Clinical trial - Ronny Allan - Living with Neuroendocrine Cancer

02Aug 2023 by Ronny Allan No Comments

Phase 1 Clinical Trial AOH1996 for the Treatment of Refractory Solid Tumors

Facebook Twitter Pinterest WhatsApp Email The City of Hope-developed small molecule AOH1996 targets a cancerous variant of the protein PCNA. In its mutated form, PCNA is critical in DNA replication and repair of all expanding tumors. Here we see untreated cancer cells (left) and cancer cells treated with AOH1996 (right) undergoing programmed cell death (violet). (Photo credit: City of Hope) This particular clinical trial for solid tumours has been widely reported in the news this week (July/august 2023). It is touted as a "cancer-killing pill" has appeared to "annihilate" solid tumours in early research - leaving healthy cells unaffected. Whether these are the words of the sponsor or the media is not clear. Some of the media wording may have been based on preclinical data on animal testing. The new…

01Jun 2023 by Ronny Allan 2 Comments

Clinical Trial: Phase 1/2a Study of 23ME-00610 in Patients With Advanced Solid Malignancies (incl Neuroendocrine Neoplasms)

Clinical Trials and Research

Who are 23andMe?I personally had not heard of 23andMe but many people in North America might have. When you first look at what they do, you can be excused for thinking they are just another 'Ancestry' company, but they are more than that. They also get involved in genetics and health. To quote their marketing "we’re all of these things". Read more here: About us - 23andMe But what I found most interesting is that they have a clinical trial involving Neuroendocrine Tumors using their product 23ME-00610. However, an analysis of the documentation available indicates it is aimed at Grade 3 both well and poorly differentiated. Also includes small cell lung cancer (SCLC) and Merkel Cell Carcinoma. The results from this clinical trial were presented at a recent conference and I will…

10May 2023 by Ronny Allan No Comments

Clinical Trial: Novel Somatostatin Receptor Subtype 2 Antagonist Labelled With Terbium-161 (161Tb-DOTA-LM3) (Beta plus)

Clinical Trials and Research, Treatment

A new clinical trial post.What is Terbium-161 (161Tb-DOTA-LM3) (Beta plus).Terbium-161 is a radioactive substance. DOTA-LM3 is a novel somatostatin antagonist targeted using somatostatin receptor number 2 (SSTR2). Combined they form a radioligand for use in Pepetide Receptor Radionuclide Therapy (PRRT). It's a beta emitter but labelled 'plus' on the basis it offers more than the currently approved Luthera product (lutetium 177 or 177Lu Dotaxxx series). There is evidence that terbium-161 (161Tb) is more powerful than 177Lu, not only in combination with SST2 agonists but particularly with SST2 antagonists.Agonist vs Antagonist in the context of PRRTThe currently approved Luthera product (lutetium 177 or 177Lu Dotaxxx series) are SST2 agonists. SST2 antagonists are more efficient because they can access more binding sites on the cell surface, resulting in higher tumour uptake and…

16Mar 2023 by Ronny Allan No Comments

Experimental drug for Gastric NET – Netazepide

Clinical Trials and Research, Treatment

Gastric NETs When I wrote my post entitled "Spotlight on Gastric Neuroendocrine Neoplasms", I explained what these were with some emphasis on the association with hypergastrinemia (elevated fasting serum gastrin levels) with Type 1 and 2 gNETs being differentiated by the settings in which this occurs. This oversecretion is not the same as so called carcinoid syndrome found in other gastrointestinal NETs. Many people with a Gastric NET will already have acid reflux related issues and many will be taking medications such as proton pump inhibitors. But I was surprised to find there was not an approved targeted medication that aims to decrease gastrin levels. It's true to say that somatostatin analogues (SSA) inhibit the secretion of many NET associated hormones including gastrin but SSAs are not routinely prescribed for…

18Feb 2023 by Ronny Allan No Comments

Belzutifan for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), or Von Hippel-Lindau (VHL) Disease-Associated Tumors

Clinical Trials and Research, Treatment

What is von Hippel-Lindau disease (VHL)?Von Hippel-Lindau disease (VHL) is an autosomal dominant disease that can predispose individuals to multiple neoplasms. Germline pathogenic variants in the VHL gene predispose individuals to specific types of benign tumors, malignant tumors, and cysts in many organ systems. These include central nervous system hemangioblastomas; retinal hemangioblastomas; clear cell renal cell carcinomas and renal cysts; pheochromocytomas, cysts, cystadenomas, and neuroendocrine tumors of the pancreas; endolymphatic sac tumors; and cystadenomas of the epididymis. What is Belzutifan (Welireg)?It is an oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor. As an inhibitor of HIF-2α, belzutifan reduces transcription and expression of HIF-2α target genes associated with cellular proliferation, angiogenesis and tumor growth.On August 13 2021, FDA approved belzutifan (Welireg) to treat adults who have several tumors associated with VHL. Specifically, the drug is approved to treat VHL-associated renal cell carcinoma (a type of kidney…

17Feb 2023 by Ronny Allan No Comments

A Phase II Clinical Trial of Nivolumab and Temozolomide for Neuroendocrine Neoplasms

Clinical Trials and Research

What is Nivolumab (Opdivo)Nivolumab is a type of cancer treatment drug called an immunotherapy. It is a treatment for a number of different types of cancer. You might have it as part of a clinical trial for other types of cancer.What is Temozolomide (Temodal)Temozolomide is a type of chemotherapy. It is well known in Neuroendocrine Cancer as the TEM in CAPTEMTrial SummaryThe purpose of the trial. Treatment options are sometimes limited in patients with metastatic neuroendocrine neoplasms (NEN). The primary endpoint was response rate (using RECIST 1.1). Secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety. Immune profiling was performed by mass cytometry to evaluate the effect on peripheral blood immune cell subsets."In summary, the combination of temozolomide and nivolumab showed promising activity in NEN, especially in lung…

31Jan 2023 by Ronny Allan No Comments

Phase I study of procaspase-activating compound-1 (PAC-1) in the treatment of advanced malignancies (incl NET)

Clinical Trials and Research

Trial SummaryThis interesting trial is a multi-cancer effort including NET. The phase I clinical trial of Procaspase Activating Compound-1 (PAC-1), a drug that spurs programmed cell death in cancer cells, found only minor side effects in patients with end-stage cancers. The drug stalled the growth of tumors in the five people in the trial with neuroendocrine cancers and reduced tumor size in two of those patients. It also showed some therapeutic activity against sarcomas, scientists and clinicians report in the British Journal of Cancer. As of March 1, 2019, only patients with neuroendocrine tumors will be enrolled in Component 1 of this study. PAC-1 is taken orally on days 1-21 of a 28-day cycle. The maximum tolerated dose (MTD) of PAC-1 (5 dose levels) will be determined using a modified-Fibonacci…

03Jan 2023 by Ronny Allan 2 Comments

RonnyAllan.NET – a review of 2022

Awareness, Clinical Trials and Research, Diet and Nutrition, Inspiration, Living with Neuroendocrine Cancer, Newsletters, Patient Advocacy, Survivorship, Travel with Ronny, Treatment

ReviewIn 2022, my pet project (my blog) hit 2 million views in early November – that was a major boost. It takes 3-4 years to get a million hits based on current performance. To be honest, I’m still flabbergasted by reaching one million in 2018. It just kinda happened! I am grateful for every single view. 2022 was a challenging year, mainly because the pandemic had some latent impact on my social media activity and also in terms of growth. 2020 and 2021 were slower than normal but 2022 has seen some pickup. Some of it is due to less writing but much is due to a change in Facebook algorithms which affected many ‘pages’ reducing their scope (the more cynical might say it was done to drive advertising revenue but …….). 2022…

12Dec 2022 by Ronny Allan No Comments

Stereotactic body radiation therapy (SBRT) in the treatment of Neuroendocrine Neoplasms

Clinical Trials and Research, Treatment

What is Stereotactic Body Radiation Therapy (SBRT)? External beam radiotherapy has been around for a while. But the next generation equipment and techniques are gradually being deployed. It's a confusing area with many synonyms which I found when I wrote about the subject in a treatment summary for patients. Some of the sub-components/synonyms may be familiar to you and are often used interchangeably with SBRT; but are actually a brand name (e.g.Cyberknife) or a type (e.g. Proton Beam). You will not find SBRT mentioned in any Neuroendocrine Neoplasms (NENs) guidelines and that's because it is not a "standard of care" for this disease. If it is not a standard of care, why did I include SBRT and various techniques in the above summary? I was prompted to include this after…

02Nov 2022 by Ronny Allan 1 Comment

Alpha-emitter PRRT: A Phase 2 Open Label Study to Evaluate the Safety and Effectiveness of 212Pb-DOTAMTATE in PRRT Naive Subjects With SSTR Expressing NET

Clinical Trials and Research

Ebrahim S Delpassand, Izabela Tworowska, Rouzbeh Esfandiari, Julien Torgue, Jason Hurt, Afshin Shafie and Rodolfo Núñez Journal of Nuclear Medicine, January 2022, jnumed.121.263230; DOI: https://doi.org/10.2967/jnumed.121.263230 Update 16th May 2023. Trial’s Objective Response Rate Endpoint Already Achieved. RadioMedix and Orano Med, two clinical stage radiopharmaceutical companies, today announced that the last patient has been dosed in the Phase II trial of the targeted alpha emitter therapy, 212Pb-DOTAMTATE (AlphaMedix™). This trial is being conducted to evaluate the safety and effectiveness of AlphaMedix™ in peptide receptor radionuclide therapy (PRRT) of naive patients with somatostatin receptor-expressing neuroendocrine tumors (NET), regardless of the location of the primary tumor. Top-line data from the trial is expected in mid-2024. Remarkably, based on data already collected, the objective response rate (ORR) endpoint has already been achieved and is more than twice as high as the current standard of care. Read more hereWhat…

03Oct 2022 by Ronny Allan 2 Comments

Neuroendocrine Cancer: Glossary of Terms

Awareness, Clinical Trials and Research, Diet and Nutrition, Living with Neuroendocrine Cancer, Patient Advocacy, Survivorship, Treatment

Welcome to my Neuroendocrine Cancer Glossary of Terms list providing a source of meanings for acronyms and medical terms, all sourced from top Neuroendocrine Cancer and general cancer sites. How to use this list: 1. If your term begins with an A, click on A to find all terms beginning with A. Select your term from the list. 2. For numerical terms, please click on the hashtag (#) symbol in the A-to-Z strip. 3. The term definition including acronym or abbreviation will be given in full along with any of my published articles containing that term as long as I have tagged it on my website to display in the list. Please note I'm constantly working on the repository to clean up all definitions, adding and removing links where necessary,…

05Aug 2022 by Ronny Allan No Comments

Curtis Crump: “If I’m going down, it won’t be without a fight.”

Clinical Trials and Research, Inspiration, Patient Advocacy, Survivorship

Curtis Crump: Credit MD Anderson Cancer Center Curtis Crump has an amazing story to tell. Given 6 months to live, he refused to accept that prognosis and looked elsewhere. He found a top hospital that directed him to an established clinical trial. Although the story I am attaching says "Neuroendocrine Tumors" throughout, with that prognosis and the treatment he received (chemotherapy and immunotherapy), I'm reasonably confident he had a Neuroendocrine Carcinoma (Colon primary) or a Grade 3 Well Differentiated NET. Nonetheless, his story is relevant to many people's experiences across the broad spectrum of Neuroendocrine Neoplasms (NENs). And if I am right in my assumption, even with a poorly differentiated type, there is the hope of a better prognosis. Wishing Curtis the very best. Read his story below.(Please see my disclaimers…

20Jul 2022 by Ronny Allan No Comments

Assessment of Clinical Response Following Atezolizumab and Bevacizumab Treatment in Patients With Neuroendocrine Tumors: A Nonrandomized Clinical Trial

Clinical Trials and Research

BackgroundWell differentiated NETs have been described as an "immunological desert" in recent years mainly due to the poor response rate data coming out of clinical trials of immunotherapy drugs. Poorly differentiated NEC has favoured better but mainly in the more obscure types. Which is why these data of a combo treatment containing one immunotherapy drug caught my eye. What is atezolizumab? It is a type of monoclonal antibody and a type of immune checkpoint inhibitor. It's a Programmed cell death protein -1 (PD-1)/ Ligand 1 (PD-L1) inhibitor. A drug that binds to the protein PD-L1 to help immune cells kill cancer cells better and is used to treat many different types of cancer, including cancers that express PD-L1. Atezolizumab is used alone or with other drugs to treat certain types of…

19Jun 2022 by Ronny Allan No Comments

Clinical Trial: Triapine and Lutetium Lu 177 Dotatate for Neuroendocrine Tumors

Clinical Trials and Research

What is PRRT? I'm guessing most of my readers know what Peptide Receptor Radiotherapy (PRRT) is. But for those new to this field, read more here What is Triapine? Triapine is a ribonucleotide reductase (RNR) inhibitor, I.e. it helps repair DNA. When I research this drug, I can see it is used in numerous examples of clinical trials in an anti-cancer setting alongside radiotherapy and chemotherapy, in many cancers. Triapine in NET There is currently a trial of Triapine with Lutathera (PRRT) (11 major US hospitals). This study was testing the hypothesis that triapine is an effective radiation sensitizer that can be safely combined with peptide receptor radionuclide therapy and can improve antitumor activity of Lutetium Lu 177 Dotatate, e.g. increase the objective response rate (ORR) above that found in…

15Jun 2022 by Ronny Allan No Comments

CAPTEM for Neuroendocrine Tumours

Clinical Trials and Research

What is CAPTEM? Capecitabine is an oral drug used alone or with other drugs to treat certain types of colorectal cancer and breast cancer. It is also being studied in the treatment of other types of cancer including in combination with a second drug. Capecitabine is taken up by cancer cells and breaks down into fluorouracil, a substance that kills cancer cells. Xeloda is a type of antimetabolite. Also called Xeloda.Temozolomide is an oral drug used to treat adults with certain types of brain tumors. It is also being studied in the treatment of other types of cancer including in combination with a second drug. Temozolomide damages the cell’s DNA and may kill cancer cells. It is a type of alkylating agent. Also called Temodar.Capecitabine (brand name Xeloda) plus Temozolomide (brand…

09Jan 2022 by Ronny Allan No Comments

Clinical Trial: Lutathera and ASTX727 in Neuroendocrine Tumours (LANTana)

Clinical Trials and Research, Patient Advocacy, Treatment

What is the aim of this clinical trial?The aim of this single location trial in Imperial College London is to determine whether pre-treatment with ASTX727 results in re-expression of SSTR2 in patients with metastatic NETs, using 68Ga-DOTA-TATE to image epigenetic modification of the SSTR2 locus allowing subsequent treatment with Lutathera(i.e. PRRT). Patients entered into the study will receive ASTX727 orally up to 3 to 8 days prior to receiving Lutathera treatment. What is ASTX727?Oral Decitabine and Cedazuridine (ASTX727) is a DNA methyltransferase (DNMT) inhibitor currently being used in a trial to facilitate oral treatment of certain drugs for adults with intermediate and high-risk myelodysplastic syndromes (MDS) including chronic myelomonocytic leukemia (CMML).This is extremely technical, but from a study conducted by scientists at Imperial College London, they acknowledged that significant number of…

13Nov 2021 by Ronny Allan 6 Comments

A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot (CAM2029) in Patients With GEP-NET (SORENTO)

Clinical Trials and Research, Treatment

Some of the key differences between Lanreotide and Octreotide long-acting are:1. Octreotide long-acting needs constituting prior to administration - Lanreotide comes prefilled. 2. Octreotide long-acting is administered intra-muscular, Lanreotide is deep subcutaneous. 3. I probably should add Octreotide LAR cannot be self-injected but Lanreotide can. I suspect this type of delivery system may open up that possibility for Octreotide LAR. So, this clinical trial caught my eye. A version of octreotide long-acting which is prefilled and given subcutaneously. Plus, the manufacturers say it has a much higher bioavailability than the standard product Sandostatin LAR (bioavailability is the proportion of a drug or other substance which enters the circulation when introduced into the body and so is able to have an active effect).CAM2029 might therefore be considered a generic of Sandostatin LAR but better…

26Oct 2021 by Ronny Allan No Comments

CAR-T clinical trials for Neuroendocrine Cancer

Clinical Trials and Research, Treatment

What is CAR-T?CAR-T – chimeric antigen receptor T-cell – therapy is specifically developed for each individual patient and involves reprogramming the patient’s own immune system cells which are then used to target their cancer, i.e. it's an immunotherapy. It is a highly complex and potentially risky treatment, but it has been shown in trials to cure some patients, even those with quite advanced cancers and where other available treatments have failed.The treatment involves several steps over a number of weeks. First the patient’s blood is taken and is sent off to the manufacturer’s laboratory. Here the patient’s blood is ‘trained’ to fight the cancer cells. The CAR-T blood is then transported back to the hospital and the patient is administered with the CAR-T to treat their condition.It has not been deployed in…

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 and Research

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)…

18Sep 2021 by Ronny Allan No Comments

New Clinical Trial – Testing Lutetium Lu 177 Dotatate in Patients With Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine Tumors

Clinical Trials and Research

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, I…

13Jul 2021 by Ronny Allan No Comments

Every picture tells a story (point, click, read)

Awareness, Clinical Trials and Research, Diet and Nutrition, Inspiration, Living with Neuroendocrine Cancer, Newsletters, Patient Advocacy, Survivorship, Treatment

I always try to use graphics for a number of pictures, I admit mainly to catch people's attention but also because sometimes a picture on its own tells a story or at least provides a great introduction to one. If the picture catches your eye, clicking on will take you to the text. This post will auto update as new blogs are published. thanks for reading and sharing! Scroll, point, click, read, share! Click here and answer all questions to join my private Facebook group Share on facebook Facebook Share on twitter Twitter Share on pinterest Pinterest Share on whatsapp WhatsApp Share on email Email Thanks for reading. Ronny I’m also active on Facebook. Like my page for even more news. Help me build up my new site here –…

10May 2021 by Ronny Allan 3 Comments

Neuroendocrine Tumour (VMT-𝛼-NET) programs

Clinical Trials and Research

Viewpoint Molecular Targeting Announces First Neuroendocrine Tumor Patients Dosed with Therapeutic IntentJan 23, 2023In early December, VMT-α-NET, the Company’s lead drug for the treatment of neuroendocrine tumors was administered to patients in India on a compassionate use basis, independent of a planned US trialNo acute adverse reactions were observed in the first 10 days post administration and patients remain stable and in good conditionCORALVILLE, Iowa –Viewpoint Molecular Targeting®, Inc., a precision oncology company developing alpha-particle therapies and complementary diagnostic imaging agents, today announced the first dosing of two neuroendocrine tumor patients with therapeutic intent. VMT-α-NET, which is being developed for the treatment and diagnosis of somatostatin receptor subtype 2 (SSTR2) expressing neuroendocrine tumors, was administered to the patients in early December. The dosed patients were diagnosed with confirmed-advanced somatostatin expressing…

17Jan 2021 by Ronny Allan No Comments

Lanreotide and Keytruda – the PLANET study (NCT03043664)

Clinical Trials and Research

Headline: Roughly 40% of patients with advanced, progressive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) treated with pembrolizumab (Keytruda) in combination with lanreotide (Somulatine Depot) achieved stable disease, according to results from the phase 1b/2 PLANET clinical trial presented during the 2021 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancer Symposium.I've written about Pembrolizumab (Keytruda) before in my general immunotherapy coverage - click here. I did note they weren't really having much luck with Neuroendocrine Neoplasms although I do see some success (.... but not enough) in poorly differentiated carcinomas. Well differentiated NETs remain an immunological desert. However, this poster abstract from ASCO GI conference caught my eye.“Pembrolizumab has antitumor activity in a subset of GEP-NETs patients,” wrote the investigators. “We hypothesized that the lanreotide, by its antitumor effects and reduction of serotonin,…

21Dec 2020 by Ronny Allan 2 Comments

Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine Tumors – PRRT vs Everolimus

Clinical Trials and Research

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,…

22Jun 2020 by Ronny Allan No Comments

Targeted Therapy for Neuroendocrine Cancer – Everolimus (Afinitor)

Clinical Trials and Research, 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…

18Jun 2020 by Ronny Allan 1 Comment

My interview with ITM – I’m still here!

Awareness, Clinical Trials and Research, 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…

09Feb 2020 by Ronny Allan 3 Comments

Oral Octreotide using RaniPill™

Clinical Trials and Research

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…

11Dec 2019 by Ronny Allan 1 Comment

NETDetect: Earlier diagnosis of Neuroendocrine Cancer gets a boost

Clinical Trials and Research

[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…

24Sep 2019 by Ronny Allan 1 Comment

Clinical Trials – PEN-221 for Neuroendocrine Cancer

Clinical Trials and Research

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…

09Sep 2019 by Ronny Allan No Comments

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

Clinical Trials and Research

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…

29Jul 2019 by Ronny Allan No Comments

Surufatinib for Neuroendocrine Cancer

Clinical Trials and Research, 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…

04Jun 2019 by Ronny Allan 4 Comments

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

Clinical Trials and Research, Treatment

Sep 25th, 2023. NETTER-2 trial Novartis radioligand therapy Lutathera® demonstrated statistically significant and clinically meaningful progression-free survival in first line advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs) Read more by clicking here. Original blog below. Brief Summary - The 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…

21May 2019 by Ronny Allan 5 Comments

Clinical Trial of Paltusotine for the Treatment of Neuroendocrine Tumours

Clinical Trials and Research

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…

22Jan 2019 by Ronny Allan 3 Comments

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

Clinical Trials and Research

"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…

20Dec 2018 by Ronny Allan 7 Comments

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

Clinical Trials and Research, 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'…

Tag: Clinical trial