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University Hospitals Seidman Cancer Center becomes first in U.S. to use newly FDA-approved imaging agent that makes brain tumors glow hot pink

On October 12, 2018 The imaging agent 5-Aminolevulinic Acid (5-ALA), which helps neurosurgeons see the edges of a tumor more clearly to improve removal, was used in brain cancer surgery at University Hospitals Seidman Cancer Center today for the first time since the FDA approved it for use in the United States (Press release, University Hospitals, OCT 12, 2018, View Source [SID1234530230]). Although the drug has long been a standard of care in Germany and much of Europe, it was only approved by the FDA for use in the U.S. in 2017.

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Andrew Sloan, MD, Director, Brain Tumor and Neuro-Oncology Center at UH Seidman and UH Cleveland Medical Center, who has been doing clinical trials with the drug for almost a decade based on his own FDA-approved IND clinical trial, was the first neurosurgeon in the U.S. to use the drug on a patient with brain cancer since FDA approval.

Several published studies — including those from Dr. Sloan — have shown that removing more tumor results in improved survival. However, this often is difficult.

"Glioblastoma are tumors which derive from the brain itself. They look like brain tissue, they feel like brain tissue, and at times, it’s hard to determine where tumor ends and inflamed brain tissue begins," said Dr. Sloan.

To help identify the difference between the border of tumors and healthy tissue and improve tumor removal, Dr. Sloan used 5-ALA during surgery so that the tumor cells glowed hot pink when illuminated with a special blue light incorporated into his operating microscope.

This novel technique enabled him to see the edges of the tumors more clearly, allowing him to remove them more completely from the brain.

Sutro’s STRO-001 Receives U.S. FDA Orphan Drug Designation for Treatment of Multiple Myeloma

On October 12, 2018 Sutro Biopharma, Inc. (NASDAQ: STRO), reported that it has been granted Orphan Drug Designation by the United States Food and Drug Administration (FDA) for STRO-001 for the treatment of multiple myeloma (Press release, Sutro Biopharma, OCT 12, 2018, View Source [SID1234529894]). STRO-001 is a potential first-in-class antibody drug conjugate (ADC) targeting CD74, a protein highly expressed in B-cell malignancies such as multiple myeloma.

"There is a growing need for new treatment options for patients with multiple myeloma," commented Bill Newell, Sutro’s Chief Executive Officer. "This Orphan Drug Designation is a great step towards advancing our uniquely designed STRO-001 that could bring new treatment options to patients in need."

STRO-001 was developed with Sutro’s proprietary cell-free protein synthesis and site-specific conjugation platform, XpressCF+, which facilitate precision design and rapid empirical optimization of ADCs. Sutro’s technology enables design and manufacture of a highly optimized single molecular species within the product, rather than the usual mixture of imprecisely conjugated antibodies that comprise an ADC development product made by conventional cell-based manufacturing platforms.

"STRO-001 was designed to directly target cancer cells to deliver a cytotoxic payload. Building upon our XpressCF+ platform we plan to develop better options to treat tumors with greater precision," Bill Newell added.

STRO-001 is currently being studied in a Phase 1 clinical trial enrolling separate dose escalation cohorts for myeloma and B-cell lymphoma.

About Orphan Drug Designation

The Orphan Drug Designation Program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug.

AIVITA Biomedical Attains Japanese PMDA Milestone for ROOT OF CANCER Technology

On October 12, 2018 AIVITA Biomedical reported the successful completion of the manufacturing quality consultation and clinical safety consultation for its patient-specific cancer immunotherapy with the Japanese regulatory agency, Pharmaceutical and Medical Devices Agency (PMDA) (Press release, AIVITA Biomedical, OCT 12, 2018, View Source [SID1234529893]). PMDA approval allows AIVITA to move forward to the final round of discussions focused on the clinical protocol, in the Company’s efforts to obtain conditional approval to market their product in Japan.

"Japan’s regenerative medicine clinical approval process is the most advanced in the world, allowing expedited commercialization of stem cell-based technologies," said Dr. Hans S. Keirstead, Chairman and CEO of AIVITA Biomedical. "Their manufacturing and safety approval is a highly qualified validation of our ROOT OF CANCER program."

AIVITA’s treatment consists of autologous dendritic cells loaded with autologous antigens from the patient’s tumor-initiating cells. Previously, this treatment was tested in two Phase 2 trials in patients with advanced melanoma and approved for Phase 3 testing. The first Phase 2 trial demonstrated a 72% 2-year survival rate and a 54% 5-year survival rate. The second randomized Phase 2 trial demonstrated similar results, with a significantly longer median survival compared to the control arm.

AIVITA’s ROOT OF CANCER technology is also the subject of two ongoing Phase 2 trials, in patients with advanced ovarian cancer and in patients with newly diagnosed glioblastoma in the USA.

About ROOT OF CANCER

AIVITA’s treatment is a platform technology applicable to most solid tumor types and consists of autologous dendritic cells loaded with autologous tumor antigens from autologous self-renewing tumor-initiating cells.

AIVITA’s ovarian Phase 2 double-blind study is active and enrolling approximately 99 patients who will be randomized in a 2:1 ratio to receive either the autologous dendritic cell vaccine or autologous monocytes as a comparator.

Patients eligible for randomization and treatment will be those (1) who have undergone debulking surgery, (2) for whom a cell line has been established, (3) who have undergone leukapheresis from which sufficient monocytes were obtained, (4) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), and (5) who have completed primary therapy.

For additional information about AIVITA’s AVOVA-1 trial patients can visit www.clinicaltrials.gov/ct2/show/NCT02033616

AIVITA’s glioblastoma Phase 2 single-arm study is active and will enroll approximately 55 patients to receive the treatment candidate.

Patients eligible for treatment will be those (1) who have recovered from surgery such that they are about to begin concurrent chemotherapy and radiation therapy (CT/RT), (2) for whom an autologous tumor cell line has been established, (3) have a Karnofsky Performance Status of > 70 and (4) have undergone successful leukapheresis from which peripheral blood mononuclear cells (PBMC) were obtained that can be used to generate dendritic cells (DC).

Bausch Health Companies Inc. Will Release Third-Quarter 2018 Financial Results On November 6

On October 12, 2018 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health") reported that it will release its third-quarter 2018 financial results on Tuesday, Nov. 6, 2018 (Press release, Valeant, OCT 12, 2018, View Source [SID1234529891]). Bausch Health will host a conference call and live web cast at 8:00 a.m. EST to discuss the results and provide a business update. All materials will be made available on the Investor Relations section of the Bausch Health website prior to the start of the call.

Conference Call Details

Date:

Tuesday, Nov. 6, 2018

Time:

8:00 a.m. EST

Webcast:

View Source

Participant Event Dial-in:

+1 (888) 317-6003 (United States)

+1 (412) 317-6061 (International)

+1 (866) 284-3684 (Canada)

Participant Passcode:

4973686

Replay Dial-in:

+1 (877) 344-7529 (North America)

+1 (412) 317-0088 (International)

+1 (855) 669-9658 (Canada)

Replay Passcode:

10125383 (replay available until Nov. 13, 2018)

Ipsen to present new data from its oncology portfolio at the 2018 European Society for Medical Oncology (ESMO) congress

On October 12, 2018 Ipsen (Euronext: IPN; ADR: IPSEY) reported that cabozantinib (Cabometyx), irinotecan liposome injection (Onivyde), lanreotide (Somatuline) and the combination of lanreotide and telotristat (Xermelo) are the subject of 12 presentations at the 2018 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) annual congress (Press release, Ipsen, OCT 12, 2018, View Source [SID1234529884]). The meeting takes place in Munich, Germany, October 19-23, 2018.

"Ipsen has had a momentous 12 months since ESMO (Free ESMO Whitepaper) 2017, particularly with the positive regulatory milestones achieved for Cabometyx in renal cell and hepatocellular carcinoma, and for Xermelo in neuroendocrine tumours. Our story continues with a strong presence at ESMO (Free ESMO Whitepaper) 2018 with 12 posters presenting meaningful data for patients with hepatocellular carcinoma, renal cell carcinoma, medullary thyroid cancer, pancreatic cancer and neuroendocrine tumours," said Alexandre Lebeaut M.D, Executive Vice President, Research & Development and Chief Scientific Officer, Ipsen.

"Our oncology products, notably Cabometyx, Onivyde, Somatuline and Xermelo have been evaluated by scientific teams around the world; either directly by investigators, by our partners, or by Ipsen, and results from some of these investigations will be shared at ESMO (Free ESMO Whitepaper) 2018. We are committed in our efforts against cancer, and through our interactions at ESMO (Free ESMO Whitepaper) will continue to advance innovation for patient care in oncology", added Dr Lebeaut.

Cabozantinib (Cabometyx) will be featured in 5 posters:

Poster session, Sunday October 21st, 13:15 ‐ 14:15, Hall A3

CELESTIAL study

[Poster 702P] Outcomes by baseline alpha-fetoprotein (AFP) levels in the phase 3 CELESTIAL trial of cabozantinib (C) versus placebo (P) in previously treated advanced hepatocellular carcinoma (HCC) (Kelley et al.)
Presenting author: R.K. Kelley [Sponsor: Exelixis]

[Poster 703P] Assessment of disease burden in the phase 3 CELESTIAL trial of cabozantinib (C) versus placebo (P) in advanced hepatocellular carcinoma (HCC) (Blanc et al.)
Presenting author: JF Blanc [Sponsor: Exelixis]

[Poster 704P] Outcomes by prior transarterial chemoembolization (TACE) in the phase 3 CELESTIAL trial of cabozantinib (C) versus placebo (P) in patients (pts) with advanced hepatocellular carcinoma (HCC) (Yau et al.)
Presenting author: T Yau [Sponsor: Exelixis]

Poster session, Monday October 22nd, 13:15 ‐ 14:15, Hall A3

COSMIC-021 study (Cabozantinib + atezolizumab)

[Poster 872P] Phase 1b study (COSMIC-021) of cabozantinib in combination with atezolizumab in solid tumors: Results of the dose escalation stage in patients with treatment-naïve advanced RCC (Agarwal et al.)
Presenting author: N Agarwal [Sponsor: Exelixis]

Poster session, Sunday October 21st, 13:15 ‐ 14:15, Hall A3

EXAMINER study

[Poster 129TiP] A noninferiority trial of cabozantinib (C) comparing 140 mg vs 60 mg orally per day to evaluate the efficacy and safety in patients (pts) with progressive, metastatic medullary thyroid cancer (MTC) (Krajewska et al.)
Presenting author: J Krajewska [Sponsor: Exelixis]

Poster session, Sunday October 21st, 13:15 ‐ 14:15, Hall A3

Irinotecan liposome injection (Onivyde) will be featured in 4 presentations:

[Poster 749P] The prognostic value of the Modified Glasgow Prognostic Score (mGPS) in predicting overall survival (OS) in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) receiving liposomal irinotecan (nal-IRI)+5-fluorouracil and leucovorin (5-FU/LV). (Chen, et al.)
Presenting author: L-T Chen [Sponsor: Ipsen]

[Poster 734P] Impact of dose reduction or dose delay on the efficacy of liposomal irinotecan (nal-IRI)+5-fluorouracil/leucovorin (5-FU/LV): Survival analysis from NAPOLI-1. (Chen, et al.)
Presenting author: L-T Chen [Sponsor: Ipsen]

[Poster 735P] Real-world dosing patterns of patients (pts) with metastatic pancreatic cancer (mPC) treated with liposomal irinotecan (nal-IRI) in US oncology clinics. (Ahn, et al.)
Presenting author: D Ahn [Sponsor: Ipsen]

[Poster 733P] NAPOLI-1 Phase 3 trial outcomes by prior surgery, and disease stage, in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC). (Macarulla, et al.)
Presenting author: T Macarulla [Sponsor: Shire]

Poster session, Sunday October 21st, 13:15 ‐ 14:15, Hall A3

Lanreotide (Somatuline) will be featured in 2 presentations:

PRELUDE (TGR)

[Poster 1331P] Tumour growth rate (TGR) when using lanreotide Autogel (LAN) before, during and after peptide receptor radionuclide therapy (PRRT) in advanced neuroendocrine tumours (NETs). (Prasad, et al.)
Presenting author: V Prasad [Sponsor: Ipsen]

Poster session, Sunday October 21st, 13:15 ‐ 14:15, Hall A3

CLARINET (diabetes)

[Poster 1319P] Post-hoc analysis of CLARINET phase III study to investigate the influence of diabetic status on progression-free survival (PFS) of patients with neuroendocrine tumours (NETs) treated with lanreotide (LAN) or placebo (PBO). (Pusceddu, et al.)
Presenting author: V Pusceddu [Sponsor: Ipsen]

Poster session, Sunday October 21st, 13:15 ‐ 14:15, Hall A3

Lanreotide (Somatuline) & telotristat (Xermelo) will be featured in 1 presentation:

TELESTAR & TELECAST (LAN patients)

[Poster 4378P] Efficacy and safety of telotristat ethyl (TE) in combination with lanreotide (LAN) in patients with a neuroendocrine tumour and carcinoid syndrome (CS) diarrhoea (CSD): Meta-analysis of phase 3 double-blind placebo (PBO)-controlled TELESTAR and TELECAST studies. (Hörsch, et al.)