Mateon Therapeutics to Present New Improved Survival Outcomes for CA4P in Recurrent Ovarian Cancer at June 27 Investor Event

On June 20, 2016 Mateon Therapeutics, Inc. (Nasdaq:MATN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of orphan oncology indications, reported that it plans to hold an event for investors on Monday, June 27, 2016 at 12:00 pm at the Lotte New York Palace Hotel with Bradley J. Monk, M.D., a recognized leader in ovarian cancer and Director of the Division of Gynecologic Oncology at St. Joseph’s Hospital and Medical Center (Press release, Mateon Therapeutics, JUN 20, 2016, View Source [SID:1234513464]). To listen to a live version of the audio webcast, with presentations expected to begin at approximately 12:15 pm, please visit the company’s website, www.mateon.com. Under the "Investors & News" tab, select the link to "Events & Presentations." A replay of the webcast will be available at this same location after the conclusion of the live event.

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New Analyses of Data Received from Study GOG-0186I

At the investor event on June 27, new analyses will be presented from a more recent (November 2015) and more mature dataset from the GOG-0186I Study in patients with recurrent ovarian cancer, including analyses to further define the patient population most likely to benefit from treatment with CA4P. Given the preclinical data and the mechanism of action of CA4P, Mateon believes that CA4P is likely to have the greatest effect in larger tumors, and therefore performed additional analyses on data from patients with "measurable disease" and on those with larger tumor volumes.

Results of these analyses are listed below.

Intent-to-Treat Population
The GOG-0186I Study compared the combination of CA4P and bevacizumab (CA4P-treated) to bevacizumab alone (control) in women with recurrent ovarian cancer, enrolling a total of 107 patients. The median overall survival (OS) in the intent-to-treat (ITT) group was 3.2 months longer for the CA4P-treated patients compared to the control patients (25.2 vs. 22.0 months, respectively; HR=0.83, not statistically significant). Data published in the Journal of Clinical Oncology (dataset as of April 2015) showed an improvement in median OS of 2.6 months for CA4P-treated patients.

Patients with Measurable Disease
The GOG-0186I Study included 81 patients (75.7% of study patients) with recurrent ovarian cancer that was deemed "measurable", a pre-specified covariate defined by RECIST criteria, and 26 patients (24.3%) deemed "non-measurable." Measurable disease is generally defined as primary tumor sizes greater than 1 cm in diameter, while non-measurable tumors are generally identified and monitored by increased serum CA-125 antigen levels, ascites, or other clinical signs of disease.

Patients with measurable disease treated with CA4P had a 5.6 month improvement in median OS (26.8 vs. 21.2 months; 22% reduction in the risk of death; HR=0.78, not statistically significant), and a 3.7 month improvement in progression free survival (PFS) (9.8 vs. 6.1 months; HR=0.60, p=0.027) compared to control patients with measurable disease.

Additional analyses were conducted on patients with measurable disease whose tumors were larger than the median baseline tumor size (tumor size ≥5.7 cm; n=41). CA4P-treated patients with these tumor sizes experienced a 48% reduction in the risk of death (HR=0.52; p=0.095) and a 6.2 month improvement in median PFS (10.5 vs. 4.3 months; HR=0.55, p=0.071) compared to control patients.

"Overall survival is the gold standard for determining clinical benefit in oncology indications. The most recent analyses from this more mature dataset show an improvement in overall survival for all patients treated with CA4P, greater overall survival for patients whose tumors can be measured, and initial evidence of an even greater survival for patients with tumors which are large and the most difficult to treat," said William D. Schwieterman, M.D., President and Chief Executive Officer of Mateon. "These remarkable outcomes align entirely with our preclinical data and the mechanism-of-action of CA4P, provide us with a deep understanding of where and how best to use CA4P as we move forward, and strongly support the efficacy of combination vascular targeted therapy for the treatment of ovarian and other cancers."

Mateon is planning to study CA4P for the treatment of patients with platinum-resistant ovarian cancer in a double-blind randomized placebo controlled study of CA4P in combination with bevacizumab and physician’s choice chemotherapy (PCC) compared to bevacizumab and PCC (the "FOCUS" study). FOCUS will only enroll patients with measurable disease, and includes pre-specified analyses in its first phase that are designed to confirm the outcomes reported today. If these are confirmed, Mateon will consider expansion of its development program for CA4P from platinum-resistant ovarian cancer to the much larger group of patients with recurrent ovarian cancer.

PharmaCyte Biotech CEO Interviewed Live During Marcum MicroCap Conference

On June 20, 2016 PharmaCyte Biotech, Inc. (OTCQB:PMCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that Kenneth L. Waggoner, the Chief Executive Officer of PharmaCyte, was interviewed by Stock News Now (SNN) at the 5th Annual Marcum MicroCap Conference in New York City (Press release, PharmaCyte Biotech, JUN 20, 2016, View Source [SID:1234513462]). The SNNLive video interview can be viewed by clicking on the following link: www.PharmaCyte.com/Media.

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During his interview, Mr. Waggoner describes how PharmaCyte plans to use its live cell encapsulation technology, known as Cell-in-a-Box, for the development of treatments for locally advanced, inoperable pancreatic cancer and for Type 1 and insulin-dependent Type 2 diabetes. Mr. Waggoner also discusses the mechanism of action PharmaCyte uses to treat cancerous tumors and talks about PharmaCyte’s plans to begin a Phase 2b clinical trial in patients with locally advanced, inoperable pancreatic cancer. That trial is planned to start in Q4 2016.

In discussing PharmaCyte’s efforts to develop a treatment for diabetes, Mr. Waggoner talks about the preclinical studies that are being conducted concurrently by several renowned experts in the field of diabetes in various countries around the globe. All of these experts are members of PharmaCyte’s International Diabetes Consortium. Mr. Waggoner also explains that by conducting their studies as part of a consortium, rather than sequentially, the overall treatment development timeline has been shortened considerably. This will allow PharmaCyte to potentially begin a clinical trial in diabetes as early as late 2017.

Varian Medical Systems Launches Proton Therapy Blog

On June 20, 2016 Varian Medical Systems (NYSE: VAR), reported the launch of Spot ON, a company blog about proton therapy for the treatment of cancer (Press release, Varian Medical Systems, JUN 20, 2016, View Source [SID:1234513459]). Targeted at clinicians, physicists and administrators of radiotherapy centers around the world, Spot ON will deliver information about new technology developments, system deployments, research and insights from clinicians.

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The first Spot ON blog entry is from Dr. Carl Rossi, medical director of the Scripps Proton Therapy Center in San Diego, California. Dr. Rossi’s blog is an introduction to adaptive radiotherapy using intensity-modulated proton therapy.

Read the first blog entry here: www.varian.com/proton-therapy/spot-news/introduction-adaptive-radiotherapy-using-impt

"Varian is creating the Spot ON blog to increase the awareness and understanding of proton therapy and the important role it plays in cancer treatment," said Bill Hansen, director of marketing, Particle Therapy Division at Varian.

8-K – Current report

On June 20, 2016 Mateon Therapeutics, Inc. (Nasdaq:MATN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of orphan oncology indications, reported that it plans to hold an event for investors on Monday, June 27, 2016 at 12:00 pm at the Lotte New York Palace Hotel with Bradley J. Monk, M.D., a recognized leader in ovarian cancer and Director of the Division of Gynecologic Oncology at St. Joseph’s Hospital and Medical Center (Filing, 8-K, OXiGENE, JUN 20, 2016, View Source [SID:1234513458]). To listen to a live version of the audio webcast, with presentations expected to begin at approximately 12:15 pm, please visit the company’s website, www.mateon.com. Under the "Investors & News" tab, select the link to "Events & Presentations." A replay of the webcast will be available at this same location after the conclusion of the live event.

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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!

New Analyses of Data Received from Study GOG-0186I
At the investor event on June 27, new analyses will be presented from a more recent (November 2015) and more mature dataset from the GOG-0186I Study in patients with recurrent ovarian cancer, including analyses to further define the patient population most likely to benefit from treatment with CA4P. Given the preclinical data and the mechanism of action of CA4P, Mateon believes that CA4P is likely to have the greatest effect in larger tumors, and therefore performed additional analyses on data from patients with "measurable disease" and on those with larger tumor volumes.
Results of these analyses are listed below.

Intent-to-Treat Population
The GOG-0186I Study compared the combination of CA4P and bevacizumab (CA4P-treated) to bevacizumab alone (control) in women with recurrent ovarian cancer, enrolling a total of 107 patients. The median overall survival (OS) in the intent-to-treat (ITT) group was 3.2 months longer for the CA4P-treated patients compared to the control patients (25.2 vs. 22.0 months, respectively; HR=0.83, not statistically significant). Data published in the Journal of Clinical Oncology (dataset as of April 2015) showed an improvement in median OS of 2.6 months for CA4P-treated patients.

Patients with Measurable Disease
The GOG-0186I Study included 81 patients (75.7% of study patients) with recurrent ovarian cancer that was deemed "measurable", a pre-specified covariate defined by RECIST criteria, and 26 patients (24.3%) deemed "non-measurable." Measurable disease is generally defined as primary tumor sizes greater than 1 cm in diameter, while non-measurable tumors are generally identified and monitored by increased serum CA-125 antigen levels, ascites, or other clinical signs of disease.

Patients with measurable disease treated with CA4P had a 5.6 month improvement in median OS (26.8 vs. 21.2 months; 22% reduction in the risk of death; HR=0.78, not statistically significant), and a 3.7 month improvement in progression free survival (PFS) (9.8 vs. 6.1 months; HR=0.60, p=0.027) compared to control patients with measurable disease.

Additional analyses were conducted on patients with measurable disease whose tumors were larger than the median baseline tumor size (tumor size ³5.7 cm; n=41). CA4P-treated patients with these tumor sizes experienced a 48% reduction in the risk of death (HR=0.52; p=0.095) and a 6.2 month improvement in median PFS (10.5 vs. 4.3 months; HR=0.55, p=0.071) compared to control patients.

"Overall survival is the gold standard for determining clinical benefit in oncology indications. The most recent analyses from this more mature dataset show an improvement in overall survival for all patients treated with CA4P, greater overall survival for patients whose tumors can be measured, and initial evidence of an even greater survival for patients with tumors which are large and the most difficult to treat," said William D. Schwieterman, M.D., President and Chief Executive Officer of Mateon. "These remarkable outcomes align entirely with our preclinical data and the mechanism-of-action of CA4P, provide us with a deep understanding of where and how best to use CA4P as we move forward, and strongly support the efficacy of combination vascular targeted therapy for the treatment of ovarian and other cancers."

Mateon is planning to study CA4P for the treatment of patients with platinum-resistant ovarian cancer in a double-blind randomized placebo controlled study of CA4P in combination with bevacizumab and physician’s choice chemotherapy (PCC) compared to bevacizumab and PCC (the "FOCUS" study). FOCUS will only enroll patients with measurable disease, and includes pre-specified analyses in its first phase that are designed to confirm the outcomes reported today. If these are confirmed, Mateon will consider expansion of its development program for CA4P from platinum-resistant ovarian cancer to the much larger group of patients with recurrent ovarian cancer.

Cellectis Announces First Patient Treated in Phase 1 Trial of UCART19 in Pediatric Acute B Lymphoblastic Leukemia (B-ALL)

On June 20, 2016 Cellectis (Alternext: ALCLS – Nasdaq: CLLS), a biopharmaceutical company focused on developing immunotherapies based on gene edited CAR T-cells (UCART), reported that the first patient has been treated in the Phase I study of UCART19 in pediatric acute B lymphoblastic leukemia (B-ALL) at the University College of London (UCL) (Press release, Cellectis, JUN 20, 2016, View Source [SID:1234513467]). This UCART19 clinical trial is sponsored by Servier in close collaboration with Pfizer.

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The pediatric Phase I is an open label, non-comparative, monocenter study to evaluate the safety and ability of UCART19 to induce molecular remission in pediatric patients with relapsed or refractory CD19 positive B-cell acute lymphoblastic leukemia ahead of planned allogeneic haematopoeitic stem cell transplantation (allo-HSCT).

Cellectis will receive a milestone payment from Servier of an undisclosed amount.

About UCART19

UCART19 is an allogeneic CAR T-cell product candidate developed for treatment of CD19-expressing hematological malignancies, gene edited with TALEN. UCART19 is initially being developed in chronic lymphocytic leukemia (CLL) and acute lymphoblastic leukemia (ALL). Cellectis’ approach with UCART19 is based on the preliminary positive results from clinical trials using autologous products based on the CAR technology, and has the potential to overcome the limitation of the current autologous approach by providing an allogeneic, frozen, "off-the-shelf" T cell based medicinal product.

In November 2015, Servier acquired the exclusive rights to UCART19 from Cellectis. Following further agreements, Servier and Pfizer began collaborating on a joint clinical development program for this cancer immunotherapy. Pfizer has exclusive rights from Servier to develop and commercialize UCART19 in the United States, while Servier retains exclusive rights for all other countries.