DURECT Corporation to Announce First Quarter 2020 Financial Results and Provide Business Update on May 11

On May 4, 2020 DURECT Corporation (Nasdaq: DRRX) reported that it will report first quarter 2020 financial results and host a conference call after the market close on Monday, May 11, 2020 (Press release, DURECT, MAY 4, 2020, https://www.prnewswire.com/news-releases/durect-corporation-to-announce-first-quarter-2020-financial-results-and-provide-business-update-on-may-11-301052306.html [SID1234556972]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Monday May 11th @ 4:30pm Eastern Time / 1:30 p.m. Pacific Time

Toll Free:

877-407-0784

International:

201-689-8560

Conference ID:

13703442

Webcast:

View Source

CEL-SCI’s Pivotal Phase 3 Study Has Reached the Required Number of Events to Evaluate Data for Multikine in Treatment of Head and Neck Cancer

On May 4, 2020 CEL-SCI Corporation (NYSE American: CVM) reported that it has been notified that it has reached the targeted threshold of 298 events (deaths) required to conduct the data evaluation for its pivotal Phase 3 head and neck cancer study of Multikine* (Leukocyte Interleukin, Inj.) immunotherapy (Press release, Cel-Sci, MAY 4, 2020, View Source [SID1234556971]). The database is now being prepared for database lock. Once the database has been locked the final analysis of the trial results can be performed. CEL-SCI will continue to remain blinded to the study results throughout this process. CEL-SCI will be advised of the results when the analysis is completed and the study results will be announced to the public and investors at that time.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The CROs involved in study management are generating the remaining queries, performing source data verification, completing medical review, and building the final database needed to produce the final tables, listings, and figures.

Geert Kersten, Chief Executive of CEL-SCI said, "We have conducted this 928 patient pivotal Phase 3 study for over nine years because we hope to improve the current standard of care for advanced primary head and neck cancer. We believe that the activation of the immune system by Multikine BEFORE the ravages of surgery, radiation and chemotherapy can improve the survival of these patients. I am incredibly proud of the dedication of our amazing team who has made all of this possible."

Clinigen: IL-2 Plays Role in Emerging TIL Therapies

On May 4, 2020 Clinigen Group plc (AIM: CLIN, ‘Clinigen’ or the ‘Group’), the global pharmaceutical and services company reported that presentation of results from the Phase I trial "Durable complete responses to adoptive cell transfer using tumor infiltrating lymphocytes (TIL) in non -small cell lung cancer (NSCLC) (Press release, Clinigen Group, MAY 4, 2020, View Source [SID1234556970])." Ben C. Creelan MD, MS from the Thoracic Oncology, Immunology Program of the Moffitt Cancer and Research Institute presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) virtual annual meeting on April 28, 2020. Eligibility criteria described in trial registry (NCT03215810).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The objectives of the study were to evaluate the safety and efficacy of TIL therapy in metastatic NSCLC (mNSCLC) after evidence of progression on nivolumab*. The authors concluded that the Cy/Flu/TIL/IL-2 therapy has manageable toxicity and sustained activity in PD-1 experienced mNSCLC. It also was speculated that TIL may be a promising therapeutic option for certain mNSCLC patients.

Adoptive cellular therapy is a novel treatment which typically includes select lymphodepleting agents, autologous tumor infiltrating lymphocytes and Proleukin. This therapy currently is being studied in a range of tumors.

Shaun Chilton, Group Chief Executive Officer, Clinigen said:

"We applaud the Moffitt Cancer Center, Dr Creelan and co-investigators on this study and their work looking at this novel treatment in a cancer with such high unmet medical need. At Clinigen, we strive for solutions to improve people’s lives and are pleased with the role Proleukin is playing in the development of these emerging TIL therapies."

– Ends –

Notes to Editors

About TIL therapy

Adoptive cell therapy (ACT) using tumor-infiltrating lymphocytes (TIL) is a personalized cancer treatment based on the infusion of autologous CD4+ and CD8+ T lymphocytes expanded in-vitro from tumors in the presence of interleukin-2 (IL-2) 2 alone, or in combination with IL-7, IL-15, and/or IL-21. 3,4,5 The treatment may include high-dose lymphodepleting chemotherapy, the infusion of the expanded and activated T cells and interleukin-2 (IL-2) injections to increase survival of the T cells. 6 TIL therapy currently is being studied in a wide range of tumors.

About Proleukin

Proleukin is the first and only approved recombinant IL-2 indicated for the treatment of adults with metastatic renal cell carcinoma (mRCC) or metastatic melanoma (mM) by the US Food and Drug Administration (FDA). For further information, specific to the US product dosing and administration please visit www.proleukin.com. IL-2 is being studied in clinical development programs as a component of cell immunotherapies, including TIL therapy.

PharmaCyte Biotech Completes Medical Manual for IND Filing

On May 4, 2020 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that it has completed a medical manual that is pivotal to the completion of its Investigational New Drug application (IND) filing (Press release, PharmaCyte Biotech, MAY 4, 2020, View Source [SID1234556969]). The manual, "Angiography Manual – Transarterial Chemoinfusion of the Pancreas" (Angiography Procedure Manual), will be used to guide Interventional Radiologists on the placement of a catheter that begins at the femoral artery in the leg and ends as close to the pancreatic tumor as possible in patients participating in PharmaCyte’s planned Phase 2b clinical trial. By following the directions in this manual, Interventional Radiologists will be able to precisely place the Cell-in-a-Box capsules inside patients.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Angiography Manual was prepared by a team of medical professionals. The initial version was prepared by Dr. David H. O’Leary, an Interventional Radiologist and Senior Vice President of the Medical Department at Medpace (PharmaCyte’s Contract Research Organization (CRO)). Dr. O’Leary’s version was then reviewed by Dr. Manuel Hidalgo, the Principal Investigator (PI) for PharmaCyte’s planned Phase 2b clinical trial for locally advanced, inoperable pancreatic cancer (LAPC), and Dr. Matthias Löhr, who was the PI for the first two clinical trials using PharmaCyte’s treatment for LAPC.

Dr. Jens-Christian Kröeger, who was the Interventional Radiologist during the two earlier clinical trials provided valuable assistance in the preparation of the Angiography Manual, and Dr. Löhr was able to work side-by-side with Dr. Kröeger as the angiography procedure was performed during those trials. A final review of the Angiography Manual was performed by Dr. Bradley Pua, an Interventional Radiologist with Weill Cornell Medicine and a colleague of Dr. Hidalgo.

Kenneth L. Waggoner, the Chief Executive Officer of PharmaCyte Biotech, stated, "We are deeply indebted to all of the physicians who contributed to the preparation of the Angiography Procedure Manual. This very important medical document makes up a crucial component of our IND and gets us one step closer to submitting our IND to the U.S. FDA, as we’re diligently completing the last remaining items for that submission."

VBL Therapeutics to Report First Quarter 2020 Financial Results on May 14

On May 4, 2020 VBL Therapeutics (Nasdaq: VBLT), a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class treatments for cancer, reported that it will host a conference call and live audio webcast on Thursday, May 14, 2020 at 8:30am Eastern Time to report first quarter ended March 31, 2020 financial results and to provide a corporate update (Press release, VBL Therapeutics, MAY 4, 2020, View Source [SID1234556968]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Thursday May 14th @ 8:30amET
From the US: 877-407-9208
International: 201-493-6784
Israel: 1 809 406 247
Conference ID: 13703295
Webcast: View Source