Neuroendocrine Cancer Clinical Trial: Advanced Oncology Formula enterade®

Mechanism-of-Action-enterade-video-copy

Diarrhea is a huge subject for NET patients, whether it’s caused by the tumor itself (i.e. a syndrome), due to treatment, knock on effects of treatment, or some other reason, it can dramatically limit qualify of life.  Working out the root cause can be problematic even for medical teams. I wrote about these issues before in my article Neuroendocrine Cancer – the diarrhea jigsaw. So when I saw the data from a trial of something called enterade®, I was immediately drawn to investigate.  I don’t normally write articles on over the counter commercial products but this one is an exception given that it has been classed as a medical food since 2012 and is also used to rehydrate patients undergoing radiotherapy and chemotherapy for cancer (so not just for NETs).

What is enterade® ?

It’s a drink currently produced in 8oz bottles.  It’s a first-in-class, glucose-free medical food i.e. it is intended to be used under the supervision of a healthcare provider.  The solution comprises five critical amino acids – Valine, Aspartic Acid, Serine, Threonine, Tyrosine and electrolytes – potassium and sodium.

What does it do?

It’s designed to help manage debilitating gastrointestinal (GI) side effects. With no sugar to exacerbate the GI tract, enterade® supports the small bowel’s ability to absorb fluids, nutrients, and electrolytes and leads to improved digestive function. By helping to restore normal GI function, enterade® reduces diarrhea and dehydration, leading to a significant improvement in the patient’s overall quality of life and a healthier GI tract.

Is there evidence that it works?

Since May 2017, it’s been trialled by University of Kentucky Markey Cancer Center (MCC) for potential use by NET patients – trial coordinators include the well-known NET specialist Dr Lowell Anthony.  The results so far are very interesting.  The recent  conference reported revised data as follows:

  • 33 of 41 patients (80%) reported subjective improvement in diarrheal symptoms.
  • 51% (21/41) reported more than 50% reduction in diarrhea frequency.
  • click here or on the poster below to see the trial poster data output.
asco poster enterade as a graphic
click to read full screen

As you will see from the poster, there were a wide range of patient types including (but not limited to) small intestinal NETs, bronchial NETs, NETs of unknown primary, gastric NETS, pancreatic NETs and one high grade neuroendocrine carcinoma of the prostate.

A follow on Phase 2 trial is now recruiting  with the following detail available:

1. Up to 30 patients will be recruited.

2. The trial is coordinated by Markey Cancer Centre, Kentucky.

3.  There will be two cohorts, those with carcinoid syndrome and those without.

4.  The trial will run from December 2018 to August 2020.

  • Click here to see the trial information – important to note the inclusion and exclusion criteria.
  • Read the trial start announcement by clicking here.
  • Please also note there’s a plan for a follow on trial covering more locations.  I will update further when known.

Can I buy Enterade now?  

The product is available in North America on Amazon.com,  www.enterade.com and 1-855-enterade.  However, the parent company (Entrinsic Health) recently announced a partnership with global company  Nestlé Health Science to provides worldwide commercial license and supply agreement for enterade®. The announcement is linked here:

NORWOOD, Mass., November 15, 2018 – Entrinsic Health Solutions (EHS), an innovative health sciences company, today announced that they have entered into a partnership with Nestlé Health Science (NHSc), a global innovative leader pioneering premium-quality, science-based nutritional health solutions. The partnership gives NHSc the exclusive rights to market EHS’s enterade® product.

Disclaimer

Please note this is not a recommendation to go out and buy the product.  It is actually described as a ‘medical food’ and is formulated to be consumed or administered under the supervision of a physician.

Further reading:

1. Enterade FAQ – click here

2. A breakthrough for NET Patients. click here.

3. Recent output from ASCO 2018 – click here. (contact data update for 2018)

4. If you are interested in more information about how enterade® works, check out this short video

Disclaimer

Please note this is not a recommendation to go out and buy the product.  It is actually described as a ‘medical food’ and is formulated to be consumed or administered under the supervision of a physician.

Thanks for reading

Ronny

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


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Telotristat Ethyl (XERMELO®) – an oral treatment for Carcinoid Syndrome Diarrhea not adequately controlled by Somatostatin Analogues

Telotristat Ethyl is an extremely significant introduction to the treatment of Carcinoid Syndrome diarrhea. It’s the first addition to the standard of care in more than 16 years and the first time an oral syndrome treatment has been developed.  The drug was previously known as Telotristat Etiprate but was changed to Ethyl in Oct 2016. ‘Etiprate’ was previously a truncation of ‘ethyl hippurate’.  The brand name is XERMELO® 

UPDATE MARCH 2018 

The March 2018 issue of Clinical Therapeutics provides the first report of the effects of XERMELO on changes in weight in patients with neuroendocrine tumors (NETs) and carcinoid syndrome that participated in the TELESTAR study. You have to remember that XERMELO is approved for those with carcinoid syndrome diarrhea not adequately controlled by somatostatin analogues (author’s note – i.e not for diarrhea caused by (say) side effects of surgery).

Of the 120 patients with weight data available, up to 32.5% of patients treated with XERMELO experienced significant, dose-dependent weight gain (≥3% from baseline). Only 5.1% of patients on placebo experienced weight gain. Importantly, patients with weight gain experienced improvement in carcinoid syndrome control, as seen in reduction of bowel movement frequency and in parameters of nutritional status associated with positive changes in patient-reported outcomes compared with patients with stable weight or weight loss. Those patients also experienced reduced u5-HIAA levels. Patients with weight gain also experienced fewer serious adverse events than patients with stable weight or weight loss.

(see link below)

Who is the drug for?

The drug may be of benefit to those whose carcinoid syndrome diarrhea is not adequately controlled by somatostatin analogues (Octreotide/Lanreotide). It doesn’t replace somatostatin analogues – it is an additional treatment alongside (although I have heard of patients in the US being subscribed who are not receiving somatostatin analogue treatment)

Where is it currently approved?

The US FDA approved the drug 28 February 2017.

On 19 September 2017,the European Commission approved Xermelo® (telotristat ethyl) for the treatment of carcinoid syndrome diarrhea in patients inadequately controlled by somatostatin analogue therapy after the scientific committee of the EMA (known as Committee for Medicinal Products for Human Use (CHMP)) adopted a positive opinion recommending the approval of Xermelo® (telotristat ethyl) 250 mg three times a day for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analogue (SSA) therapy in adults inadequately controlled by SSA therapy. The Ipsen press release is here.  Clearly some action will be required in EC national countries before the drug becomes available through the appropriate healthcare systems.


On 17 Oct 2018, Health Canada announced approval for Canadian NET patients – click here.

For all other countries please note that Ipsen will pursue a worldwide regulatory plan for marketing authorisation submissions in the territories in which it operates. Once approved, Ipsen will be distributing the drug in all countries less USA and Japan where Lexicon retains the rights. Outside USA and Europe will be constrained by national approval timelines.

How does it work?

In the simplest of terms, the drug is an inhibitor of the enzyme tryptophan hydroxylase (TPH).  TPH is the rate-limiting enzyme in serotonin synthesis which converts tryptophan (an essential amino acid which comes from diet) to 5-hydroxytryptophan, which is subsequently converted to serotonin, one of the main causes of carcinoid syndrome effects including carcinoid heart disease.  The trial data indicates that Telotristat ethyl significantly reduced the frequency of bowel movements. Furthermore, it was also associated with “significantly reduced levels of urinary 5-HIAA“, a marker for systemic serotonin levels, which are typically elevated in severe carcinoid syndrome.  Essentially it works by reducing the manufacture of Serotonin so it’s it may not have any effect on diarrhea not caused by syndrome (i.e. post surgery etc).

telotristat-etiprate-clinical-trial-serotonin-as-a-key-driver-of-carcinoid-syndrome

Resources for your perusal:

  • You can read more about the trial data in a summary by Dr Matthew Kulke (Dana Farber) by CLICKING HERE (latest review from 2017 ASCO).
  • There is also an excellent summary in video form by Dr Lowell Anthony (University of Kentucky) by CLICKING HERE. (“any reduction in diarrhea is meaningful“).
  • The detailed output from the trial (results) can be found by CLICKING HERE.
  • Great 2016 article from ASCO (American Society of Clinical Oncologists) can be found by CLICKING HERE.
  • FDA Approval.  CLICK HERE
  • Lex Pharma press release on approval.  CLICK HERE
  • EU Approval (Ipsen Press Release).  CLICK HERE
  • The manufacturer Lex Pharma have established a dedicated site – CLICK HERE
  • 2018 revised clinical data – CLICK HERE

 

Serotonin Video with myself and Dr Mike Morse

I made a video in 2019 with Dr Mike Morse sponsored by Lexicon Pharmaceuticals, Inc.  It’s all about Carcinoid Syndrome with a slant towards hormones, in particular Serotonin. Entitled “Likely Suspects: How Hormones May Lead to Carcinoid Syndrome – What People Living With Carcinoid Syndrome Need to Know”

You need to register to watch although some of you will already be registered and just need an email to login to see the this webcast. The one I’m featured in is the latest in a series on the subject and I’d like to break the record for views please! Please help me achieve this 💙 I would also love to get your feedback and sincerely hope you will find the time to listen in.  Please also find the time to complete the survey at the end.  Thanks

Click on the link here: www.CarcinoidWebcast.com

Don’t forget to press the play button and ensure your sound is turned up, particularly on mobile devices.

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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

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

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