64Cu-Dotatate is a PET diagnostic agent being studied for somatostatin receptor expressing neuroendocrine tumors (NETs). RadioMedix Inc. has completed the Phase III clinical trial of the agent and expects to file a New Drug Application with the FDA in 2019. “If approved, 64Cu-Dotatate will be an exciting new diagnostic agent for the detection of neuroendocrine tumors,” said Ebrahim Delpassand, MD, CEO of RadioMedix. “The FDA Fast Track designation of 64Cu-Dotatate highlights the public health need by enhancing the availability of diagnostic radiopharmaceuticals for patients with neuroendocrine tumors. 64Cu-Dotatate is anticipated to be the first neuroendocrine PET diagnostic available to all medical centers with PET capability across the country. This will address the shortage or lack of availability of somatostatin analogue PET agents that many geographies in the U.S. are experiencing.” Link to the full press release.
Find news articles, interviews, documents and other resources regarding neuroendocrine cancer treatments and therapies, and the Healing NET Foundation.
- Jan 10, 2019 RadioMedix and Curium Announce FDA Fast Track Designation For 64Cu-Dotatate Jan 10, 2019
- Aug 17, 2018 Aretha Franklin's Passing Brings Attention to Pancreatic Neuroendocrine Tumors (PNETs) Aug 17, 2018
- Jul 5, 2018 GRIEVING MOM'S JOURNEY TO RUN IN 50 NATIONAL PARKS IN HONOR OF DAUGHTER NEARS THE FINISH LINE Jul 5, 2018
- Jul 5, 2018 Two Physicians in Neuroendocrine Cancer Field Named To Nation’s Top 40 Under 40 in Cancer Jul 5, 2018
- Jun 25, 2018 A New Solution for NET Patients: Data Featured at ASCO 2018 Jun 25, 2018
- May 31, 2018 European Physician Exchange Summary May 31, 2018
- January 2018
- Dec 5, 2017 Eric Liu Receives NCAN's Above and Beyond Award Dec 5, 2017
- July 2017
- May 5, 2017 Healing NET Summit 2017—Unmet Needs of the NET Patient Community May 5, 2017
- Feb 28, 2017 Xermelo approved for Carcinoid Syndrome Feb 28, 2017
- Feb 10, 2017 MEDIA ADVISORY Top Neuroendocrine Cancer Experts to Converge at Second Annual International Healing NET Foundation Summit February 2017 Feb 10, 2017
- Jan 31, 2017 NETS at ASCO GI Jan 31, 2017
- Jan 13, 2017 New Drug in Development Shows Improved Progression-Free Survival for Patients with Advanced Metastatic Midgut Neuroendocrine Tumors Jan 13, 2017
- Jan 13, 2017 NETTER -1 Phase III Trial results on Lutathera is published in New England Journal of Medicine Jan 13, 2017
- Nov 18, 2016 Hero of Hope Finalist Nov 18, 2016
- Nov 1, 2016 Journal of Clinical Oncology article on clinical study of telotristat ethyl in patients with carcinoid syndrome Nov 1, 2016
- Jul 22, 2016 NEWS ABOUT ADVANCED ACCELERATOR APPLICATIONS Jul 22, 2016
- Jun 2, 2016 Green Light for Ga68! Jun 2, 2016
- Feb 28, 2016 Healing NET Foundation Summit delivers on NET-Cancer discussions Feb 28, 2016
- Feb 3, 2016 MEDIA ADVISORY Feb 3, 2016
- Nov 9, 2015 Patient-Doctor Relationship Survey Results Announced Nov 9, 2015
- Oct 29, 2015 PSA: World NET Cancer Awareness Day is November 10 Oct 29, 2015
- May 14, 2015 PRESS RELEASE: NET surgeon Dr. Eric Liu moves practice to Denver May 14, 2015
- December 2014
The nation mourns the passing of legendary musician and recording artist Aretha Franklin from "pancreatic cancer of the neuroendocrine type" (according to a statement by her publicist). Many news reports mention pancreatic cancer as the cause of her death but more specifically she had a neuroendocrine tumor located in her pancreas (pNET). Neuroendocrine cancer makes up 5-6% of the cases of cancer found in the pancreas. Neuroendocrine tumors can appear in a variety of sites in the body. Download the NET Primer to read more about neuroendocrine tumors.
Healing NET issued a press release with comments from Aretha's physician Dr. Philip A. Philip and Healing NET co-founder and chief medical director Dr. Eric Liu in the hope that members of the press will get the story of this disease straight. Greater awareness can lead to quicker diagnosis and better outcomes for patients.
Here are some links to other posts that seek to set the record straight about pancreatic NETs:
This blog post by Dr. Eric Liu describes PNETs (pancreatic neuroendocrine tumors).
J. Leonard Lichtenfeld of the American Cancer Society posted on the distinction between the two cancers. Chris Lozina, who hosts the online group, Dr. Liu's Zebras, is the patient advocate referred to in this article: "Aretha Franklin Died From Pancreatic Neuroendocrine Tumor, Not Pancreatic Cancer. There Is A Difference."
- LACNETS also has a blog post on the Queen of Soul with further links that discusses the difference and why it matters to the NET community.
Running for Anna Rose and NET (neuroendocrine cancer) awareness: With only 10 national parks to go, Gil Schaenzle will end her nine month long journey August 4 at Denver's Rocky Mountain National Park wtih a half marathon. READ FULL PRESS RELEASE
Nashville, TN – The Healing NET Foundation congratulates Daneng Li, MD, City of Hope, Los Angeles, CA and Heloisa Soares, MD, University of New Mexico, Albuquerque, NM for being recently named to the nation’s top “40 Under 40 in Cancer.” The award, which was presented during a cocktail reception on June 2 in Chicago, was created by The Lynx Group™ and McGivney Global Advisors, as a means of celebrating the contributions that individuals under the age of 40 are making to improve the lives of those affected by cancer. READ MORE
CLICK HEREfor original Press Release on all 40 candidates by The Lynx Group/McGivney
This article is provided to Healing NET Foundation by Enterade in conjunction with a study presentation given recently at the annual American Society of Clinical Oncology meeting June 1-5, 2018
Earlier this month, thousands of healthcare professionals, scientists, and patients gathered together in Chicago to hear the latest scientific breakthroughs redefining cancer care at the American Society of Clinical Oncology (ASCO) 2018 Annual Meeting.
Over the course of this five-day conference, hundreds of researchers provided much-anticipated clinical and treatment updates that can help cancer patients regain their sense of self. Of these breakthroughs, one study specifically focused on reducing the most common debilitating symptom for neuroendocrine tumor (NET) patients: diarrhea.
More than 100,000 people in the U.S. live with neuroendocrine cancers and many suffer from long-term, chronic diarrhea – sometimes seen up to 20 times a day. Not only do NET patients suffer from the physical aspects of diarrhea, but it also takes an enormous social and emotional toll on patients. Many people limit their social involvements and feel isolated. With patients living for many years with this disease, there is a large unmet need for solutions that can reduce the frequency of diarrhea, so patients can start to live their life again.
Researchers at the University of Kentucky Markey Cancer Center conducted a pilot study to see if a glucose-free, amino acid oral rehydration solution, called enterade®, could reduce diarrhea frequency in NET patients. Patients drank an 8 oz bottle of enterade twice/day for one week. Data was available on 23 patients at the time of abstract submission. Results showed:
● 73% (17/23) of NET patients reported improvement in diarrhea ● 52% (12/23) reported more than 50% reduction in diarrhea frequency
These results are a big deal for NET patients, who are looking for solutions that can be incorporated into their everyday life. According to Aman Chauhan, MD, Hematology and Oncology Fellow at the University of Kentucky: “This study shows that enterade can be an effective alternative for patients with NET-related diarrhea, who need better treatment options. The proprietary combination of critical amino acids and electrolytes in enterade uniquely addresses the core contributors to NET-related diarrhea, dehydration, and compromised GI functioning.”
For NET patients, enterade can lead to a marked improvement in overall quality of life and a healthier gastrointestinal (GI) system – and it’s available without a prescription and no sugar to cause further GI dysfunction. The Markey Cancer Center will continue to share updated results at future scientific conferences over the next several months to help raise awareness of innovative solutions that can help people living with NETs regain their freedom.
Cindy Lovelace, Executive Director of HNF, talks with Dr. Dan Granberg at the 2018 Summit. Post-Summit, Dr. Granberg completed the Healing NET Foundation European Physician Exchange in Denver, conferring with LungNET and other NET patients seeing Dr. Eric Liu and Dr. Allen Cohn.Read More
Advanced Accelerator Applications has received US Food and Drug Administration (FDA) approval of its new drug application for LUTATHERA® (lutetium Lu 177 dotatate) for the treatment of somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults. LUTATHERA® is the first available FDA-approved Peptide Receptor Radionuclide Therapy (PRRT), a form of targeted treatment comprising a targeting molecule that carries a radioactive component. Click here to be taken to a Healing NET NewsFlash with links to more information.
Renowned NET specialist Dr. Dan Granberg, will be available for patient consult with Dr. Eric Liu at Rocky Mountain Cancer Centers in Denver, CO Feb 26-28, 2018, underwritten by a donor advised fund from The Healing NET Foundation.
Appointments can be booked now through Lisa Quesada at Rocky Mountain Cancer Centers. email@example.com 303-388-4876
Background on European Physician Exchange: Many of the treatments now being approved in the U. S. have been in use in Europe for many years. European experts who have been engaged in research and clinical treatment can shorten the learning curve for North American physicians through ongoing mentoring, speaking at meetings, and consultations with patients. The European Physician Exchange program is underwritten through a donor advised fund by the Healing NET Foundation (HNF) and is currently offered at the Rocky Mountain Cancer Centers in Denver, CO. HNF sponsored Dr. Kjell Oberg in 2016.
Dan Granberg, MD, PhD BIO
Associate Professor, Senior Consultant, Department of Endocrine Oncology
Dr. Granberg is a world-renowned physician and a consultant at the Department of Endocrine Oncology, Uppsala Centre of Excellence for endocrine tumors. He is a leading carcinoid and neuroendocrine cancer specialist and has extensive experience in endocrine oncology. His clinical interests are in endocrine tumors, diagnostic procedures, medical therapy, peptide receptor radionuclide therapy, and radioembolization. His research efforts focus on bronchial carcinoids, thymic carcinoids, and development of new diagnostic and therapeutic methods. He has also given many lectures to medical students, doctors, and patients in Sweden and in other countries. He is responsible for the PRRT program with Lutetium-Octreotate at the Department of Endocrine Oncology. He serves as an honorary reviewer for the Journal of Molecular and Genetic Medicine. In addition, he has published more than 50 peer-reviewed articles and reviews, and is the author of a number of book chapters on bronchial carcinoids and NETs. He is currently involved in several research projects in the field of NETs, and is the principal investigator in several clinical trials.
Eric Liu was recently honored at the NCAN (Neuroendocrine Cancer Awareness Network) Celebration of Life Gala in New York as he received the "Above and Beyond" Award, recognizing his commitment to the care and well-being of NET patients world-wide.
Read Eric Liu's bio HERE on our Board of Director's page.
Who says a NET surgeon/specialist cannot have fun? Especially when there are zebra stripes involved! Click here for photos.
Thanks to Maryann and Bob Wahmann, President and Vice-President of NCAN, for this honor, and for all they do for the NET community.
July 27, 2017, Saint-Genis-Pouilly, France - Advanced Accelerator Applications S.A. (NASDAQ:AAAP) (AAA or the Company), an international specialist in Molecular Nuclear Medicine (MNM), today announced that the resubmission of the New Drug Application (NDA) for investigational drug lutetium Lu 177 dotatate* (Lutathera® ) to the US Food and Drug Administration (FDA) was completed. Click here to read more
The second Healing NET International Summit brought 40 physicians and scientists, 12 nurses/nurse practitioners, 7 patient advocates, and various sponsors and exhibitors from the medical, pharmaceutical, and nonprofit community together in Beaver Creek, Colorado, on February 21-23. (Click for Dr. Liu's Summit video and photo gallery)
The topic was Unmet Needs, which is an all too common topic when you are discussing a rare disease many physicians don’t understand; much less the patients seeking or receiving a diagnosis. When all of the participants were asked in advance to identify what they perceived as “unmet needs”, the list was a long one. Below are the categories identified by the group.
General sessions with all participants focused on candid discussion about which unmet needs were the top priority and what solutions might make a difference. Breakout sessions with the physicians ranged from discussing treatment pathways in real patient cases to debating the timing and dosimetry of PRRT. The nurse track focused on practical applications in the clinic to help hear and understand the patient’s real-life experience with carcinoid syndrome, and the patient advocacy representatives focused on ways they might work together to provide the best possible support to patients and caregivers.
A walk-through exhibit allowed attendees to HEAR patient voices describe their carcinoid syndrome experience in their own words and one dinner program was devoted to the clinical trial results of telotristat ethyl (now Xermelo for carcinoid syndrome approved by FDA just days after the Summit ended). A UCLA team presented the real-life experience of their PRRT clinical trial program with perspectives from the patient (Skyped in) and from the physicians, nurses, and even the nuclear safety engineer.
We look forward to providing more details of the Summit, and progress on distribution of results to the medical community. We thank our Summit supporters: Advanced Accelerator Applications, Lexicon, Novartis, Ethicon, Halyard, Neuroendocrine Cancer Awareness Network, Angiodynamics, Biotheranostics, and supported in part by an educational grant from Ipsen.
FOR IMMEDIATE RELEASE FDA APPROVES LEXICON DRUG XERMELO™ (TELOTRISTAT ETHYL) 250 MG AS FIRST AND ONLY ORAL TREATMENT FOR CARCINOID SYNDROME DIARRHEA IN CANCER PATIENTS WITH METASTATIC NEUROENDOCRINE TUMORS First-In-Class: Tryptophan Hydroxylase Inhibitor Orphan Drug XERMELO Now Available to Treat Rare and Debilitating Condition Characterized by Frequent, Severe Diarrhea Conference Call and Webcast at 5:00 pm Eastern Time The Woodlands, Texas, February 28, 2017 – Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced today that the U.S. Food and Drug Administration (FDA) has approved XERMELO™ (telotristat ethyl) 250 mg as a first and only orally administered therapy for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapyi. Carcinoid syndrome is a rare and debilitating condition that affects people with metastatic neuroendocrine tumors (mNETs)ii. XERMELO targets the overproduction of serotonin inside mNET cellsiii, providing a new treatment option for patients suffering from carcinoid syndrome diarrhea. This new treatment is now available by prescription and will be in select specialty pharmacies beginning March 6, 2017. “Today’s approval of XERMELO represents a shift in the treatment paradigm of carcinoid syndrome diarrhea for cancer patients who are inadequately controlled by SSA therapy, and until now, have had limited options to manage this debilitating condition,” said Lonnel Coats, Lexicon’s president and chief executive officer. “We are proud to have discovered and developed this ground-breaking orphan drug, and it is an honor to make it available for the thousands of patients currently suffering from this condition who wish to lead a more routine life with fewer incidences of severe diarrhea.” Carcinoid syndrome is a rare condition that occurs in patients living with mNETsiv and is characterized by frequent and debilitating diarrhea that often prevents patients from leading active, predictable lives, as well as by facial flushing, abdominal pain, fatigue and, over time, heart valve damage. “The approval of XERMELO establishes a new treatment option for patients with carcinoid syndrome diarrhea that is inadequately controlled by SSA therapy,” said Matthew H. Kulke, M.D., TELESTAR primary investigator, director of the Program in Neuroendocrine and Carcinoid Tumors at Dana Farber Cancer Institute and Professor of Medicine, Harvard Medical School. “Inhibition of tumoral serotonin production represents a novel approach for patients with this condition. Studies have shown that XERMELO can reduce the debilitating effects of carcinoid syndrome diarrhea and has a favorable efficacy and safety profile in patients who currently have limited treatment options.” Page 2 About XERMELO™ Discovered using Lexicon’s unique approach to gene science, XERMELO is the first and only approved oral therapy for carcinoid syndrome diarrhea. XERMELO targets tryptophan hydroxylase, an enzyme that mediates the excess serotonin production within mNET cells. Lexicon has built the in-house capability and infrastructure to launch and market XERMELO in the U.S., where it retains all commercialization rights. Lexicon also retains rights to market telotristat ethyl in Japan. Lexicon has established a license and collaboration agreement with Ipsen to commercialize telotristat ethyl in Europe and other countries outside of U.S. and Japan. For more information about XERMELO, please visit www.xermelo.com. XERMELO™ Important Safety Information Warnings and Precautions: XERMELO may cause constipation which can be serious. Monitor for signs and symptoms of constipation and/or severe, persistent, or worsening abdominal pain in patients taking XERMELO. Discontinue XERMELO if severe constipation or severe persistent or worsening abdominal pain develops. Adverse Reactions: The most common adverse reactions (≥5%) include nausea, headache, increased GGT, depression, peripheral edema, flatulence, decreased appetite, and pyrexia. Drug Interactions: If necessary, consider increasing the dose of concomitant CYP3A4 substrates, as XERMELO may decrease their systemic exposure. For more information about XERMELO, see Full Prescribing Information at www.xermelo.com.
About Lexicon Lexicon is a fully integrated biopharmaceutical company that is applying a unique approach to gene science based on Nobel Prize-winning technology to discover and develop precise medicines for patients with serious, chronic conditions. Through its Genome5000™ program, Lexicon scientists have studied the role and function of nearly 5,000 genes over the last 20 years and have identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to safely and effectively treat disease. In addition to XERMELO, Lexicon has a pipeline of promising drug candidates in clinical and preclinical development in diabetes and metabolism and neuropathic pain. For additional information please visit www.lexpharma.com. In an effort to ensure all appropriate patients have fast access to affordable treatment, Lexicon offers LexCares—a comprehensive program designed to guide patients through each step of their treatment journey. Through LexCares, patients will have access to financial assistance programs that may reduce or eliminate out-of-pocket costs associated with their XERMELO prescription. For additional information about the LexCares program, visit www.xermelo.com/lexcares. Page 3 Safe Harbor Statement This press release contains “forward‑looking statements,” including statements relating to the safety and efficacy and the therapeutic and commercial potential of XERMELO (telotristat ethyl) 250 mg. In addition, this press release also contains forward looking statements relating to Lexicon’s growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward‑looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including the degree of market acceptance of XERMELO, the availability of coverage and reimbursement for XERMELO, Lexicon’s dependence on third parties for manufacturing and distribution of XERMELO, Lexicon’s compliance with applicable legal and regulatory requirements and other factors relating to the commercialization of XERMELO. Other risks include Lexicon’s ability to meet its capital requirements, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of its other potential drug candidates, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward‑looking statements. Information identifying such important factors is contained under “Risk Factors” in Lexicon’s annual report on Form 10‑K for the year ended December 31, 2015, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward‑looking statements, whether as a result of new information, future events or otherwise.
For Additional Information Contact: Investors Chas Schultz Senior Director, Finance and Communications (281) 863-3421 firstname.lastname@example.org Media Lori Rodney Vice President GCI Health (212) 798-9915 email@example.com i Data on file – XERMELO label. Lexicon Pharmaceuticals, Inc. 2017. ii National Organization for Rare Disorders. Carcinoid Syndrome. Retrieved from: https://rarediseases.org/rare-diseases/carcinoid-syndrome/. Accessed November 22, 2016. iii Data on file. Lexicon Pharmaceuticals, Inc. 2017. iv Rorstad O. Prognostic indicators for carcinoid neuroendocrine tumors of the gastrointestinal tract. J Surg Oncol. 2005; 89(3):151-60.
BEAVER CREEK, CO - (Wednesday, February 15, 2017) – Top neuroendocrine cancer doctors, nurses, and specialists from around the world will attend the second annual International Healing NET Foundation Summit from February 21-23 in Beaver Creek, CO, it was announced today by Cindy Lovelace, executive director of the Healing NET Foundation (HNF). This marks the Summit’s second year in Beaver Creek, hosting more than 60 faculty members and addressing unmet needs of the neuroendocrine tumor (NET) community.Read More
HNF Executive Director Cindy Lovelace was excited to see the large attendance of physicians and other health care professionals during several NET cancer and carcinoid syndrome presentations at the Gastrointestinal Cancer Symposium in San Francisco presented by American Society of Clinical Oncology (ASCO). The Gastrointestinal (GI) Cancers Symposium is a specialized oncology event designed to provide scientific and educational content for members of the GI cancer care and research community. The symposium offered sessions on Imaging and Therapy of Neuroendocrine Tumors (NETSPOT, LU 177, and Telotristat), Practical Applications of Emerging Treatment Options, and the Treatment Algorithm for Carcinoid Syndrome, among others. HNF SAC member Dr. George Fisher, and HNF SAC and Board member Dr. Thomas O'Dorisio, were part of the sessions.
Check out these videos and pictures below that re-cap presentations specifically on NET Cancer at the ASCO GI 2017. Gallium 68 Scan Become Standard for Staging Neuroendocrine Tumors, Gallium 68 versus Low Volume PRRT, Should Gallium 68 be Used Instead of Ultra Scan, and Gallium 68 Provides Much More Data to Refine Treatment Options 1]: http://www.oncologytube.com/v/10000683/gallium-68-versus-low-volume-prrt
First picture: Dr. Jonathan Strosberg, Moffitt Cancer Center, presents information on new Lu 177 Dotatate therapy pending approval by FDA, at ASCO GI 2017. Dr. Strosberg's NETTER III trial results on the therapy were recently published in New England Journal of Medicine. Second picture: Dr. Emily Bergsland, UCSF, is part of the panel discussion "Neuroendocrine Tumors--Practical Applications of Emerging Treatment Options" moderated by Dr. George Fisher, Stanford. This slide features the Telestar trial for a new carcinoid syndrome drug, Telotristat, currently pending FDA approval. Third picture: L-R NET survivor and Executive Director of Los Angeles Carcinoid Neuroendocrine Tumor Society Giovannna Imbesi and HNF Chief Medical Advisor Dr. Eric Liu listen to insights provided by NET survivor Richard "Spike" Redding, Board member of NorCal CarciNETS group.
A new therapy in development for the treatment of midgut neuroendocrine tumors, a rare type of cancer that occurs in the small intestine and colon, shows improved progression-free survival and response rates for patients with advanced disease. Results of the international phase 3 clinical trial of lutetium-177 (177Lu)-Dotatate compared to high-dose octreotide LAR were published in the Jan. 12 issue of the New England Journal of Medicine.
Saint-Genis-Pouilly, France – January 12, 2017 – Advanced Accelerator Applications S.A. (NASDAQ:AAAP) (“AAA” or “the Company”), an international specialist in Molecular Nuclear Medicine (MNM), today announced that the New England Journal of Medicine published the results of the NETTER-1 Phase III study evaluating efficacy and safety of Lutathera® (lutetium-177 dotatate), an investigational drug, in patients with advanced, progressive somatostatin receptor-positive midgut neuroendocrine tumors (“NETs”).
CONQUER: The Patient Voice™ magazine in partnership with the Academy of Oncology of Nurse & Patient Navigators® (AONN) is proud to announce our very own Healing NET Foundation Executive Director and survivor, Cindy Lovelace as a 2016 finalist for Hero of Hope ™ Patient Award.
Cindy has shown extraordinary commitments to the NET community fundraising and hierarchical authority. Cindy Lovelace serves as a good example to other individuals with NET or any form of malignancy. Hero of Hope is sending the 6 leading nominees to the Seventh Annual AONN+ Conference in Las Vegas, Nevada. The winner of the Hero of Hope Award will be declared at the conference and get a plaque perceiving their commitments to the cancer community and also a gift of $1,000 made to their preferred philanthropy in their name.
Listen to Cindy's storyAfter being diagnosed with a rare cancer, Cindy started the Healing NET Foundation. This not-for-profit organization is dedicated to giving more resources to physicians who are treating neuroendocrine tumors.
Detailed results from Lexicon’s pivotal Phase 3 TELESTAR clinical study of telotristat ethyl in patients with carcinoid syndrome have been published. The article titled “Telotristat Ethyl, a Tryptophan Hydroxylase Inhibitor for the Treatment of Carcinoid Syndrome” is available online at the Journal of Clinical Oncology website at ascopubs.org/journal/jco.
TELESTAR was a global double-blind Phase 3 study which enrolled 135 patients from 12 countries with carcinoid syndrome whose symptoms were not adequately controlled on somatostatin analog therapy (SSA), the current standard of care. Data show that patients who added telotristat ethyl to SSA therapy at both the 250 mg and 500 mg doses experienced a statistically significant reduction from baseline compared to placebo in the average number of daily bowel movements over the 12-week study period (p<0.001), data-preserve-html-node="true" meeting the study’s primary endpoint. There was also a statistically significant reduction in the levels of urinary 5-hydroxyindole acetic acid (5-HIAA), the main metabolite of serotonin, from baseline to week 12 with a reduction of 40 mg/24 hours (250 mg arm) and 58 mg/24 hours (500 mg arm) versus an increase of 11 mg/24 hours in the placebo arm (p<0.001). data-preserve-html-node="true" Treatment with telotristat ethyl was generally well tolerated during the double-blind treatment period.
Eighty-five percent of the patients originally enrolled in TELESTAR opted to continue study participation, receiving treatment with 500 mg telotristat ethyl in a 36-week open-label extension (OLE) study. Results from the OLE showed sustained bowel movement responses to treatment and no additional safety signals. Additional results detailed in the publication showed evidence that telotristat ethyl may also improve stool consistency, reduce the urgency to defecate and reduce the use of rescue short-acting octreotide. The Lexicon clinical development team, headed by Chief Medical Officer Pablo Lapuerta, is “very encouraged about the potential benefits telotristat ethyl may bring in terms of bowel movement frequency and other measures of carcinoid syndrome severity.” Telotristat ethyl has received Fast Track and Orphan Drug designation from the U.S. Food and Drug Administration and has been granted priority review by the FDA with a Prescription Drug User Fee Act (PDUFA) target action date of February 28, 2017. If approved by the FDA, telotristat will be the first new treatment for carcinoid syndrome in more than ten years.
Advanced Accelerator Applications U.S. facility where Lutathera (PRRT) will be manufactured for clinical use in North America. FDA approval is anticipated by the end of the year. The facility is impressive from state of the art equipment to it's over the top standards and security, and the people are just as awesome. If you are confused about the current status of nuclear medicine scans and treatments for NET cancer in the U. S., please click through to the HNF Zebra Blog by Dr. Eric Liu about Netspot (Ga 68 diagnostic scan kit), which was just approved by FDA, and click on the link in the blog to better understand Lutathera. From Cindy Lovelace, HNF Exec Dir and PNET.