Genome methylation accurately predicts neuroendocrine tumor origin – finding Neuroendocrine Neoplasms of unknown primary

Genome methylation accurately predicts neuroendocrine tumor origin – finding Neuroendocrine Neoplasms of unknown primary

Clinical Trials, Patient Advocacy
It's estimated that around 5-10% of Neuroendocrine Neoplasms (NENs) have an unknown primary - what that means is cancer cells have been found in the body but the place cancer began remains unknown.  I wrote about this issue in more depth in my article "Needle in a haystack" - you can read that here.  In that article, you will note that NET specialists through their knowledge and understanding of the behaviour of these comped tumours, can often drill down and gather various pieces of evidence to help narrow down the primary location. However, this new study would indicate they could have access to a new tool to be able to home in on a particular location.DNA methylation-based profiling is now routinely used in the diagnostic workup of brain tumors but…
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Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine Tumors – PRRT vs Everolimus

Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine Tumors – PRRT vs Everolimus

Clinical Trials
When I see a trial for Gastroenteropancreatic NETs (GEPNETs), I know that BP (Bronchopulmonary) NETs (includes Lung) are not included.  When you look at the approval wording for the major treatments in use (PRRT Lutathera, Lanreotide), they appear to use the term GEPNETs making BP NETs the poor relative.  Clearly there's highly complex reasons why NETs react differently in different parts of the body.  I can see that BP NET patients were involved in clinical trials for both of the mainstream treatments listed above.  The drug approval process is also highly complex, and I can see from the wording that functional BP NETs with carcinoid syndrome can qualify at least for somatostatin analogues (Lanreotide and Octreotide).  That is not to say BP NET patients cannot get access to these treatments,…
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Selecting patients and the Challenges of Evaluating Response to PRRT in GEPNETs: The Present and the Future

Selecting patients and the Challenges of Evaluating Response to PRRT in GEPNETs: The Present and the Future

Clinical Trials, Patient Advocacy, Treatment
Share on facebook Facebook Share on twitter Twitter Share on pinterest Pinterest Share on whatsapp WhatsApp Share on email Email Fascinating article from the Italian NET scientific community.  This article is more than just what the title says, it provides overviews on many facets of NETs including markers, scans and PRRT itself. It covers how to select patients for PRRT in the first place, i.e. who is most likely to get a good response to this treatment and then look at how to track and assess that response. The important thing I gathered from reading is that none of this is a precise science, there are too many variables.  And while this article focusses on the clinical factors, there can of course be non-clinical factors in play in different countries…
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Clinical Trial: Phase II CLARINET FORTE Somatuline Autogel (Lanreotide) increased dosing frequency

Clinical Trial: Phase II CLARINET FORTE Somatuline Autogel (Lanreotide) increased dosing frequency

Clinical Trials, Treatment
CLARINET FORTE is a prospective single-arm, open-label, exploratory, international Phase II study to explore the efficacy and safety of an increased Somatuline® Autogel® (lanreotide) dosing frequency (120 mg every 14 days) in patients with metastatic or locally advanced unresectable pancreatic NETs or midgut NETs, with centrally-accessed progression within the last two years while on a standard lanreotide regimen (120 mg every 28 days) for more than 24 weeks.Data announced in September 2020 at the 2020 European Society for Medical Oncology (ESMO), indicated the phase 2 results support a clinically meaningful benefit to a population of patients with high unmet medical need by potentially delaying escalation to more toxic treatments. This means patients with progressive NETs are able to remain on a more tolerable first-line standard of care for longer,” said Professor…
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Clinical Trial of Tidutamab in Neuroendocrine Cancer (DUET-1)

Clinical Trial of Tidutamab in Neuroendocrine Cancer (DUET-1)

Clinical Trials
UPDATE:  13th July 2022Xencor halted this clinical trial due to disappointing results.  Click here to read moreXencor, a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of cancer and autoimmune diseases, today announced that initial data from its ongoing Phase 1 dose-escalation study of tidutamab (XmAb®18087), an SSTR2 x CD3 bispecific antibody, in patients with neuroendocrine tumors (NETs) will be presented during the upcoming North American Neuroendocrine Tumor Society’s 2021 Multidisciplinary NET Medical Virtual Symposium (note - it was also presented at NANETS 2020). What are monocloncal antibodies?  See here About Tidutamab Monoclonal antibodies are laboratory-produced molecules engineered to serve as substitute antibodies that can restore, enhance or mimic the immune system's attack on cancer cells. They are designed to bind to antigens that are generally more numerous on…
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The NETest® – a Chromogranin A replacement and more?

The NETest® – a Chromogranin A replacement and more?

A Spotlight on NENs - Testing Series, Clinical Trials, Patient Advocacy
Tumour Markers General For some years the gold standard tumour marker for Neuroendocrine Neoplasms (NENs) has been and remains today, Chromogranin A (and for certain scenarios Chromogranin B and C can provide some additional clues).  Pancreastatin, which is actually a molecule of Chromogranin A, is another marker touted but appears to be limited to USA. Its main advantage is the ability to better handle the effects of Proton Pump Inhibitor (PPI) use which is prevalent in the general population.  As we move to a new era of molecular/genetic tumour markers, there's a danger that NENs will be left behind, stuck with diagnostic tools not capable of meeting new demands. I see a lot of public criticism of Chromogranin A, but it's mainly directed at the problem of being skewed by…
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SSTR PET – Ga68-DOTA-JR11 vs Ga68-DOTATATE

SSTR PET – Ga68-DOTA-JR11 vs Ga68-DOTATATE

Clinical Trials
Share on facebook Facebook Share on twitter Twitter Share on pinterest Pinterest Share on whatsapp WhatsApp Share on email Email Headline - 68Ga-DOTA-JR11 was found to detect significantly more liver lesions than 68Ga-DOTATATE; however, 68Ga-DOTATATE detected more bone lesions than 68Ga-DOTA-JR11.Although it had been in trial use for some years in Europe and elsewhere, the formal approval of 68Ga-DOTATATE has led to an increase in the development of other radionuclides, some in conjunction with therapeutic options (i.e. PRRT) making a 'theranostic' approach to diagnosing, treating and surveillance Neuroendocrine Cancer patients with somatostatin receptor positive tumours.  I also wrote last year about another option called 64Cu, something already available in Europe, in particular Denmark.In another development which has been running for some time, a Ga68 variant called 68Ga-DOTA-JR11 has been in trial…
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Targeted Therapy for Neuroendocrine Cancer – Sunitinib (Sutent)

Targeted Therapy for Neuroendocrine Cancer – Sunitinib (Sutent)

Clinical Trials, Treatment
Click here to see the A to Z of Neuroendocrine Cancer What is Sunitinib (Sutent)? Manufactured by Pfizer, this is a targeted biological therapy or more accurately, a multitargeted tyrosine kinase inhibitor (TKI).  You may also see it described as an anti-angiogenic agent on the basis that these tumor types are highly vascularized and show high expression of something called vascular endothelial growth factor (VEGF), a key driver of angiogenesis in neuroendocrine tumors. Because NETs are generally hypervascularized tumors, treatment with antiangiogenic drugs seems a rational approach. A complex process but in the simplest of terms, sunitinib blocks a particular enzyme and keeps tumors from making their own blood vessels, which are needed to deliver oxygen and other nutrients to help them survive and grow. In clinical trials, SUTENT was…
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Targeted Therapy for Neuroendocrine Cancer – Everolimus (Afinitor)

Targeted Therapy for Neuroendocrine Cancer – Everolimus (Afinitor)

Clinical Trials, Treatment
Click picture to read the A to Z of Neuroendocrine Cancer What is Everolimus (Afinitor)? Manufactured by Novartis, this is a targeted biological therapy or more accurately, a mammalian Target of Rapamycin (mTOR) inhibitor. It works by stopping some of the signals within cells that make them grow and divide. Everolimus stops a particular protein called mTOR from working properly. mTOR controls other proteins that trigger cancer cells to grow. So everolimus helps to stop the cancer growing or may slow it down.  The drug is also approved for Renal Cell Carcinoma (RCC) and hormone-receptor-positive advanced Breast Cancer.The drug is administered in oral form (tablet). The recommended dose for AFINITOR® (everolimus) Tablets is one 10-mg tablet once daily but lower doses of 7.5-mg tablets, 5-mg tablets, and 2.5-mg tablets are…
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My interview with ITM – I’m still here!

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…
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Clinical Trial:  Lu-177 DOTATOC (PRRT) in adult subjects with Somatostatin receptor (SSTR) positive Pulmonary, Pheochromocytoma, Paraganglioma,  Unknown primary, and Thymic Neuroendocrine Tumors

Clinical Trial: Lu-177 DOTATOC (PRRT) in adult subjects with Somatostatin receptor (SSTR) positive Pulmonary, Pheochromocytoma, Paraganglioma,  Unknown primary, and Thymic Neuroendocrine Tumors

Clinical Trials
Excellent news for those who don't have Gastroenteropancreatic NETs (GEP-NETs). A trial of PRRT is being set-up for the less common types of NET including those with an unknown primary.  Using the DOTATOC radionuclide rather than the Lutathera model of using DOTATATE, this trial will cater for Pulmonary, Pheochromoctyoma, Paraganlioma, Unknown Primary and Thymic Neuroendocrine Tumours.Excel Diagnostics and Nuclear Oncology Center (EDNOC) announced today that its physician sponsored Investigational New Drug (IND) application to evaluate safety and efficacy of Lu-177 DOTATOC in adult subjects with Somatostatin receptor (SSTR)  expressing Pulmonary, Pheochromocytoma, Paraganglioma, Unknown primary, and Thymic Neuroendocrine Tumors (PUT-NET),  has received approval to proceed by USA Food and Drug Administration (FDA) and also charge authorization has been granted (IND#143631, NCT04276597). This IND is anticipated to start enrolling patients by early…
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Oral Octreotide using RaniPill™

Oral Octreotide using RaniPill™

Clinical Trials
Credit: Rani Therapeutics Update 21st March 2022 Preclinical data demonstrates new RaniPill™ HC (High Capacity) delivered 500%-plus higher payloads than current RaniPill™ capsule. Up to 20mg payload has the potential to unlock more than 50 additional biologics for internal development. Update 4th May 2021 According to Fierce Biotech, Rani Therapeutics has secured $69 million in new funding to move forward with the manufacturing and clinical testing of its “robotic pill”—a small, swallowable capsule that promises to shepherd more delicate drugs past the stomach before releasing them into the bloodstream. The pill aims to make it easier for a patient to take therapies that typically require an injection or infusion, including treatments for diabetes, arthritis and other diseases. Currently, the Fierce 15 winner is working with drugmakers Novartis and Takeda to…
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NETDetect: Earlier diagnosis of Neuroendocrine Cancer gets a boost

NETDetect: Earlier diagnosis of Neuroendocrine Cancer gets a boost

Clinical Trials
[caption id="attachment_16474" width="640" align="aligncenter"] Dr Eugene Woltering - NET Specialist[/caption] It's well known that Neuroendocrine Cancer is difficult to detect and as a consequence, many people are not diagnosed until late stages. The difficulty in detection is not just focussed on the complexity of the disease but also the lack of understanding within the medical community who don't always see sufficient evidence to refer the person on to receive expensive testing and in some cases confirmatory and expensive imaging which may not show small tumours. Currently, there's no screening test for Neuroendocrine Cancer for the simple fact that it's not a high population disease and it's not a known killer. This development from well known NET Specialist Dr Eugene Woltering could help bridge that gap although some suspicion to utilise…
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Clinical Trials – PEN-221 for Neuroendocrine Cancer

Clinical Trials – PEN-221 for Neuroendocrine Cancer

Clinical Trials
What is PEN-221?Tarveda Therapeutics is discovering and developing a new class of potent and selective precision oncology medicines for the treatment of patients with various solid tumor malignancies. Their strategy includes developing their own proprietary Pentarin miniature conjugates to enhance the effectiveness of promising anti-cancer payloads that have struggled without their selective targeting to solid tumors.  These medicines are known as 'Pentarins'. PEN-221 is the lead candidate 'Pentarin' aimed at Neuroendocrine Cancer - PEN-221.Somatostatin receptor 2 (SSTR2) is frequently overexpressed on several types of solid tumors, including neuroendocrine tumors and small-cell lung cancer. Peptide agonists of SSTR2 are rapidly internalized upon binding to the receptor and linking a toxic payload to an SSTR2 agonist is a potential method to kill SSTR2-expressing tumor cells. PEN-221 is a conjugate consisting of microtubule-targeting…
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Clinical Trials – ONC201 for Neuroendocrine Cancer (including Pheo/Para)

Clinical Trials – ONC201 for Neuroendocrine Cancer (including Pheo/Para)

Clinical Trials
What is ONC201?A company called Oncoceutics is developing a novel class of safe and effective cancer therapies called imipridones. Imipridones have a unique three-ring core structure and selectively target G protein-coupled receptors (GPCRs), the largest class of membrane receptors and a common target of approved drugs that are underexploited in oncology. Despite being historically uncommon as targets in oncology, GPCRs control an array of critical prosurvival and stress signaling pathways that are often dysregulated in human cancer to favor cancer cell survival and propagation.The ability of imipridones to target GPCRs with a high degree of selectivity represents a novel opportunity in oncology that generates remarkably safe and effective therapeutics. ONC201, the founding member of this novel class of therapies, is an orally active, safe, and selective antagonist of the GPCR…
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Surufatinib for Neuroendocrine Cancer

Surufatinib for Neuroendocrine Cancer

Clinical Trials, Treatment
UPDATE 2nd May 2022. US FDA did not approve. Commentary from Healthcare New company Global Data. "On 2 May, the US Food and Drug Administration (FDA) rejected HUTCHMED’s new drug application (NDA) for its lead candidate, Sulanda (surufatinib), for the treatment of advanced neuroendocrine tumours (NETs). Issues pertaining to trial populations were raised in a complete response letter (CRL) and GlobalData expects this case to have wide implications for the whole field of oncology therapeutics. China-based HUTCHMED received approval for its multi-receptor tyrosine kinase inhibitor Sulanda in China for the treatment of pancreatic and extra-pancreatic NETs in June last year and December 2020, respectively. Following the submission to Chinese authorities, NDAs were also submitted to the FDA and European Medicines Agency (EMA). Two large Phase III studies formed the basis…
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Clinical Trials of PV-10 (Rose Bengal) for the treatment of Neuroendocrine Tumours (NET)

Clinical Trials of PV-10 (Rose Bengal) for the treatment of Neuroendocrine Tumours (NET)

Clinical Trials
Reviewed and edited 17th March 2022Provectus Biopharmaceuticals Announces Presentation of Full Study Data from Metastatic Neuroendocrine Cancer Phase 1 Trial of PV-10® at ENETS Conference 2022Provectus (OTCQB: PVCT) today announced that data from an ongoing clinical trial of investigational cancer immunotherapy PV-10 (rose bengal sodium) for the treatment of neuroendocrine tumors (NET) metastatic to the liver (mNET) refractory to somatostatin analogs (SSAs) and peptide receptor radionuclide therapy (PRRT) (NCT02693067) was presented at the annual conference of the European Neuroendocrine Tumor Society (ENETS), held from March 10-11, 2022 in a hybrid setting in Barcelona, Spain and online.The oral presentation was made by the principal investigator of the clinical trial’s single center at The Queen Elizabeth Hospital (TQEH) in Adelaide, Australia: Tim Price, MBBS, DHlthSc (Medicine), FRACP, Head of Clinical Oncology Research…
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New Radiotracer Can Identify Nearly 30 Types of Cancer – SNMMI – 68Ga-FAPI PET/CT

New Radiotracer Can Identify Nearly 30 Types of Cancer – SNMMI – 68Ga-FAPI PET/CT

Clinical Trials, Living with Neuroendocrine Cancer
Updated 17th March 2023 When I wrote about this new PET in June 2019, it was for interest only, but I curiously noted the existence of "NET" in the list of 28 cancers.   It is designed to compete with FDG PET.  The study comes from a joint China/Singapore initiative. This update now confirms it could be more efficient than FDG for those types of cancer where FDG is the optimum imaging. Headline "A new radiotracer, 68Ga-FAP-2286, has been found to be more effective than the most commonly used nuclear medicine cancer imaging radiotracer, 18F-FDG. In a study published in the March issue of The Journal of Nuclear Medicine, 68Ga-FAP-2286 detected 100 percent of primary tumors across multiple cancer types as compared to 18F-FDG, which identified only 80 percent. 68Ga-FAP-2286 was also more effective in detecting lymph…
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LUTATHERA (PRRT) – NETTER 2 Clinical Trial for Grade 2/Grade 3 Patients Advanced GEP-NET (NETTER-2)

LUTATHERA (PRRT) – NETTER 2 Clinical Trial for Grade 2/Grade 3 Patients Advanced GEP-NET (NETTER-2)

Clinical Trials
Brief SummaryThe NETTER-1 trials led to the approval of Lu177 (or Lutathera), more commonly known in the community as Peptide Receptor Radio Therapy (PRRT).  This led to an explosion of availability across the world but many gaps in service remain.Many PRRT spin off trials are in the pipeline looking at different types of PRRT, mainly using slightly different radionuclides and techniques.  However, NETTER-2 builds on the success of the approved version formally known as Lutathera.The aim of NETTER-2 is to determine if Lutathera in combination with long-acting octreotide prolongs PFS in GEP-NET patients with high proliferation rate tumors (G2 and G3), when given as a first line treatment compared to treatment with high dose (60 mg) long-acting octreotide. Somatostatin analog (SSA) naive patients are eligible, as well as patients previously…
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Clinical Trial of Paltusotine for the Treatment of Neuroendocrine Tumours

Clinical Trial of Paltusotine for the Treatment of Neuroendocrine Tumours

Clinical Trials
Update as of 5th May 2022One Phase 2 trial has now been entered in the Clinical Trials database, based at the University of Kentucky (Markey Cancer Center).  Read the clinical trial document by clicking here.  The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and exploratory dose-response of paltusotine treatment in subjects with carcinoid syndrome. This study consists of a Randomized Treatment Phase followed by an Open-Label Extension (OLE) PhaseUpdate as of 12th January 2022.Crinetics also plans to advance paltusotine into a Phase 2 trial for the treatment of carcinoid syndrome associated with neuroendocrine tumors. Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors, today announced that Scott Struthers, Ph.D., founder & CEO…
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Clinical Trial: Treatment of IBS with diarrhoea – titrated ondansetron (TRITON)

Clinical Trial: Treatment of IBS with diarrhoea – titrated ondansetron (TRITON)

Clinical Trials
I was never diagnosed with Irritable Bowel Syndrome (IBS) but sometimes I feel like I now have it.  I know many others feel the same way.  But when I look at the alternatives, I can't help thinking it's a small price to pay given that one of them might be a slow degrading quality of life until shuffling off  this mortal coil. If I had the choice again, I would still take the surgery. Before the article continues, let me be clear - I'm not suggesting this is a potential treatment for NET patients with post abdominal surgery side effects or side effects of any other treatment, nor am I suggesting it's a potential treatment for those with carcinoid syndrome diarrhea.  I publish it because there is a connection to…
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Clinical Trial: Lenvatinib Efficacy in Metastatic Neuroendocrine Tumors (TALENT)

Clinical Trial: Lenvatinib Efficacy in Metastatic Neuroendocrine Tumors (TALENT)

Clinical Trials
"Interestingly, the ORR in pancreatic NETs was 44%, a rate not seen before with targeted agents," Jonathan Strosberg, MD, head of the neuroendocrine tumor division at Moffitt Cancer Center in Tampa Tweet Lenvatinib has completed a Phase 2 trial in Gastrointestinal (GI) and Pancreatic Neuroendocrine Tumours.  The trial was sponsored by Grupo Espanol de Tumores Neuroendocrinos (Spanish NET scientific organisation) and the manufacturers.  A European venture with sites in Austria, Italy, Spain, UK.   Headline: The responses are better than Everolimus (Afinitor) and Sunitinib (Sutent).What is Lenvatinib?It is a type of targeted therapy known as a multikinase inhibitor. The brand name is 'LENVIMA'. These work by inhibiting multiple intracellular and cell surface kinases, some of which are implicated in tumour growth and metastatic progression of cancer, thus decreasing tumour growth…
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Clinical Trial: Intra-arterial Lu177 (PRRT) for Neuroendocrine Cancer liver metastases (LUTIA)

Clinical Trial: Intra-arterial Lu177 (PRRT) for Neuroendocrine Cancer liver metastases (LUTIA)

Clinical Trials
Share on facebook Facebook Share on twitter Twitter Share on pinterest Pinterest Share on whatsapp WhatsApp Share on email Email The treatment of liver metastasis is a common approach following a metastatic diagnosis or discovery of liver metastasis downstream via re-staging. In addition to surgery, there are several liver directed therapies available via embolization techniques. This comes in several flavours:1. Bland liver embolization - a minimally invasive technique which simply blocks the blood supply to the liver tumours in an attempt to reduce or kill those tumours. Sometimes called Hepatic Arterial Embolization or HAE.2. Chemotherapy liver embolization - as above but adds in some cytotoxic chemo to the mix. Sometimes called Trans Arterial Chemo Embolization or TACE.3. Radioembolization is a minimally invasive procedure that combines embolization and radiation therapy to…
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Clinical Trial SPARTALIZUMAB  – Immunotherapy for Neuroendocrine Neoplasms (PDR001)

Clinical Trial SPARTALIZUMAB – Immunotherapy for Neuroendocrine Neoplasms (PDR001)

Clinical Trials, Treatment
UpdateTrial complete.  Conclusion abstract - Single agent PD-1/PD-L1 inhibitors have not demonstrated clinical utility in an unselected NET population and should not be used outside of clinical trials. The potential for PD-L1 inhibition in the thoracic cohort warrants further investigation.  Read more here. PDR001 (anti-PD-1) is an investigational immunotherapy being developed by Novartis to treat both solid tumors and lymphomas (cancers of the blood).  It is currently being trialled on many cancers including Neuroendocrine.  Its brand name is SPARTLIZUMAB.How PDR001 worksPDR001 is a type of immunotherapy, meaning that it acts by activating the body’s own immune system to recognize and fight cancer cells. Normally, an immune system cell called T-cells recognizes and kills infected or abnormal cells, including those that are cancerous. To prevent T-cells from accidentally damaging healthy and essential…
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Breath test with the goal of detecting multiple cancers – ready to start trials

Breath test with the goal of detecting multiple cancers – ready to start trials

Clinical Trials
While it's a long way off becoming reality, this is quite an exciting clinical trial. I have no idea if it will pick up Neuroendocrine disease but initially, patients with suspected oesophageal and stomach cancers will be asked to try the test. Later it will be extended to include prostate, kidney, bladder, liver and pancreatic cancers. It's possible that Neuroendcorine tumours in these locations might be picked up or at least show up some abnormality that triggers further checks. The fact that Cancer Research UK is involved gives me some confidence as they tend to back the strong horses. I will keep this article live and track developments. Read more by clicking here. Thanks for reading Ronny I’m also active on Facebook. Like my page for even more news. I’m also…
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Q-Sphera™ – Next Generation Somatostatin Analogue delivery system?

Q-Sphera™ – Next Generation Somatostatin Analogue delivery system?

Clinical Trials, Living with Neuroendocrine Cancer, Treatment
Share on facebook Facebook Share on twitter Twitter Share on pinterest Pinterest Share on whatsapp WhatsApp Share on email Email UPDATE: In March 2020, the decision was taken to terminate further in-house development of the MTD201 programme with immediate effect although the asset remains available for licensing. All activities connected with MTD201 have been wound down expeditiously and the manufacturing facilities in Bilbao have been closed. Following the termination of in-house development of MTD201, the Company realigned its strategy towards exploiting its Q-Sphera technology more broadly.Original Article belowIn my article listing the somatostatin analogues and their drug delivery systems pipeline (click here), there has been a very interesting development in a product called Q-Sphera (was previously known as Q-Octreotide).  In a press release, it was announced that an unnamed 'pharma giant'…
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Neuroendocrine Cancer Clinical Trial – Lutetium-177 OPS-201 (Satoreotide)

Neuroendocrine Cancer Clinical Trial – Lutetium-177 OPS-201 (Satoreotide)

Clinical Trials
This trial drug was once owned by Ipsen but they decided to sell it off.  However, in Jun 2022, Ariceum Therapeutics (Ariceum), a private biotech company developing a radiopharmaceutical product for the diagnosis and systemic targeted radiation therapy of certain hard-to-treat cancers, announced the successful investment source of EURO 25 Million.  The proceeds from the financing will enable Ariceum to further develop its lead asset and proprietary peptide derivative, satoreotide. Satoreotide is a radiopharmaceutical drug and an antagonist of the somatostatin type 2 (SST2) receptor which is overexpressed in many cancers, including certain hard-to-treat cancers such as small cell lung cancer (SCLC), high-grade neuroendocrine tumours (NETs) and neuroblastoma, an aggressive, rare type of cancer that occurs mainly in young children. Satoreotide will be used as a 'theranostic' for both the diagnosis and…
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Neuroendocrine Cancer – Short Update from NANETS 2018

Neuroendocrine Cancer – Short Update from NANETS 2018

Clinical Trials, Diet and Nutrition, Living with Neuroendocrine Cancer, Patient Advocacy, Survivorship
I would love to go to a NANETS conference but I would need sponsorship or otherwise have to fund my own way there. Seattle sounds like a great place to visit. I would even have been their twitter correspondent had they asked! I've been to the European equivalent twice, they always have theirs in Barcelona it would seem, at least NANETS uses different locations making it more interesting.  It's a scientific conference for the most part, but I guess some basic stuff is also covered. However, in the world of instant contact and communications on the internet, together with twitter, one can keep up to speed on what is or has been discussed.  One day, NANETS and ENETS will be sufficiently advanced that we can all watch the presentations from…
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Detectnet™ (64Cu-DOTATATE) – an expansion of the Somatostatin Receptor PET Imaging for Neuroendocrine Cancer

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…
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Clinical trial of 177Lu-DOTA-EB-TATE – Long-lasting radionuclide therapy for advanced neuroendocrine tumors

Clinical trial of 177Lu-DOTA-EB-TATE – Long-lasting radionuclide therapy for advanced neuroendocrine tumors

Clinical Trials
Update April 2023There is now an interventional Phase 1 clinical trial of this PRRT variant happening in Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10065, contact Contact: Lisa Bodei, MD, PhDThe clinical trial document is here NCT05475210 - this is a small trial (9 participants) and make sure you check the exclusion and inclusion criteria. Click here:177Lu-DOTA-EB-TATE in Untreated (Naïve) Adult Patients With Advanced, Well- Differentiated Neuroendocrine Tumors - Full Text View - ClinicalTrials.govIn the NewsUpdate in March 2021.  Molecular Targeting Technologies, Inc. (MTTI), a clinical stage radiopharmaceutical therapy company, announced the approval of an Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA). It enables a Phase I clinical study of the Safety and Dosimetry of its lead product, EBTATE (177Lu-DOTA-EB-TATE),…
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Sapanisertib – a drug on trial for Neuroendocrine Tumors (NET) with a pancreatic primary

Sapanisertib – a drug on trial for Neuroendocrine Tumors (NET) with a pancreatic primary

Clinical Trials, Treatment
Researchers are testing the drug Sapanisertib to see if it can halt the progression of pancreatic NETs (pNETs) which cannot be surgically removed, have not responded to other treatment, and have spread to other parts of the body. What is Sapanisertib? Sapanisertib is one of a group of targeted therapy drugs that interferes with tumor progression by inhibiting an enzyme known as mTOR which a tumor cell needs for growth.  In fact this is the same technique used in Afinitor (Everolimus), already approved for NETs. It is also being tested in a number of different advanced cancers, including bladder, kidney, breast, liver, and certain types of lung cancers, among others. The Clinical Trial The primary goal of the phase II study is to evaluate how well pNET tumors respond to Sapanisertib.…
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Update – Oncolytic Virus Trials for Neuroendocrine Cancer

Update – Oncolytic Virus Trials for Neuroendocrine Cancer

Clinical Trials
What exactly are Oncolytic Viruses?Oncolytic Viruses infect and break down cancer cells but not normal cells. Oncolytic viruses can occur naturally or can be made in the laboratory by changing other viruses. Certain oncolytic viruses are being studied in the treatment of cancer. Some scientists say they are another type of immunotherapy whilst others say it's too early to classify them as such. The good news is that Neuroendocrine Cancer seems to figure in this work with two of these viruses apparently working on mice to date. Listed below are two active projects involving NETs, one directly and one indirectly.Added 24th September 2022. A Study of CF33-hNIS (VAXINIA), an Oncolytic Virus, as Monotherapy or in Combination With Pembrolizumab in Adults With Metastatic or Advanced Solid Tumors (MAST)Neuroendocrine Neoplasms are considered…
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Targeted Alpha-emitter Therapy (TAT) – the wave of the future in nuclear oncology/PRRT?

Targeted Alpha-emitter Therapy (TAT) – the wave of the future in nuclear oncology/PRRT?

Clinical Trials
What is Targeted Alpha-emitter Therapy?Regular PRRT which is authorised for use now, i.e. Lutathera/Lu177 is a beta therapy.  Targeted Alpha Therapy is based on the coupling of alpha particle emitting radioisotopes to tumour selective carrier molecules, such as monoclonal antibodies or peptides. These molecules have the ability to selectively target tumour cells even if they are spread throughout the body. They recognize the targeted cancer cells through antigens that are expressed on the cell surface and can bind selectively to these cells, similar a key fitting into a lock. In targeted alpha therapy these carrier molecules serve as vehicles to transport the radioisotopes to the cancer cells. This is called the "magic bullet" approach. Radioisotopes that emit alpha particles seem particularly promising to selectively destroy cancer cells. Alpha particles have…
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Phase 3 Clinical Trial of 177Lu-Edotreotide (Solucin®) – COMPETE for GEPNETs

Phase 3 Clinical Trial of 177Lu-Edotreotide (Solucin®) – COMPETE for GEPNETs

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) for…
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Lanreotide for Lung NETs – SPINET Clinical Trial

Lanreotide for Lung NETs – SPINET Clinical Trial

Clinical Trials, Treatment
Reviewed and updated 19th October 2021.  Phase III trial data updatedThere's been a lot of action in the area of what is termed Gastro-Entero-Pancreatic Neuroendocrine Tumors (GEP-NETs).  It can therefore sometimes appear that Lung NETs are the poor relation.  There are certainly some unmet needs in this area of the anatomy including a lack of research.  However, there has been some recent movement. Last year, the use of Afinitor (Everolimus) was approved for progressive, non-functional NET of GI or Lung origin.SPINET Trial for Lung NETsIn late 2016, I tipped you off about an Ipsen sponsored trial for Lung NETs involving Lanreotide (Somatuline).  SPINET is a Phase 3, prospective, multi-center, randomized, double-blind, study evaluating the efficacy and safety of Lanreotide plus "Best Supportive Care" (BSC) versus placebo plus BSC for the treatment…
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Immunotherapy: Studies with Neuroendocrine Neoplasms

Immunotherapy: Studies with Neuroendocrine Neoplasms

Clinical Trials, Treatment
IntroductionThere's a lot of Immunotherapy stuff out there! However, I also wanted to break it down and perhaps see if I can pick up the what, when, why, where and how in regard to Neuroendocrine Cancer. It's difficult, not least because the picture is not clear and there is no general roadmap printed, let alone one for Neuroendocrine disease. Immunotherapy for NETs was discussed at ENETS 2017 in Barcelona. The presentation that sticks out was one given by Dr Matthew Kulke, a well-known NET Specialist in Boston. My reaction to the presentation was one of 'expectation management' and caution i.e. it's too soon to know if we will get any success and when we will get it. He also hinted that it's more likely that any success will first be…
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ASCO 2017 – Let’s talk about NETs #ASCO17

ASCO 2017 – Let’s talk about NETs #ASCO17

Clinical Trials
ASCO (American Society of Clinical Oncology) is one of the biggest cancer conferences in the world normally bringing together more than 30,000 oncology professionals from around the world to discuss state-of-the-art treatment modalities, new therapies, and ongoing controversies in the field.  As Neuroendorine Tumors is on a roll in terms of new treatments and continued research, we appear to be well represented with over 20 'extracts' submitted for review and display.  This is fairly complex stuff but much of it will be familiar to many.  I've filtered and extracted all the Neuroendocrine stuff into one list providing you with an easy to peruse table of contents, complete with relevant linkages if you need to read more.  For many the extract title and conclusion will be sufficiently educational or at least…
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All you need to know about Peptide Receptor Radionuclide Therapy (PRRT)

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

Clinical Trials, Treatment
Short PRRT PrimerWhat is Peptide Receptor Radionuclide Therapy (PRRT)?What is PRRT?  PRRT stands for Peptide Receptor Radionuclide Therapy, an FDA-approved therapy used for systemic treatment of neuroendocrine tumors.  Peptide refers to the small molecule for this therapy. The Peptide used (DOTATATE or DOTATOC or DOTANOC) is very similar to Somatostatin, a hormone which binds to receptors found on neuroendocrine tumors. Receptor refers to a specific target on neuroendocrine tumor cells that the peptide attaches to. After the peptide joins with a Receptor, it becomes attached and enters the targeted tumor cell. Radionuclide refers to radioactive atom that is attached to the peptide. As the peptide enters the cell, it brings the Radionuclide into the tumor cell. The radionuclide (e.g. lutetium-177), then decays and emits radiation within the tumor cell.Therapy refers to the idea that we are using this combination of Peptides, Receptors, and Radionuclides…
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Clinical Trial – Cabozantinib for Neuroendocrine Neoplasms

Clinical Trial – Cabozantinib for Neuroendocrine Neoplasms

Clinical Trials
What is Cabozantinib?Cabozantinib is an oral drug which works by blocking the growth of new blood vessels that feed a tumour. In addition to blocking the formation of new blood cells in tumours, Cabozantinib also blocks pathways that may be responsible for allowing cancers cells to become resistant to other "anti-angiogenic" drugs. It is a type of drug called a growth blocker.  Cabozantinib has been studied or is already in research studies as a possible treatment for various types of cancer, including prostate cancer, ovarian cancer, brain cancer, thyroid cancer, lung cancer, and kidney cancer. During my research, I found that it has a connection to Medullary Thyroid Cancer (MTC) which is a type of Neuroendocrine Cancer, frequently associated with Multiple Endocrine Neoplasia (MEN).  Cabozantinib, under the brand name of 'Cometriq'…
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Theranostics for Neuroendocrine Cancer –  A Find and Destroy Mission

Theranostics for Neuroendocrine Cancer – A Find and Destroy Mission

Awareness, Clinical Trials, Living with Neuroendocrine Cancer, Treatment
[caption id="attachment_14426" width="1200"] Courtesy of Pashtoon Kasi MD on Twitter https://twitter.com/pashtoonkasi/status/1078675398601396224[/caption] Theranostics is a joining of the words therapeutics and diagnostics. You may also see it conveyed as 'Theragnostics' and these terms are interchangeable. The basic aim of theranotistics is to find and then destroy the 'bad guys'. With Neuroendocrine Cancer, finding the tumours (the bad guys) can often be a challenge - they can be small and/or difficult to find - they are sometimes expert at camouflage. Moreover, once found, they can then be difficult to treat (destroy), as they can often prove resistant to conventional cancer drugs and many are inoperable due to sheer quantity, spread and positioning. When they are found and identified, it's also really helpful to know from the intelligence gathered, how successful the destroy…
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Clinical Trial: PRRT and Chemo combination therapy

Clinical Trial: PRRT and Chemo combination therapy

Clinical Trials
Update 2022:  Trial complete.  Results:The final results of this trial were presented at ASCO 2022 where it was concluded as follows:"CONTROL NETs is the first randomized trial to demonstrate efficacy for PRRT in pNETs, in addition to a standard of care. Extended follow up confirms durable CAPTEM/PRRT activity, with superior PFS in pNETs. Late haematologic toxicity was seen in both mNET PRRT arms but was not higher with additional CAPTEM. The activity of CAPTEM/PRRT in pNETs should be tested in the phase III setting" - click here to read the abstract. Combination treatments are common in chemotherapy, but this trial was different as it effectively combined the use of different therapies both with their own toxicity risks, albeit low in each therapy type.  The use of PRRT and chemo (in particular…
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Somatostatin Analogues and delivery methods in the pipeline

Somatostatin Analogues and delivery methods in the pipeline

Awareness, Clinical Trials, Living with Neuroendocrine Cancer
This is my live blog post covering new developments in the area of new Somatostatin Analogues and new delivery systems. AbstractAs most of you will be aware, there are currently two main types of Somatostatin Analogues (SSA) in use for the treatment of mainstream Neuroendocrine Tumours (NETs) - Octreotide and Lanreotide.  You can click on the links for information on both of these well-known NET treatments.  This post will focus on the not so well known and anything in the pipeline including different delivery systems.Those who have read the Octreotide/ Lanreotide patient leaflets will know those SSAs are also used in the treatment of a condition known as Acromegaly. You can see why the drug is used for both as they control the release of excess secretions of various substances, a…
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