Enlarged Drug Portfolio for Gastric Cancer and Breast Cancer, Strengthened Anti-tumor Competitiveness – Licensing Cooperation between Fosun Pharma’s Monoclonal Antibody Platform Henlius and Korea’s AbClon

On 29 October 2016, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. ("Fosun Pharma", stock code: 600196.SH, 02196.HK) reported in its A-share announcement that Shanghai Henlius Biotech Inc. ("Henlius"), a holding subsidiary under its control, and AbClon Inc. ("AbClon") from Korea entered into a license agreement for monoclonal antibody AC101 (Press release, Fosun Pharmaceutical, OCT 31, 2016, View Source [SID1234517344]).

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AC101, an innovative monoclonal antibody developed by AbClon targeting gastric cancer and breast cancer, is currently under pre-clinical trial studies. Under the agreement, Henlius is granted the exclusive rights to develop and commercialize AC101 across the Great China region. This cooperation will put into play techniques and advantages of Henlius as an existing monoclonal antibody development platform of Fosun Pharma in further diversifying its product lines to enhance its competitiveness in the anti-tumor therapeutic area.

AC101 is the first novel monoclonal antibody discovered using AbClon’s proprietary antibody development platform New Epitope Screening Technology (Nest). Currently there is no similar product in any market worldwide. According to statistics from Global Data, the gastric cancer treatment market is projected to reach US$4.4 billion globally by the year 2024, and the HER2-positive breast cancer treatment market to reach US$12.7 billion by the year 2023.

At present, AC101 is still under pre-clinical trial studies and it is uncertain that it will be able to start clinical trials. Any clinical trial, registration, manufacture and other matters in relation to it in the relevant region is subject to approval of relevant pharmaceutical authorities.

Dr. Scott Liu, President and CEO of Shanghai Henlius indicated that, "Shanghai Henlius’ mission is to provide high-quality, affordable and accessible healthcare products worldwide. We are very excited to add another promising antibody product to our expanding portfolio. We believe AC101 in combination with the proprietary recombinant humanized anti-HER2 monoclonal antibody injection (trastuzumab biosimilar) developed by Henlius will enhance the efficacy against gastric cancer and breast cancer." Phase I clinical study for the proprietary recombinant humanized anti-HER2 monoclonal antibody (trastuzumab biosimilar) developed by Henlius has been completed and the results show that the new drug is safe and has the same efficacy as the corresponding proprietary drug Herceptin. Phase III clinical trial for the new drug will commence within this year.

Dr. Jong-Seo Lee, CEO of AbClon, also expressed his delight in having a licensing deal with Henlius, one of the most prominent monoclonal antibody pharmaceutical companies in China, and he looked forward to more partnerships with premier biopharmaceutical companies such as Henlius.

TESARO Announces Presentation of Niraparib Data at the 2016 IGCS Biennial Meeting

On October 31, 2016 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, reported the presentation of data from the ENGOT-OV16/NOVA trial of niraparib at the 2016 International Gynecologic Cancer Society (IGCS) Biennial Meeting in Lisbon, Portugal (Press release, TESARO, OCT 31, 2016, View Source [SID1234516235]). These data were presented on Sunday, October 30 during the Best Oral session by Dr. Ursula Matulonis, M.D., Medical Director of the Gynecologic Oncology Program at Dana-Farber Cancer Institute and principal investigator on the ENGOT-OV16/NOVA trial, during the Best Oral session. The results were previously published in the New England Journal of Medicine on October 8, 2016 and presented at the ESMO (Free ESMO Whitepaper) 2016 Congress.

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"Many women with recurrent ovarian cancer experience a fear of recurrence in between regimens of platinum-based chemotherapy. The availability of an oral maintenance treatment that could lengthen the progression free survival interval between rounds of platinum-based chemotherapy with a tolerable side effect profile could be very empowering for patients," said Dr. Matulonis. "The data from ENGOT-OV16/NOVA are extremely encouraging and demonstrate the potential of niraparib to offer a meaningful benefit for our patients with ovarian cancer."

"We are grateful for the patients, their families, and the caregivers that participated in the ENGOT-OV16/NOVA study, and we would like to thank our partners at ENGOT for their diligence in executing this trial," said Mary Lynne Hedley, Ph.D., President and COO of TESARO. "We believe the results of this Phase 3 study demonstrated a meaningful benefit for women with platinum sensitive, recurrent ovarian cancer. We are pleased that the EMA recently accepted for review the MAA for niraparib, and we are on track to complete the rolling NDA submission imminently."

ENGOT-OV16/NOVA is a double-blind, placebo-controlled, international Phase 3 trial of niraparib that enrolled 553 patients with recurrent ovarian cancer who were in response to their most recent platinum-based chemotherapy. This trial was designed to assess progression free survival (PFS) in a broad population of patients who were assigned to one of two cohorts based upon germline BRCA mutation status. The ENGOT-OV16/NOVA trial successfully achieved its primary endpoint in both cohorts, demonstrating that niraparib treatment significantly prolonged PFS compared to control in patients who were germline BRCA mutation (gBRCAmut) carriers and in patients who were not germline BRCA mutation (non-gBRCAmut) carriers. A high proportion of patients in both treatment groups in both cohorts had received three or more prior lines of chemotherapy.

The most common (≥10%) treatment-emergent grade 3/4 adverse events in the niraparib arm were thrombocytopenia (33.8%), anemia (25.3%), and neutropenia (19.6%) with treatment discontinuation for these events of 3.3%, 1.4% and 1.9%, respectively. Thrombocytopenia was not associated with grade 3/4 bleeding events. The majority of these hematological laboratory abnormalities occurred within the first three cycles; following dose modifications the incidence of these lab abnormalities decreased and thrombocytopenia and neutropenia were infrequent beyond cycle 3. The rates of MDS/AML in the niraparib (1.4%) and control (1.1%) arms were similar. There were no deaths among patients during study treatment.

About the Phase 3 ENGOT-OV16/NOVA Clinical Trial of Niraparib
ENGOT-OV16/NOVA is a double-blind, placebo-controlled, international Phase 3 trial of niraparib that enrolled 553 patients with recurrent ovarian cancer who were in a response to their most recent platinum-based chemotherapy. Patients were enrolled into one of two independent cohorts based on germline BRCA mutation status. One cohort enrolled patients who were germline BRCA mutation carriers (gBRCAmut), and the second cohort enrolled patients who were not germline BRCA mutation carriers (non-gBRCAmut) and included patients with HRD-positive and HRD-negative tumors. Within each cohort, patients were randomized 2:1 to receive niraparib or placebo and were treated continuously with placebo or 300 milligrams of niraparib, dosed as three 100 milligram tablets once per day, until progression. The primary endpoint of this study was progression-free survival (PFS). Secondary endpoints include patient-reported outcomes, chemotherapy-free interval length, PFS 2, overall survival, and other measures of safety and tolerability. More information about this trial is available at View Source

About Niraparib
Niraparib is an oral, once-daily PARP inhibitor that is currently being evaluated in four ongoing pivotal trials. TESARO is building a robust niraparib franchise by assessing activity across multiple tumor types and by evaluating several potential combinations of niraparib with other therapeutics. The ongoing development program for niraparib includes a Phase 3 trial in patients with platinum-sensitive, recurrent ovarian cancer (the NOVA trial); a Phase 3 trial in patients with first-line ovarian cancer (the PRIMA trial); a registrational Phase 2 treatment trial in patients with ovarian cancer (the QUADRA trial); and a Phase 3 trial for the treatment of patients with BRCA-mutant breast cancer (the BRAVO trial). Several combination studies are also underway, including trials of niraparib plus pembrolizumab and niraparib plus bevacizumab. Janssen Biotech has licensed rights to develop and commercialize niraparib specifically for patients with prostate cancer worldwide, except in Japan.

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to niraparib for the treatment of patients with recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer. TESARO has initiated a rolling submission of a New Drug Application (NDA) for niraparib to the FDA, and intends to complete this submission during the fourth quarter. The Marketing Authorization Application (MAA) for niraparib has been submitted to and accepted for review by the European Medicines Agency (EMA) for the maintenance treatment of patients with platinum-sensitive, recurrent ovarian cancer who are in response to platinum-based chemotherapy.

Niraparib is an investigational agent and, as such, has not been approved by the U.S. FDA, the European Medicines Agency (EMA), or any other regulatory agencies.

About Ovarian Cancer
Approximately 22,000 women are diagnosed each year with ovarian cancer in the United States, and more than 65,000 women are diagnosed annually in Europe. Ovarian cancer is the fifth most frequent cause of cancer death among women. Despite high response rates to platinum-based chemotherapy in the second-line advanced treatment setting, approximately 85% of patients will experience recurrence within two years. If approved, niraparib may address the difficult "watchful waiting" periods experienced by patients with recurrent ovarian cancer in between cycles of platinum-based chemotherapy

Novartis Wins Two Prestigious Prix Galien Foundation Awards; Gleevec® recognized as "Discovery of the Decade" for Best Pharmaceutical Product, Cosentyx® as Best Biotechnology Product

On October 31, 2016 Novartis reported that it has been awarded the prestigious 2016 Prix Galien USA Award for Best Biotechnology Product for Cosentyx (secukinumab), as well as the Prix Galien Foundation "Discovery of the Decade" Award for Best Pharmaceutical Product for the drug Gleevec (imatinib mesylate) (Press release, Novartis, OCT 31, 2016, View Source [SID1234516146]). The awards were presented at a ceremony in New York City.

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"We are honored to receive these prestigious awards for Cosentyx and Gleevec, which not only have changed the practice of medicine for certain conditions, but also represent years of hard work by our scientists," said Joseph Jimenez, CEO of Novartis. "These wins underscore our commitment to addressing the unmet medical needs of patients through science-based innovation."

Cosentyx was the first fully human interleukin-17A (IL-17A) antagonist approved by the US Food and Drug Administration (FDA) in 2015 for the treatment of adults with moderate to severe plaque psoriasis[1]. Psoriasis affects an estimated 7.5 million people in the US[2]. It is a chronic immune-mediated disease characterized by thick and extensive skin lesions (plaques), which can cause itching, scaling, and pain[2]. Cosentyx was also approved for the treatment of active ankylosing spondylitis and psoriatic arthritis in 2016[1].

The discovery of Gleevec marked the first time in the history of cancer treatment that scientists were able to identify a chromosomal abnormality and then develop a drug that would target that specific protein. Gleevec, a molecularly targeted treatment, rapidly became a therapy of choice for Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) and KIT (CD117)-positive gastrointestinal stromal tumors (KIT+ GIST)[3]. By showing that certain diseases can share a drug-sensitive target with seemingly unrelated ailments, and that molecular targeting can be medically and commercially successful, Gleevec helped establish a new paradigm for drug development.

About the Prix Galien Awards
Considered "the pharmaceutical industry’s Nobel Prize," the Prix Galien rewards excellence in scientific innovation that improves the state of human health. The award was first established in 1970 by French pharmacist Roland Mehl and was inaugurated in the United States in 2007 to recognize the technical, scientific and clinical research skills necessary to develop innovative medicines. Since 1970, Novartis has received more than 40 national Prix Galien awards in fifteen countries for innovative therapies such as Gleevec (imatinib mesylate), Rimactane (rifampin), Parlodel (bromocriptine mesylate), Sandimmune (cyclosporine), Sandostatin (octreotide acetate), Simulect (basiliximab) and Visudyne (verteporfin)[4].

The "Discovery of the Decade" is a special once-in-10-years recognition for distinguished industry achievement in medical innovation. The awards honor extraordinary human health impact in three categories – Best Pharmaceutical Product, Best Biotechnology Product, and Best Medical Technology. In addition to Gleevec (imatinib mesylate), two other Novartis products were nominated for "Discovery of the Decade," including Coartem (artemether/ lumefantrine) for Best Pharmaceutical Product and Promacta (eltrombopag olamine) for Best Biotechnology Product. Gleevec won the Prix Galien International Prize in 2002, and was recognized again in 2009 by the Prix Galien USA committee for "Best Pharmaceutical Product"[5].

About Cosentyx and interleukin-17A (IL-17A)
Cosentyx is a fully human monoclonal antibody (mAB) that selectively binds to the interleukin-17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor[1].

Cosentyx is approved in more than 65 countries for the treatment of moderate to severe plaque psoriasis which includes the European Union countries, Japan, Switzerland, Australia, the U.S. and Canada[6]. In the U.S., Cosentyx is approved for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy (light therapy). Cosentyx is also approved in the US for adult patients with active ankylosing spondylitis and active psoriatic arthritis[1].

More than 10,000 patients have been treated with Cosentyx in clinical trial settings across multiple indications, and over 50,000 patients have been treated in the post-marketing setting worldwide[7].

About Gleevec (imatinib mesylate)
Gleevec (imatinib mesylate) tablets are indicated for newly diagnosed adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in the chronic phase (CP). Gleevec is also indicated for the treatment of patients with Ph+ CML in blast crisis (BC), accelerated phase (AP), or in CP after failure of interferon-alpha therapy.

Additionally, Gleevec is indicated for Patients with KIT(CD117)-positive gastrointestinal stromal tumors (GIST) that cannot be surgically removed and/or have spread to other parts of the body and for adult patients after surgery who have had their KIT (CD117)-positive GIST completely removed.

INDICATIONS
COSENTYX (secukinumab) is a prescription medicine used to treat adults:

with moderate to severe plaque psoriasis that involves large areas or many areas of the body, and who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light, alone or with systemic therapy)
with active psoriatic arthritis
with active ankylosing spondylitis
IMPORTANT SAFETY INFORMATION
Do not use COSENTYX if you have had a severe allergic reaction to secukinumab or any of the other ingredients in COSENTYX. See the Medication Guide for a complete list of ingredients.

COSENTYX is a medicine that affects your immune system. COSENTYX may increase your risk of having serious side effects such as:

Infections
COSENTYX may lower the ability of your immune system to fight infections and may increase your risk of infections.

Your doctor should check you for tuberculosis (TB) before starting treatment with COSENTYX.
If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with COSENTYX and during treatment with COSENTYX.
Your doctor should watch you closely for signs and symptoms of TB during treatment with COSENTYX. Do not take COSENTYX if you have an active TB infection.
Before starting COSENTYX, tell your doctor if you:

are being treated for an infection
have an infection that does not go away or that keeps coming back
have TB or have been in close contact with someone with TB
think you have an infection or have symptoms of an infection such as:
fevers, sweats, or chills
warm, red, or painful skin or sores on your body
muscle aches
diarrhea or stomach pain
cough
burning when you urinate or urinate more often than normal
shortness of breath

blood in your phlegm

weight loss

After starting COSENTYX, call your doctor right away if you have any signs of infection listed above. Do not use COSENTYX if you have any signs of infection unless you are instructed to by your doctor.

Inflammatory Bowel Disease
New cases of inflammatory bowel disease or "flare-ups" can happen with COSENTYX, and can sometimes be serious. If you have inflammatory bowel disease (ulcerative colitis or Crohn’s disease), tell your doctor if you have worsening disease symptoms during treatment with COSENTYX or develop new symptoms of stomach pain or diarrhea.

Serious Allergic Reactions
Serious allergic reactions can occur. Get emergency medical help right away if you get any of the following symptoms: feeling faint; swelling of your face, eyelids, lips, mouth, tongue, or throat; trouble breathing or throat tightness; chest tightness; or skin rash. If you have a severe allergic reaction, do not give another injection of COSENTYX.

Before starting COSENTYX, tell your doctor if you:

have any of the conditions or symptoms listed above for infections
have inflammatory bowel disease (Crohn’s disease or ulcerative colitis)
are allergic to latex. The needle caps contain latex.
have recently received or are scheduled to receive an immunization (vaccine). People who take COSENTYX should not receive live vaccines.
have any other medical conditions
are pregnant or plan to become pregnant. It is not known if COSENTYX can harm your unborn baby. You and your doctor should decide if you will use COSENTYX.
are breastfeeding or plan to breastfeed. It is not known if COSENTYX passes into your breast milk.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of your medicines to show your doctor and pharmacist when you get a new medicine.

How should I use COSENTYX?
See the detailed Instructions for Use that comes with your COSENTYX for information on how to prepare and inject a dose of COSENTYX, and how to properly throw away (dispose of) used COSENTYX Sensoready pens and prefilled syringes.

Use COSENTYX exactly as prescribed by your doctor.
If your doctor decides that you or a caregiver may give your injections of COSENTYX at home, you should receive training on the right way to prepare and inject COSENTYX. Do not try to inject COSENTYX yourself, until you or your caregiver has been shown how to inject COSENTYX by your doctor or nurse.
The most common side effects of COSENTYX include: cold symptoms, diarrhea, and upper respiratory infections. These are not all of the possible side effects of COSENTYX. Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch (link is external), or call 1-800-FDA-1088.

Please see accompanying full Prescribing Information (link is external), including Medication Guide (link is external).

Gleevec Important Safety Information
Gleevec can cause fetal harm when administered to a pregnant woman. Women should not become pregnant, and should be advised of the potential risk to the unborn child.

Gleevec is often associated with edema (swelling) and serious fluid retention. Studies have shown that edema (swelling) tended to occur more often among patients who are 65 and older or those taking higher doses of Gleevec.

Cytopenias (reduction or lack of certain cell elements in blood circulation), such as anemia, have occurred. If the cytopenia is severe, your doctor may reduce your dose or temporarily stop your treatment with Gleevec.

Severe congestive heart failure and left ventricle dysfunction have been reported, particularly in patients with other health issues and risk factors. Patients with heart disease or risk factors or history of renal failure will be monitored and treated for the condition.

Severe liver problems (hepatotoxicity) may occur. Cases of fatal liver failure and severe liver injury requiring liver transplants have been reported with both short-term and long-term use of Gleevec.

Reactivation of hepatitis B can occur in patients who are chronic carriers of this virus after receiving TKI treatment.

Bleeding may occur. Severe gastrointestinal (GI) bleeding has been reported in patients with KIT+ GIST. GI tumor sites may be the cause of this bleeding; therefore, GI symptoms should be monitored at the start of treatment.

In patients with hypereosinophilic syndrome (a condition with increased eosinophils, which are a type of white blood cell) and heart involvement, cases of heart disease (cardiogenic shock/left ventricular dysfunction) have been associated with the initiation of Gleevec therapy.

Skin reactions, such as fluid-filled blisters, have been reported with the use of Gleevec.

Clinical cases of hypothyroidism (reduction in thyroid hormones) have been reported in patients taking levothyroxine replacement with Gleevec.

Long-term use may result in potential liver, kidney, and/or heart toxicities; immune system suppression may also result from long-term use.

GI perforation (small holes or tears in the walls of the stomach or intestine), in some cases fatal, has been reported.

Growth retardation has been reported in children taking Gleevec. The long-term effects of extended treatment with Gleevec on growth in children are unknown.

Cases of tumor lysis syndrome (TLS), which refers to a metabolic and electrolyte disturbance caused by the breakdown of tumor cells, have been reported and can be life-threatening in some cases. Correction of clinically significant dehydration and treatment of high uric acid levels are recommended prior to initiation of Gleevec.

Reports of motor vehicle accidents have been received in patients receiving Gleevec. Caution patients about driving a car or operating machinery.

Almost all patients treated with Gleevec experience side effects at some time. Some common side effects you may experience are fluid retention, muscle cramps or pain and bone pain, abdominal pain, loss of appetite, vomiting, diarrhea, decreased hemoglobin, abnormal bleeding, nausea, fatigue and rash.

Gleevec is sometimes associated with stomach or intestinal irritation. Gleevec should be taken with food and a large glass of water to minimize this problem. There have been rare reports, including deaths, of stomach or intestinal perforation (a small hole or tear).

If you are experiencing any of the mentioned side effects, please be sure to speak with your doctor immediately.

Do not take any other medications without talking to your doctor or pharmacist first, including Tylenol (acetaminophen); herbal products (St. John’s wort, Hypericum perforatum); Coumadin (warfarin sodium); rifampin; erythromycin; metoprolol; ketoconazole; and Dilantin (phenytoin). Taking these with Gleevec may affect how they work, or affect how Gleevec works.

You should also tell your doctor if you are taking or plan to take iron supplements. Patients should also avoid grapefruit juice and other foods that may affect how Gleevec works.

Please see full Prescribing Information.

Foundation Medicine and Sarah Cannon Collaborate to Advance Personalized Medicine for Patients with Cancer

On October 31, 2016 Foundation Medicine, Inc. (NASDAQ:FMI) and Sarah Cannon Research Institute (Sarah Cannon) reported a collaboration focused on advancing personalized medicine utilizing molecular information for patients across Sarah Cannon’s cancer programs in the United States (Press release, Foundation Medicine, OCT 31, 2016, View Source [SID1234516142]). The organizations will gather results from Foundation Medicine’s full suite of comprehensive genomic profiling (CGP) assays to personalize treatment options for patients and to ultimately support improved outcomes.

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Sarah Cannon is one of the world’s leading clinical research organizations conducting community-based clinical trials across a global network. Researchers can use Foundation Medicine’s CGP assays, FoundationOne for use with solid tumors, FoundationOne Heme for use with hematologic malignancies and FoundationACT for use as a liquid biopsy, to identify eligible patients for participation in Sarah Cannon’s clinical studies. Foundation Medicine’s CGP assays aid treating physicians and researchers to more effectively screen and match patients to early and late-phase clinical trials based on their genomic information. Sarah Cannon will also integrate Interactive Cancer Explorer, Foundation Medicine’s physician facing decision support portal, across its network to facilitate clinico-genomic knowledge among researchers and to enhance patient access to precision therapeutics.

Additionally, Sarah Cannon and Foundation Medicine have entered into a master research program agreement to collaborate on the development of research studies, as well as clinical programs designed to evaluate and establish the most appropriate use of Foundation Medicine’s assays into clinical care pathways.

"Our physicians are at the forefront of clinical research through our work with novel investigative therapies," said Howard A. "Skip" Burris, M.D., president, clinical operations and chief medical officer, Sarah Cannon. "Clinical trials, particularly those where patients can be molecularly matched to a study, are an integral part of effectively treating many types of cancers and accelerating patient access to novel therapies. We’re excited to collaborate with Foundation Medicine as we continue to enhance access to molecular information, which helps improve clinical care and inform research across our network."

Sarah Cannon and Foundation Medicine will also work together to develop training and educational programs that support the advancement of personalized medicine, including work with Sarah Cannon’s Nurse Navigator Program, a high-touch, personalized support program that enables nurses to comprehensively manage a patient’s experience with cancer.

"Precision medicine in cancer can be achieved by innovating new ideas that accelerate patient access to novel compounds in development," said Steven Kafka, president and chief operating officer for Foundation Medicine. "Together with Sarah Cannon, we believe we are in a unique position to eliminate roadblocks to patient access, to integrate genomics knowledge into clinical pathways and to extend that knowledge across the cancer care continuum to accelerate research and drive better outcomes for all patients."

Mateon Announces Presentation of CA4P Posters at Meeting of the International Gynecologic Cancer Society

On October 31, 2016 Mateon Therapeutics, Inc. (Nasdaq:MATN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of orphan oncology indications, reported two poster presentations at the 16th Biennial Meeting of the International Gynecologic Cancer Society, held October 29-31 in Lisbon, Portugal (Press release, Mateon Therapeutics, OCT 31, 2016, View Source [SID1234516126]). The poster presentations highlighted previously presented data demonstrating results from the treatment of recurrent ovarian cancer with CA4P, and also provided an overview of Mateon’s Phase 2/3 FOCUS Study evaluating the addition of CA4P to current standard of care in patients with platinum-resistant ovarian cancer.

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Poster Presentations

Improved Progression-Free Survival among Women with Measurable Recurrent Ovarian Carcinoma Treated with CA4P Plus Bevacizumab: A Post-Hoc Analysis of GOG-0186I
FOCUS Study: Physician’s Choice Chemotherapy (PCC) Plus Bevacizumab and CA4P Versus PCC Plus Bevacizumab and Placebo in Platinum-Resistant Ovarian Cancer (prOC)
The first poster presentation highlighted data from post-hoc analyses from the GOG-0186I Study in patients with measurable disease. Study GOG-0186I evaluated the addition of CA4P to treatment with bevacizumab in patients with recurrent ovarian cancer. In the intent-to-treat population, as well as in a subgroup of patients with measurable disease, the addition of CA4P improved progression-free survival (PFS), including improvements in PFS of 6.2 months for patients with larger tumors. The second poster described the design of the company’s on-going FOCUS Study.

"We believe these highly positive data generated for CA4P in combination with anti-angiogenic agents demonstrate the potential for CA4P to alter the treatment landscape for ovarian cancer, and they provide us with confidence as we move our program forward," stated William D. Schwieterman, M.D., President and Chief Executive Officer of Mateon. "Our clinical investigators are excited to participate in the FOCUS Study, a phase 2/3 trial we initiated in June 2016, and we share their excitement as we look forward to the availability of key data from this study in the second half of 2017."