical trial results at the 2023 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium.