Macrocycles

Excel Diagnostics and Nuclear Oncology Center Announces FDA Authorization of IND for 225Ac-PSMA I&T Targeted Alpha Therapy for Castration Resistant Prostate Cancer

Retrieved on: 
Wednesday, August 4, 2021

Houston, TX, Aug. 04, 2021 (GLOBE NEWSWIRE) -- Excel Diagnostics and Nuclear Oncology Center (EDNOC), a premier Diagnostic Imaging and Radioligand Therapy center in Houston, Texas announces approval of its physicians sponsored Investigational New Drug (IND) application for providing Targeted Alpha Therapy (TAT) with 225Ac-PSMA I&T for metastatic Castration-Resistant Prostate Cancer (mCRPC).

Key Points: 
  • Houston, TX, Aug. 04, 2021 (GLOBE NEWSWIRE) -- Excel Diagnostics and Nuclear Oncology Center (EDNOC), a premier Diagnostic Imaging and Radioligand Therapy center in Houston, Texas announces approval of its physicians sponsored Investigational New Drug (IND) application for providing Targeted Alpha Therapy (TAT) with 225Ac-PSMA I&T for metastatic Castration-Resistant Prostate Cancer (mCRPC).
  • Excel Diagnostics and Nuclear Oncology Center has been a pioneer in bringing new targeted Radioligand Therapies such as Lu-177 DOTATATE, and Lu-177 PSMA to serve our patients in the United States.
  • Highly encouraging results have been reported by using Targeted Alpha Therapy (TAT) Radiopharmaceuticals in conditions such as neuroendocrine, prostate, or hematological malignancies.
  • In April of 2020, Excel passed FDA inspection of one of its investigational drugs with no deficiencies or citations.

Polyphor to Present at the UBS Global Healthcare Virtual Conference

Retrieved on: 
Tuesday, May 18, 2021

Polyphor is advancing balixafortide (POL6326) in a Phase III trial in combination with eribulin in patients with advanced breast cancer and exploring its potential in other cancer indications.

Key Points: 
  • Polyphor is advancing balixafortide (POL6326) in a Phase III trial in combination with eribulin in patients with advanced breast cancer and exploring its potential in other cancer indications.
  • In addition, it has discovered and is developing the Outer Membrane Protein Targeting Antibiotics (OMPTA).
  • OMPTA are potentially the first new class of antibiotics in clinical development in the last 50 years against Gram-negative bacteria.
  • Polyphor is based in Allschwil near Basel and is listed on the SIX Swiss Exchange (SIX: POLN).

RayzeBio Appoints Yi Larson to Its Board of Directors and Expands Team with Key Leadership Hires

Retrieved on: 
Wednesday, April 21, 2021

b'RayzeBio, Inc., a targeted radiopharmaceutical company developing an innovative pipeline against validated solid tumor targets, appointed Yi Larson to its board of directors effective April 1, 2021.

Key Points: 
  • b'RayzeBio, Inc., a targeted radiopharmaceutical company developing an innovative pipeline against validated solid tumor targets, appointed Yi Larson to its board of directors effective April 1, 2021.
  • \xe2\x80\x9cThe company has impressively built an infrastructure to drive innovation in the sector.
  • Prior to joining RayzeBio, Dan was the head of radiopharmaceutical manufacturing at Novartis/AAA for Lutathera\xc2\xae, an approved targeted radiotherapy drug.
  • \xe2\x80\x9cDerek and Dan have been working with RayzeBio since earlier this year and have contributed to tangible progress in our discovery and development efforts.

RadioMedix & Curium Announce Simplified Coding for DetectnetTM (copper Cu 64 dotatate injection)

Retrieved on: 
Tuesday, March 23, 2021

Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure.

Key Points: 
  • Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure.
  • The uptake of copper Cu 64 dotatate reflects the level of somatostatin receptor density in NETs, however, uptake can also be seen in a variety of other tumors that also express somatostatin receptors.
  • A negative scan after the administration of Detectnet in patients who do not have a history of NET disease does not rule out disease.
  • Non-radioactive somatostatin analogs and copper Cu 64 dotatate competitively bind to somatostatin receptors (SSTR2).

RadioMedix & Curium Announce Permanent HCPCS Code for DetectnetTM (copper Cu 64 dotatate injection)

Retrieved on: 
Tuesday, January 26, 2021

Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure.

Key Points: 
  • Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure.
  • The uptake of copper Cu 64 dotatate reflects the level of somatostatin receptor density in NETs, however, uptake can also be seen in a variety of other tumors that also express somatostatin receptors.
  • A negative scan after the administration of Detectnet in patients who do not have a history of NET disease does not rule out disease.
  • Non-radioactive somatostatin analogs and copper Cu 64 dotatate competitively bind to somatostatin receptors (SSTR2).

POINT Biopharma Signs Exclusive License Agreement with CanProbe for the Commercialization of a Neuroendocrine Tumor Treatment

Retrieved on: 
Tuesday, January 12, 2021

CanProbes NET clinical program has helped many patients in Ontario who previously had no other options for treatment, says Dr. Joe McCann, Chief Executive Officer of POINT Biopharma.

Key Points: 
  • CanProbes NET clinical program has helped many patients in Ontario who previously had no other options for treatment, says Dr. Joe McCann, Chief Executive Officer of POINT Biopharma.
  • We are looking forward to working with POINT Biopharma on the commercialization of Lu-DOTATATE, says Dr. Luke Brzozowski, President of CanProbe.
  • We believe POINT is the ideal partner to make this treatment accessible to patients in Ontario and across the globe.
  • POINT Biopharma is a globally focused radiopharmaceutical company building a platform for the clinical development and commercialization of radioligands that fight cancer.

Cyclolab and EpiPharma Form Joint Venture company Targetrin Therapeutics to Develop and Commercialize novel conjugated Cyclodextrin – Peptide drugs

Retrieved on: 
Monday, January 11, 2021

According to the agreement, the new joint venture will be named Targetrin Therapeutics LLC (Targetrin).

Key Points: 
  • According to the agreement, the new joint venture will be named Targetrin Therapeutics LLC (Targetrin).
  • Targetrin will develop novel drug candidates through the unique combination of industry leading novel cyclodextrin R&D and cGMP manufacturing capabilities of Cyclolab and EpiPharmas proteomimetic peptide chemistry platform.
  • "We are delighted to be working with EpiPharma, a unique company with state-of-the-art proteomimetic peptide chemistry science and comprehensive disease model diagnostic capabilities.
  • With the unique and wide-spread expertise in cyclodextrin science, Cyclolab simultaneously acts as a commercial excipient manufacturer, service provider, fine chemical supplier and a pharmaceutical company.

Polyphor Announces Third Positive Data Safety Monitoring Board (DSMB) Recommendation to Continue Phase III balixafortide FORTRESS Study Without Modifications

Retrieved on: 
Monday, December 14, 2020

The DSMB indicated that the Phase III clinical study should continue without modifications.

Key Points: 
  • The DSMB indicated that the Phase III clinical study should continue without modifications.
  • "We are pleased with the DSMB recommendation that the Phase III clinical trial continues without any protocol modification," said Frank Weber, MD, CMDO of Polyphor.
  • FORTRESS (POL6326-009) is an international, multicenter, randomized active-controlled, open-label Phase III trial which will investigate the efficacy, safety and tolerability of intravenous balixafortide given with eribulin versus eribulin alone in the treatment of HER2 negative, locally recurrent or metastatic breast cancer.
  • For more information about the POL6326-009 clinical trial of balixafortide, please visit www.clinicaltrials.gov (Identifier: NCT03786094).

RadioMedix & Curium Announce CMS Transitional Pass-Through Status for Detectnet™ (copper Cu 64 dotatate injection)

Retrieved on: 
Wednesday, December 9, 2020

The response to Detectnet in the neuroendocrine community has been tremendous, said Curium CEO, North America, Dan Brague.

Key Points: 
  • The response to Detectnet in the neuroendocrine community has been tremendous, said Curium CEO, North America, Dan Brague.
  • The recent inclusion in a major Appropriate Use Criteria confirms the clinical utility of Detectnet in the neuroendocrine community, said Ebrahim Delpassand, MD, CEO of RadioMedix.
  • Detectnet is indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult patients.
  • Non-radioactive somatostatin analogs and copper Cu 64 dotatate competitively bind to somatostatin receptors (SSTR2).

Eisai to Present Abstracts on Oncology Products and Pipeline at 43rd Annual San Antonio Breast Cancer Symposium

Retrieved on: 
Friday, December 4, 2020

The results of analysis evaluating eribulin in the clinical practice in a subgroup of patients with metastatic breast cancer with a poor prognosis, in the United States, (Abstract No: PS13-37) will be published.

Key Points: 
  • The results of analysis evaluating eribulin in the clinical practice in a subgroup of patients with metastatic breast cancer with a poor prognosis, in the United States, (Abstract No: PS13-37) will be published.
  • In March 2018, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A., through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvatinib.
  • Eisai positions oncology as a key therapeutic area, and is aiming to discover revolutionary new medicines with the potential to cure cancer.
  • There is no guarantee that any investigational compounds or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.