177Lu-Edotreotide (Solucin®) - Ronny Allan - Living with Neuroendocrine Cancer

Tag: 177Lu-Edotreotide (Solucin®)

The compound under investigation, Solucin®, is known as a Targeted Radionuclide Therapy (TRT) agent, which consists of the targeting molecule Edotreotide, an octreotide-derived somatostatin analogue and ITM´s EndolucinBeta® (no-carrier-added Lutetium-177). EndolucinBeta® is a synthetic, low-energy beta-emitting isotope of Lutetium, a recent EMA approved pharmaceutical precursor. The radiopharmaceutical Solucin® is administered as an intravenous infusion, specifically targeting and destroying the tumor cells with ionizing radiation. Solucin® received an Orphan Designation (EMA/OD/196/13) for the treatment of GEP-NET, based on early clinical experience, which has demonstrated a substantial clinical benefit with increased PFS and quality of life. Read more here – click

21Sep 2021 by Ronny Allan No Comments

Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) – (COMPOSE)

Clinical Trials

Garching / Munich, October 27, 2022 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced that the U.S. Food and Drug Administration (FDA) has granted the company Fast Track designation for ITM-11 (n.c.a. 177Lu-edotreotide), an investigational radiopharmaceutical for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). ITM-11 is being evaluated as a Targeted Radionuclide Therapy in two phase III clinical trials, COMPETE and COMPOSE. The FDA Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and address an unmet medical need. The purpose is to bring new and promising medicines to patients sooner. The Fast Track designation enables ITM to have more frequent interactions with the FDA to discuss the ITM-11 development path. It also allows rolling review of the new drug application (NDA)…

18Jun 2020 by Ronny Allan 1 Comment

My interview with ITM – I’m still here!

Awareness, Clinical Trials, Patient Advocacy

Share on facebook Facebook Share on twitter Twitter Share on pinterest Pinterest Share on whatsapp WhatsApp Share on email Email I was delighted to be contacted by ITM AG, a Germany based pharmaceutical company specialising in targeted radionuclide technology in precision oncology (e.g. Peptide Receptor Radionuclide Therapy - PRRT). The company is formally known as ITM Isotopen Technologien München.One of their pipeline developments is 177Lu-Edotreotide / Solucin® in patients with neuroendocrine tumors of gastroenteric or pancreatic origin (GEP-NET). The development is via the COMPETE Phase III Clinical Trial which is being conducted worldwide in 11 countries at 33 sites and is open for recruitment. I actually wrote about this trial after attending a workshop at the annual ENETS conference in 2018.I was delighted when they wanted to interview me to…

30Aug 2018 by Ronny Allan 2 Comments

Detectnet™ (64Cu-DOTATATE) – an expansion of the Somatostatin Receptor PET Imaging for Neuroendocrine Cancer

Clinical Trials, Living with Neuroendocrine Cancer, Treatment

Edit 21st January 2021. The imaging time window of 64Cu-DOTATATE positron emission tomography/computed tomography (PET/CT) for patients with neuroendocrine neoplasms can be expanded from one hour to three hours post-injection, according to new research published in the January 2021 issue of The Journal of Nuclear Medicine. Read more here Edit 4th September 2020. 64Cu-dotatate now named Detectnet™ is approved for use by US FDA. Majority read revealed Detectnet had over 98% accuracy, 100% sensitivity, and over 96% specificity to confirm or exclude presence of disease. Read more here. Edit 14th July 2020. Expanded Access Program via clinical trial now recruiting - see below. The objective of this trial is to provide patients with confirmed or suspicion of NET access to Copper Cu 64 Dotatate for the detection, localization, and monitoring of…

08May 2017 by Ronny Allan 45 Comments

All you need to know about Peptide Receptor Radionuclide Therapy (PRRT)

Clinical Trials, Treatment

Update June 6th 2021. Novartis reports clinically relevant improvement in median overall survival data in final analysis of pivotal NETTER-1 study with targeted radioligand therapy Lutathera. New analysis of the NETTER-1 trial data has been published. For those who just need a quick summary, the quote from Dr Jonothan Strosberg is below. Short PRRT PrimerWhat is Peptide Receptor Radionuclide Therapy (PRRT)?For those who are still not sure what it's all about. This is a non-surgical treatment which is normally administered intravenously. It's based on the use of somatostatin receptors to attract a 'radiopeptide'. The radiopeptide is a combination of a somatostatin analogue and a radioactive material. As we already know, somatostatin analogues (i.e. Lanreotide/Octreotide) are a NET cell targeting drug using somatostatin receptors, so when combined with radioactivity, it binds with…