Based on Animal Studies, Bayer Halts Enrolling Uterine Fibroid Human Trial

Frankfurt, Germany-based Bayer reported that it had halted enrollment in a clinical trial of its vilaprisan for uterine fibroids.

In July 2017, Bayer launched a three-year, Phase III ASTEROID clinical trial of vilaprisan in patients with symptomatic uterine fibroids, with the intention of recruiting more than 3,600 patients in 900 sites in 40 countries.

Uterine fibroids are common but benign gynecological tumors. Vilaprisan is an oral progestin and selective progesterone receptor modulator (SPRM) with potential anti-progesterone and antineoplastic activities. The drug competitively binds to the progesterone receptor (PR) in progesterone-responsive tissue and inhibits PR-mediated gene expression, which interferes with progesterone activity in the reproductive system.

Bayer indicates that they are halting enrollment in the trials, not because of safety signals found during the trial, but issues observed in ongoing analysis in long-term toxicology studies.

Joerg Moeller, head of Bayer’s drug development, stated, “For vilaprisan we have just some days ago put clinical development of our ongoing trials on hold,” reported Reuters. “That is due to very recent safety findings in long-term toxicology studies…. We have therefore decided as a precautionary measure to stop enrollment into our ongoing program and evaluate the data.”

The toxicology studies were from pre-clinical testing on rodents, which is being carried out in parallel to the Phase III trials.

The company indicated that findings in the preclinical studies haven’t been seen in the human trials, but they were being cautious and pausing recruitment until they could conduct a more thorough analysis. Patients currently in the trials will continue their treatment according to the study protocol.

The drug, if approved, has been projected to generate peak annual sales of more than $1.1 billion. About 5 to 10 percent of women require treatment for uterine fibroids.

It can be a tough disease to treat with drugs, however. In August 2018, the U.S. Food and Drug Administration (FDA) rejected Allergan’s New Drug Application (NDA) for ulipristal acetate for abnormal bleeding from uterine fibroids. The FDA issued a Complete Response Letter, citing safety concerns over post-marketing reports outside of the U.S.

The drug was approved in Europe under the brand name Esmya, but there were reports that the drug led to liver damage in some patients. Although the European Medicines Agency (EMA) didn’t pull the drug off the market, after a three-month investigation, it issued new guidelines to minimize the risk of liver damage. That included noting the drug was contraindicated in women with known liver problems, and recommended liver tests before, during and after treatment with the drug.

In July, the FDA approved AbbVie’s Orilissa (elagolix) for moderate to severe endometriosis pain. Orlissa is an oral nonpeptide small molecule gonadotrophin-release hormone (GnRH) receptor antagonist that inhibits endogenous GnRH signaling. In August, the drug showed positive topline results in the Phase III ELARIS UF-EXTEND extension trial for uterine fibroids.

In combination with low-dose hormone therapy, the drug reduced heavy menstrual bleeding in 87.9 percent of women with uterine fibroids. This was consistent with two previous Phase III trials. The safety profile was consistent with the previous data, as well. Most frequent adverse events were hot flush, night sweats, nausea, headache and nasopharyngitis, as well as reduced bone mineral density. AbbVie expects to submit the drug for approval for uterine fibroids in 2019.

https://www.biospace.com/article/bayer-halts-enrollment-in-uterine-fibroids-trial/

Acceleron: Luspatercept Phase 3 Presentations Selected for “Best of ASH”

Acceleron Pharma Inc. (Nasdaq:XLRN) today announced that the presentations of the MEDALIST and BELIEVE Phase 3 trial results of luspatercept in patients with lower-risk myelodysplastic syndromes (MDS) and beta-thalassemia associated anemias, respectively, were selected for “Best of ASH” by the American Society of Hematology at its 60^th Annual Meeting & Exposition in San Diego. Luspatercept is an investigational therapy that is part of a global collaboration between Acceleron and Celgene.

The Society describes its “Best of ASH” selections, chosen from among the thousands of meeting abstracts, as “the biggest breakthroughs from the meeting’s scientific presentations.”

“Having both the MEDALIST and BELIEVE trials included in the Best of ASH session at the close of the annual meeting is extraordinarily gratifying,” said Habib Dable, President and Chief Executive Officer of Acceleron. “Throughout its development, luspatercept has demonstrated promising results in patients with these two distinct diseases associated with anemia. Yesterday’s event is a clear indication that the global hematology community recognizes the potential clinical impact of luspatercept.”

https://www.marketscreener.com/ACCELERON-PHARMA-INC-14297719/news/Acceleron-Pharma-Announces-Luspatercept-Phase-3-MEDALIST-and-BELIEVE-Presentations-Selected-for-l-27711973/

Supernus Call to Present Topline Results of Two Phase 3 ADHD Studies

Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases, today announced that, on Thursday, December 6, 2018, at approximately 7:00 a.m. ET, it will issue a press release announcing the results of its two Phase III studies for SPN-812 in patients 6-11 years old, for the treatment of attention deficit hyperactivity disorder (ADHD).

Supernus will hold a conference call and webcast on Thursday, December 6, 2018, at 9:00 a.m. ET to discuss the topline results of the clinical trials. Presentation slides will be made available approximately 30 minutes prior to the call. The call will be hosted by Jack Khattar, President and Chief Executive Officer; Stefan Schwabe, Chief Medical Officer and Executive Vice President of Research & Development; and Greg Patrick, Vice President and Chief Financial Officer.

Conference Call Details

Presentation slides will be available via this webcast link approximately 30 minutes prior to the conference and webcast. A question and answer session with the Supernus management team will follow the Company’s remarks.

Please refer to the information below for conference call dial-in information and webcast registration. Callers should dial in approximately 10 minutes prior to the start of the call.

Conference dial-in:	(877) 288-1043
International dial-in:	(970) 315-0267
Conference ID:	8685367
Conference Call Name:	Supernus Pharmaceuticals SPN-812 Phase III Topline Results
Webcast link:	Click here

Following the live call, a replay will be available on the company’s website, www.supernus.com, under ‘Investors’.

https://www.marketscreener.com/SUPERNUS-PHARMACEUTICALS-10523839/news/Supernus-Schedules-Conference-Call-to-Present-Topline-Results-of-Two-Phase-III-Studies-for-SPN-812-i-27711924/

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AbbVie Phase 3 Lung Cancer Med Trial Halted

AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced the decision to stop enrollment for the TAHOE trial, a Phase 3 study evaluating Rovalpituzumab Tesirine (Rova-T) as a second-line therapy for advanced small-cell lung cancer (SCLC). An Independent Data Monitoring Committee (IDMC) recommended stopping enrollment in TAHOE due to shorter overall survival in the Rova-T arm compared with the topotecan control arm. For patients currently on treatment with Rova-T in TAHOE, the IDMC recommended that investigators and patients make individual decisions as to whether or not to continue treatment based on patient level response. The recommendation from the IDMC to halt enrollment applies only to the TAHOE study and does not impact other Rova-T clinical studies.

“Patients are our first priority and we are deeply grateful to the patients and physicians who participated in this trial,” said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. “We remain committed to discovering and developing transformative therapies for people living with cancer.”

The TAHOE trial is a randomized, open-label, two-arm, Phase 3 trial assessing the efficacy, safety and tolerability of Rova-T versus topotecan in participants with advanced or metastatic small-cell lung cancer (SCLC) with high levels of delta-like protein 3 (DLL3) and who have first disease progression during or following front-line platinum-based chemotherapy.

https://www.marketscreener.com/ABBVIE-12136589/news/AbbVie-Phase-3-Trial-of-Rova-T-as-Second-line-Therapy-for-Advanced-Small-Cell-Lung-Cancer-TAHOE-S-27711885/

Inovio Starts ‘MD Anderson’s HPV-Related Cancers Moon Shot’ Phase 2 Trial

Inovio Pharmaceuticals, Inc. (NASDAQ: INO) announced today the dosing of the first patient in a Phase 2 combination trial to evaluate MedImmune’s MEDI0457 (formerly called INO-3112 which MedImmune in-licensed from Inovio) in combination with durvalumab targeting a broad array of cancers associated with the human papilloma virus (HPV).

This open-label trial funded by MedImmune, the global biologics research and development arm of AstraZeneca, is sponsored by noted cancer researcher Dr. Michael Frumovitz, MD, MPH, of the MD Anderson Cancer Center in Houston, Texas, where the trial will be conducted as part of MD Anderson’s ‘Moon Shot’ cancer initiative. MedImmune is evaluating MEDI0457 in combination with durvalumab, an anti-PD-L1 immune checkpoint inhibitor, in patients with HPV-associated cervical, anal, penile, and vulvar cancers in arms of a clinical trial with an estimated total enrollment of 77 patients.

The opening of this trial will result in a milestone payment from MedImmune to Inovio. Financial arrangements were not disclosed.

Dr. Frumovitz said, ‘This is the first Phase 2 clinical trial at MD Anderson that is focused not on the site of disease origin, but instead on the cause of a cancer-in this case exposure to HPV 16 or 18. The HPV Moon Shot at MD Anderson has developed an entire research program with this philosophy in mind – that HPV-associated cancers behave similarly, regardless of site of origin, and should be studied as a whole, not as individual cancers. This study will be ‘site agnostic’, meaning any patient with an HPV 16/18 associated cancer, regardless of primary site, will be eligible. Another truly unique aspect of this study is a separate cohort for patients who are HIV positive with an HPV 16/18 associated cancer.’

Dr. J. Joseph Kim, Inovio’s President and Chief Executive Officer, said, ‘We are pleased to see Inovio’s cancer-fighting immunotherapy, in MEDI0457, expand to new cancer indications. Such expansion is great for patients and the oncology community. For Inovio, amplification of HPV cancer targets holds the potential to bring about additional milestone and royalty payments.’

An article in the online edition of Clinical Cancer Research highlights a recent Phase 1 study of MEDI0457 as a monotherapy in 22 HPV-positive patients with HPV-associated head and neck cancer that demonstrated MEDI0457 generated robust HPV16/18 specific CD8+ T cell responses in peripheral blood and increased CD8+ T cell infiltration in resected tumor tissue. One patient in that trial who initially displayed a slight increase in T cell immune responses developed progressive disease at 11 months into the study and subsequently received a PD-1 checkpoint inhibitor. The patient achieved a complete response, which has sustained for over two years and counting. Increasing evidence suggests that response rates from checkpoint inhibitors can be enhanced when used in combination with cancer vaccines like MEDI0457 that generate tumor-specific T cells.

https://www.marketscreener.com/INOVIO-PHARMACEUTICALS-IN-17937428/news/Inovio-Pharmaceuticals-Announces-Initiation-of-MD-Anderson-s-HPV-Related-Cancers-Moon-Shot-Phase-27710476/

Eisai New Analyses on Long-Term Seizure Freedom Rates with Epilepsy Med

Eisai Inc. presented new data on FYCOMPA (perampanel) CIII at the American Epilepsy Society Annual Meeting in New Orleans which included analyses of convulsive seizure freedom rates in adult and pediatric epilepsy patients.

More than 50 scientific posters on FYCOMPA were presented by both Eisai and independent investigators, underscoring a collective commitment to advancing research in epilepsy care.

Of note, Eisai presented three post-hoc analyses evaluating the potential of FYCOMPA to help patients experience long-term, sustained convulsive seizure freedom, as well as data that supported the recent U.S. Food and Drug Administration (FDA) approval of FYCOMPA for monotherapy and adjunctive use in pediatric patients 4 years and older for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures. Additional data included all-cause and epilepsy-related hospitalizations with use of FYCOMPA compared to lacosamide.

‘These long-term seizure freedom data showed about 53% of patients with secondarily generalized seizures experienced convulsive seizure freedom at 2 years and close to 35% at 3 years,’ said Trevor Resnick, MD, Pediatric Neurologist at Nicklaus Children’s Hospital. ‘These results are very encouraging for patients who are affected by uncontrolled convulsive seizures and for whom seizure freedom remains an important treatment goal.’

FYCOMPA was initially approved for adjunctive use in POS in patients 12 years and older in 2012 and was later approved as adjunctive therapy for PGTC seizures in patients with epilepsy 12 years of age and older, and then as monotherapy for POS with or without secondarily generalized seizures in patients with epilepsy 12 years of age and older. In September 2018, FYCOMPA was approved for monotherapy and adjunctive use in pediatric patients 4 years and older for the treatment of POS with or without secondarily generalized seizures.

‘The broad scope of FYCOMPA data being presented highlights how FYCOMPA may help both children and adults on their journey toward the goal of seizure freedom,’ said Ivan Cheung, Chairman and CEO, Eisai Inc. ‘These data encourage us to continue the important work of conducting research that leads to improved clinical outcomes for these patients.’

To date, FYCOMPA is approved in 55 countries and has been used to treat more than 200,000 patients worldwide across all indications.

https://www.marketscreener.com/EISAI-CO-LTD-6492461/news/Eisai-New-Analyses-Evaluate-Long-Term-Convulsive-Seizure-Freedom-Rates-with-Use-of-Adjunctive-FYCO-27710478/

Unitedhealth Optum Bank Data Tool Uses AI to Help Up Health Savings

• Updated Optum Health Finance Journey model gives employers enhanced strategies to help increase engagement and health savings of employees
• Using AI and advanced analytics is already resulting in higher savings rates, helping people with care affordability

Optum Bank, the nation’s leading provider of heath savings accounts, has enhanced its data and analytics tool to help increase health savings account (HSA) savings and provide accountholders with a better understanding of how to use their HSAs to pay for health care costs.

Optum Bank’s updated Health Finance Journey uses behavioral science and advanced analytics to determine what motivates consumers to behave in certain ways. The Optum model then clusters consumers into microsegments based on common attributes and motivations. This provides employers that sponsor HSA qualifying insurance plans with unique insights that enable them to develop better targeted and personally relevant communications to help employees save more for their health care expenses and make better health care decisions.

This updated model is providing encouraging results. Overall, accountholders who were targeted with new messages based on the enhanced Health Finance Journey increased their balances, became eligible to invest, and took the next step and chose to open investment accounts. Specifically, the enhanced tool resulted in:

• A 26 percent increase in one-time contributions.
• An increase of average balances of 12 percent.
• A 23 percent increase in investment account openings. Most health savings accountholders are required to have a minimum cash balance before they can open an investment account.

“Employers want access to the latest data-driven analytics and tools that help their employees save for their current and future health care needs,” said Deb Culhane, president and CEO of Optum Bank. “The Health Finance Journey’s enhanced capabilities offer employers better strategies to help them communicate the right messages, to the right employees, at the right time. We are very encouraged by the initial results of applying this updated model.”

Optum Bank’s enhanced Health Finance Journey recently used machine learning to analyze nearly 200,000 de-identified accountholders and identified natural segments and clusters. As an outcome of the analytics process, more than 2,000 attributes were synthesized based on inputs such as HSA contributions and distributions, account tenure and consumer behaviors, among others. The final result was 20 microsegments, where a consumer within a specific microsegment can be targeted with specific communications most relevant to them.

In 2014, Optum created the ‘5 Stages of Health Saving and Spending’ to map employee health care saving and spending behavior with HSAs. These are stages that people take in their health savings from deciding to get an HSA to optimizing their accounts through the investment option. The Optum Health Finance Journey works in tandem with the ‘5 Stages’ by providing employers with deeper understanding of where their employees have progressed in each of the stages, and helps employers with targeted communications tactics to move employees through all five stages, thereby increasing engagement and savings rates.

For more information about Health Finance Journey and the ‘5 Stages of Health Saving and Spending,’ visit the Optum Bank website at: https://www.optumbank.com/resources.html.

Investments are not FDIC insured, are not guaranteed by Optum Bank^®, and may lose value.

About Optum Bank
Optum Bank, Member FDIC, and OptumHealth Financial Services (OHFS), is a health and wellness company serving more than 115 million people. Optum Bank is solely dedicated to health care banking with more than 10 years of experience managing health savings accounts (HSAs). With more than 5 million health savings and notional accounts, and more than $9.5 billion in assets, Optum Bank is uniquely positioned to guide consumers along the journey from opening to optimizing an HSA.

https://www.marketscreener.com/UNITEDHEALTH-GROUP-14750/news/Optum-Bank-Data-Tool-Uses-Artificial-Intelligence-Advanced-Analytics-to-Help-People-Increase-Heal-27711080/