NETwork with Ronny © – Community Newsletter DECEMBER 2017

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HAPPY NEW YEAR and welcome to Ronny Allan’s Community newsletter for December 2017. A quieter month due to the holiday season in the latter half.  I was generally quieter in the first half too, maybe that’s a good thing? Nonetheless, I still managed to accumulate nearly 20,000 hits this month.

At the end of 2017, I’ve been reflecting on the amazing support from you guys.  I’m a bit ‘discombobulated’ but also proud to see that I’ve had an amazing quarter of a million hits on my blog site in 2017 alone, double the 2016 figure.  It seems almost impossible to carry that momentum on in 2018 but I’ll give it a go!  Check out my top 6 posts of 2017 by clicking here.

AND ….. I’m now officially ronnyallan.NET (how apt is that!)

ALSO …. I’m offering Google translate on each blog page and post to better service my international followers.

language

I caught this news in my social media NET

  1. NET Incidence UK. New figures from Public Health England confirms the incidence of NETs continues to rise supporting my 2 year old article indicating it was not rare, just less common.  The data was published quietly by NET Patient Foundation in their December 2017 newsletter. Check out the new data by clicking here.
  2. PRRT. Anticipation is rising awaiting the US FDA approval and a NICE statement on expansion in England.  In Scotland, I have anecdotal evidence that PRRT is being set up as a routine service in Glasgow Beaston (will update you when I have something concrete).  Read the updated post here.
  3. Pheochromocyoma/Paraganglioma.  Check out news of a new drug in the pipeline – Azedra (not approved yet) – click here.

Blog Site Activity  

Due to the vagaries of Facebook inner workings, some of these articles created or majorly updated in Dec 2017 may not have even shown on your timeline.  So, ICYMI …….here’s a summary with links, includes updated blogs. You can actually sign up to receive my blog articles direct to your inbox when published – subscribe here.

  NETs – A Surveillance Society – make sure you are getting the right checks
  Updated version of Somatostatin Analogues Pipeline (including news of delivery systems – smaller needles, nasal spray, capsules)
  Great video update from Dr Jonathan Strosberg

graphic courtesy of ITM AG
Expanding PRRT update
  My November Newsletter in case you missed it.

Other Activity

December was quiet but I’m out there looking for opportunities to spread awareness and advance the cause of Neuroendocrine Cancer patients.  Thank you all so much for the support in helping me do this.

  • Please join my 2018 awareness campaign event here (select ‘Going’)

  • I continue to receive a steady flow of private contacts, mainly from patients seeking information.  I don’t have an issue with private contact but please note my disclaimer
  • Please also note that due to sheer numbers of requests, I cannot accept telephone or video calls on a one to one basis. Please just message me and I will respond – see “Send Message” button when you CLICK HERE. (also please ‘Like’ this page if you have not already done so)
  • The number of non-patients contacting me for other reasons (mainly to help with something) continues to grow and this is producing some great publicity and awareness.
  • In December, the total number of people from USA on my main Facebook page exceeded 3000 – check out the announcement here.

New Audiences for NET Cancer

From Day 1, I said it was my aim to find new audiences for NETs rather than just share stuff within our own community. I’m doing this although it may not always be apparent.

  • Article features.
    • Cure Magazine.  I’ve been accepted as a ‘Cure Today’ contributor which means my articles will get a wider distribution than they do now.  Cure Magazine has a readership of 1 million.  Click here to read more. In October, I was featured in Cure Magazine twice.  I have been so busy in 2017 but I have plans to increase my presence there in 2018:
“Cancer isn’t all about me”
“Poker Face or Cancer Card”
  • Twitter. I’m ‘extremely’ active on twitter and I find a lot of research stuff there, in addition to new audiences. I also use it to support other conditions and it’s mostly returned (i.e. others help with NET awareness and are made aware of NETs in the process).  There are people regularly retweeting my stuff who do not have a personal interest in NETs. In Dec, I tweeted 140 times on my personal account which led to over 100,000 views.  I was mentioned 90 times by other tweeters, 2526 people looked at my profile and I gained 40 new followers.  My tweet “Ignore this post” remains the most tweeted article about NETs ever posted on twitter.  Check it out – click here.
  • Daily Newsletter from my twitter feed (Nuzzel).  There is so much on twitter that I could swamp the community Facebook site so I started a twitter newsletter via an app called Nuzzel which seeks out stuff I normally like. This has been a huge success from my point of view. Click this link and sign up if you think this is something you’d be interested in receiving – you don’t need to have a twitter account to read, just sign up with an email.  I’ve been pushing this newsletter quite a bit in Dec which has upped my subscriber base to 415 – a 10% increase on last month.
  • WEGO. I continue to be featured by ‘external’ organisations such as WEGO and my PODCAST is reaching new audiences – click here.  The recent awards will continue to showcase my work which has the effect of spreading Neuroendocrine Cancer awareness to NEW audiences in addition to enriching my experience as a Patient Leader.  WEGO is a fantastic organisation!

WEGO Awards

Speaking Engagements

On 16 November, I spoke for around 45 minutes at an Ipsen sponsored NET Nurse event in Birmingham. Tough gig!  Post to follow when I have the official photos. Still waiting on feedback from the sponsor.

Watch this space as I’m working on quite a few projects concurrently.

Social Media and Stats

Blog Milestone.  In December, I accelerated past 445,000 views! Thank you all so much Keep sharing!  On track for half a million by end of February 2018.

Facebook Milestone.  I would love to have achieved 6000 followers by the end of 2017 but that is now an almost impossible challenge without your direct involvement!  The Facebook page is now my biggest outlet for awareness and education so please please please recommend this page to anyone you think would be interested. There are buttons to share the page and invite others to ‘Like’ it.

Also check out my sister Facebook sites here (go to these pages and click on ‘Like’)

These are fallback  sites to counter the Facebook algorithm whereby you may not see all my posts on the main site (click on the links to see the pages)

Ronny Allan’s Community

Neuroendocrine Cancer Awareness and Networking

Instagram

I’m expanding into Instagram to see how that goes. I’ve amassed over 240 followers to date. Initially, I’ll just be posting pictures of things that inspire me, mostly scenic photos of places I’ve been or want to go!  You can follow me here:  Click here to go to my Instagram page

Community Statistics (the measurement of my efforts on your behalf)

Figures

An amazing amount of awareness and hopefully, support for others.  However, I cannot do this without you guys liking, commenting and sharing!  The likes give me motivation, the comments and private messages give me inspiration or at least a chance to explain further – and they also keep me humble.  The sharing gives me a bigger platform.  A bigger platform generates more awareness.

Thanks for your great support in December.  Onwards and upwards!

Thanks for reading

Ronny

I’m also active on Facebook.  Like my page for even more news.  I’m also building up this site here: Ronny Allan

Disclaimer

My Diagnosis and Treatment History

Most Popular Posts

Sign up for my twitter newsletter

Remember ….. in the war on Neuroendocrine Cancer, let’s not forget to win the battle for better quality of life!

Somatostatin Analogues and delivery methods in the pipeline

As 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.

This is my live blog post covering new developments in the area of new Somatostatin Analogues and new delivery systems. 

Abstract

As 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 problem that has an effect on both conditions. In the case of Acromegaly, the condition is typically caused by pituitary tumours that oversecrete the growth hormone leading to elevated levels of IGF-1. Like NETs, Octreotide/Lanreotide is currently the mainstay non-surgical treatment for this condition. For those not aware of Acromegaly there is a nice infographic explaining it here.   

Delivery methods discussed in this post include: a smaller, faster and easier Octreotide injection, an Octreotide capsule, an Octreotide nasal spray.  Other somatostatin analogues includes Pasireotide which has already been approved for Cushing’s Syndrome and Acromegaly (core NET possibilities have been investigated) and a new kid in the pipeline called Veldreotide for Acromegaly but potential additional applications in Cushing’s syndrome and neuroendocrine tumors. Finally for those with an interest in Cushings, a drug currently in phase 3 trials called RECORLEV™ (Levoketoconazole) which is not actually a somatostatin analogue, rather it’s a cortisol synthesis inhibitor.

It’s important to understand that NETs and other conditions including Cushings and Acromegaly, very often share the same hormone inhibiting drugs, thus why any development for these type of drugs is of interest to all physicians and patients in the associated conditions.

It’s also useful to understand that many of these drugs/delivery mechanisms are driven by availability of funding and are subject to the vagaries of the market. One entry on the previous version of this article has been removed as the company manufacturing it went into administration (Solid Dose Injections).

Somatostatin Analogues – New Delivery Methods in the Pipeline

New delivery system for Octreotide LAR – “Q-Octreotide” (MDT201)

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MTD201 (Q-Octreotide)

Updated 14 Dec 2017. Midatech Pharma has reported good results from a pre-clinical study of Q-Octreotide, its treatment for the side effects of Neuroendocrine tumours. The company’s speciality is drug delivery systems and MTD201 (Q-Octreotide) is a sustained release version of Octreotide designed to treat the incapacitating symptoms of metastatic Neuroendocrine Tumours, such as severe diarrhea and flushing. Q-Octreotide compared favourably with the standard Octreotide product and current market leader Sandostatin for acromegaly and carcinoid syndrome.

Apparently, the delivery method (see picture) is smaller, faster, easier. This project is expected to commence a Pilot study to compare the pharmacokinetics of Q-Octreotide versus Sandostatin LAR in humans mid-2017, followed by potential regulatory filings in 2018/19 and possible market approvals in the United States and the European Union thereafter. More to follow when known but in the meantime, please see a useful Video about Q-Octreotide. Apologies for the use of the out of date term ‘carcinoid‘.

New Octreotide Delivery Method – Chiasma Capsule

mycappsa
Octreotide Capsules? Graphic from http://www.chiasmapharma.com/

Updated 14 Dec 2017. Acromegaly appears to be in the lead in terms of new delivery methods.  A pharma company called Chiasma is working on an oral version of Octreotide for this condition and they are currently at Phase 3 trials.   You can check out the technology here.

Clearly, we want drugs to be safe and the announcement is another reminder of why drugs take so long to be approved.  Chiasma’s investigational oral octreotide uses their proprietary TPE® (Transient Permeability Enhancer) technology to facilitate gastrointestinal absorption of the unmodified drug into the bloodstream safely (i.e. it keeps the drug safe until it reaches its destination).  Hopefully, the new trial can convince the FDA to finally approve.  The trial is currently only Acromegaly based and details are here.

This is potentially an exciting development given that both conditions use the same drugs (Octreotide and Lanreotide injections) so there is always the hope that NETs might be next in line if the capsule version is finally approved.  However, still very early days as the company does not anticipate the release of top line date from the Phase 3 trial until 2020. 

Intranasal administration of Octreotide Acetate 

intravail
Nasal Spray Octreotide?

Updated 14 May 2017.  Dauntless Pharmaceuticals, Inc., a privately held biopharmaceutical company focused on the development of specialty therapeutics, announced the outcome of a Phase 1 clinical study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of DP1038, a novel formulation of octreotide acetate for intranasal administration, compared to subcutaneous Sandostatin® (octreotide acetate) injection in healthy volunteers.  DP1038 (octreotide acetate for intranasal administration) is being developed via the 505(b)(2) regulatory pathway for the treatment of acromegaly and neuroendocrine tumors.  DP1038 leverages patented technology for enhanced intranasal absorption developed by Aegis Therapeutics, LLC, a drug delivery and drug formulation company that has successfully licensed its technology to leading pharmaceutical and biopharmaceutical companies whose partners have multiple late stage clinical programs under development. The drug will most likely use an administration system patented by Aegis called Intravail® Aegis Therapeutics LLC announced last year that it has been awarded U.S. Patent No. 9,446,134 providing non-invasive metered nasal spray delivery of Octreotide (click here to view the announcement). The enabling Aegis Intravail formulation technology is broadly applicable to a wide range of small molecule and biotherapeutic drugs to increase non-invasive bioavailability by the oral, nasal, buccal, and sublingual routes and to speed attainment of therapeutic drug levels in cases where a non-invasive (i.e., non-injectable) form of the drug is unavailable or where speed of onset is important.  A description of Intravail delivery systems can be found by clicking here.

About the Phase 1 Trial
The Phase 1 trial was designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of DP1038, a novel formulation of octreotide acetate for intranasal administration, compared to subcutaneous Sandostatin® (octreotide acetate) Injection in healthy volunteers. In Part 1 of the study, each of 12 subjects received three doses of DP1038 plus 100 micrograms of subcutaneous octreotide acetate in a randomized 4 x 4 Latin square design. DP1038 was well tolerated across all doses and demonstrated a consistent, dose-proportional pharmacokinetic profile with significant nasal bioavailability. In Part 2 of the study, a single dose of DP1038, which was selected to exhibit a similar pharmacokinetic profile to subcutaneous octreotide acetate, was evaluated in 20 subjects in a cross-over design to compare the pharmacodynamic effect to 100 micrograms of subcutaneous octreotide acetate. Subjects were given a GHRH-arginine challenge, a standard test to stimulate growth hormone release, followed by administration of DP1038 or subcutaneous octreotide acetate. DP1038 showed comparable growth hormone suppression to the subcutaneous reference product. The news announcing the output from the Phase 1 clinical trial can be found by clicking here. Clearly, this is very early days and the product would need to go through the normal drug approval and acceptance routes etc.  However, a Phase 1 trial using patients is very exciting.

New Somatostatin Analogues in the Pipeline

New Somatostatin AnaloguePasireotide

signiforlar-22

Updated 14 Dec 2017.  Not really new but I wanted to include it because it’s not very well-known. Pasireotide is also known as Signifor and SOM230.  This drug is already in the pipeline but only for Acromegaly and Cushing’s Syndrome.  I found it interesting that is able to function as a multireceptor-targeted SSA by binding with high affinity to 4 of the 5 somatostatin receptors (sstrs 1, 2, 3 and 5), with the highest affinity for sstr5, resulting in inhibition of adrenocorticotropic hormone (ACTH) secretion (Octreotide only binds to sstrs 2, 3 and 5). In fact, Signifor represents the first specific treatment for ACTH-secreting pituitary adenomas.  Moreover, it is the first approved medical treatment for Cushing’s disease.  If you’ve read my blog on NET Syndromes, you will see the connection – both involve pituitary tumours and this drug is designed to cater for scenarios where surgery has not solved the problem or is not an option. Interestingly Novartis describes it as a second generation SSA, inferring that Octreotide is first generation.  It comes in short and long acting (LAR) forms with a similar delivery system to Octreotide. It is a US FDA approved orphan drug and is also approved for use in the EU.  Novartis has also submitted additional regulatory applications for Signifor LAR worldwide.   You can read more by clicking here

However, there have been studies in its use for advanced NETs where Octreotide is not working or has not sufficiently controlled the effects of the syndrome.  You can read a full text article about the study results by clicking here (you will recognise some of the authors including Edward M Wolin, Christos Toumpanakis, John Ramage, Kjell Öberg).  My interpretation of the trial conclusion is that there does not appear to be any significant advantages of Pasireotide over Octreotide.  The attachment also confirmed studies are ongoing including a potential combination treatment of Pasireotide and Everolimus (Afinitor).  There does not appear to be a study comparing it to Lanreotide.

Jonathan R. Strosberg, MD, associate professor at H. Lee Moffitt Cancer Center, discussed pasireotide as a potential treatment for patients with neuroendocrine tumors (NETs). He said “Pasireotide is a somatostatin analog similar to octreotide (Sandostatin) and lanreotide (Somatuline). However, pasireotide targets 4 out of the 5 somatostatin receptor subtypes, which may provide it with an advantage over the other 3 agents. Thus far, there has not been enough evidence showing that pasireotide has a progression-free survival benefit over the other 2 therapies. It is also associated with hyperglycemia. Pasireotide may be an appropriate choice for patients in later lines of therapy. In the future, he envisions that patients could be selected for therapy based on their somatostatin receptor profile.”

New Somatostatin Analogue  – Veldoreotide (COR-005)

Updated 14 Dec 2017. There is another new drug in the pipeline currently known as Veldoreotide or COR-005 (although I can see the term ‘Somatoprim’ used on other searches). COR-005 is an investigational SSA in phase 2 development for treatment of patients with Acromegaly. Although the page on the manufacturer’s website does not mention NETs, an announcement of its progress has just been made at the Endocrine Society’s annual conference for 2016. The announcement states that the drug has “potential additional applications in Cushing’s syndrome and neuroendocrine tumors”.  COR-005 targets somatostatin receptors 2, 4 and 5. Read about the drug here.

COR-005 has received orphan drug designation (only for Acromegaly) in the US and EU. There is not enough data to understand how this might benefit NETs and what the differences would be.  Hopefully, an update will be available later which will result in an update to this post.

For those interested in Cushing’s Syndrome, (hypercortisolism or high levels of cortisol), the same manufacturer working on Veldoreotide is also working on a new drug in Phase 3 trials known as RECORLEV™ (Levoketoconazole). Not actually a somatostatin analogue, rather it’s a cortisol synthesis inhibitor

Summary

This information is provided for information only.  There is no intent to indicate at this point that these new drugs will eventually be approved for NETs.  However, it’s another indication that people are working on new treatments which might end up being available at some stage.

The pipeline for new treatments and methods of delivery continues to grow!

Thanks for reading

Ronny

I’m also active on Facebook.  Like my page for even more news.  I’m also building up this site here: Ronny Allan

Disclaimer

My Diagnosis and Treatment History

Most Popular Posts

Sign up for my twitter newsletter

Remember ….. in the war on Neuroendocrine Cancer, let’s not forget to win the battle for better quality of life!

patients included

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