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Alligator Bioscience Starts a Clinical Phase 1 Multicenter Trial

On April 7, 2015 Alligator Bioscience AB, a privately held Swedish biotech company developing immuno-oncology antibodies for directed immunotherapy of cancer, reported initiation of a phase 1 clinical trial of ADC-1013 for patients with advanced solid tumor disease (Press release, Alligator Bioscience, APR 7, 2015, View Source [SID1234538695]). ADC-1013 is an agonistic fully human monoclonal antibody targeting CD40, an immunostimulatory receptor found on antigen-presenting cells such as dendritic cells. Stimulation of CD40 on dendritic cells initiates a process leading to a dramatic increase in T effector cells attacking the tumor. In addition, a tumor-specific memory is established leading to long term immunity to the cancer.

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"This is a very important milestone for Alligator Bioscience" said Peter Benson, Chairman of the Board of Directors. "ADC-1013 has a very strong pre-clinical data package that gives high hopes for impressive clinical efficacy as well as an excellent safety profile that would allow combinations with other immune-oncology antibodies".

The phase 1 trial is a first-in-human, multicenter, open-label, multiple ascending dose study in patients with advanced solid tumors to determine the safety, pharmacokinetics and pharmacodynamics of intratumorally administered ADC-1013. The study includes a dose escalation part followed by an expansion at the optimal biological dose level. The primary endpoints are to identify the maximum tolerated dose and to study the safety and tolerability of ADC-1013. In addition, the trial will evaluate pharmacokinetics, immunogenicity, pharmacodynamics, antitumor activity, as well as mechanism of action of ADC-1013. The study will enroll up to 40 patients during the dose escalation and expansion phases at five centers in the United Kingdom, Denmark and Sweden. The study is managed by the international oncology contract research organization Theradex.

ADC-1013 has been developed in close collaboration with Professor Thomas Tötterman, Uppsala University, Sweden. Professor Tötterman is a pioneer in directed immunotherapy of cancer, a concept where the immune system is selectively activated locally in the tumor microenvironment in order to reduce systemic side effects while optimizing systemic anti-tumor effects. Professor Tötterman´s group has performed a number of successful in-vivo experiments demonstrating the powerful immune mediated anti-tumor effects of ADC-1013. The pre-clinical assessment of ADC-1013 indicates a favorable tolerability profile, which is likely to be further improved by the intratumoral route of administration in the first clinical trial. Manufacturing of ADC-1013 was performed by Cobra Biologics, using the maxXpress platform and the Ubiquitous Chromatin Opening Element (UCOE) technology, and by BioInvent International, who performed process development and manufacturing of the non-GMP and GMP batches.

http://finance.yahoo.com/news/panther-biotechnology-announces-agreement-acquire-110000889.html

On Apr 7, 2015 Panther Biotechnology, Inc. ( OTC PINK : PBYA ), a biotechnology company specializing in the development of enhanced therapeutics for the treatment of neoplastic and autoimmune disorders reported that it has entered into a definitive agreement with privately held Faulk Pharmaceuticals, Inc. to acquire Faulk’s pharmaceutical technology assets (Press release, Panther Biotechnology, APR 7, 2015, View Source [SID1234517414]). The transaction will provide Panther Biotechnology with a proprietary, multinationally patent protected, ligand-drug conjugate technology platform as well as a pipeline of drug product candidates that address unmet medical needs in oncology, autoimmune, antiviral and other disease indications.

The lead development program is a ligand-drug conjugate, TRF-DOX, a combination of transferrin glycoproteins with Doxorubicin for targeted delivery to tumors with the reduction of serious side effects. Clinical results demonstrate significant improvement over Doxorubicin. In a randomized, double blind, controlled study of patients with advanced FIGO stage IV ovarian cancer, the addition of either TRF-DOX or Doxorubicin to conventional chemotherapy was compared. Treatment with TRF-DOX resulted in a statistically significant increase in survival over Doxorubicin in patients with drug resistant ovarian cancer. In a non-blinded study in patients with acute leukemia, TRF-DOX was dosed at 10% of the usual dose and demonstrated an 87% decline in cancer cells circulating in the blood and no extension of the disease to bone marrow in 100% of the patients. TRF-DOX also exhibited a complete response of both the primary tumor and metastatic lesions in a patient with angiosarcoma after having failed three months of standard chemotherapy. Panther plans to submit applications for a phase 2 study in ovarian cancer and a phase 1a / 1b study in lung cancer.

TRF-DOX leverages the targeting ability of the plasma protein transferrin to deliver a powerful chemotherapeutic payload to cancerous cells. In vitro assays demonstrate growth inhibition of cancer cells that are resistant to other chemotherapies including Doxorubicin itself. Cytotoxicity studies demonstrate that a dose reduction of ten to one hundred-fold kills all cancer cells in multiple indications. In vivo studies demonstrate that TRF-DOX selectively binds tumors, inhibits tumor growth better than unmodified Doxorubicin, and increases survival. This improved therapeutic index suggests that further improvements in efficacy without added toxicity can be achieved.

Under the terms of the agreement, in exchange for substantially all the assets of Faulk Pharmaceuticals, Panther will issue shares of the common stock of Panther Biotechnology, Inc. in addition to a tiered royalty payment agreement based on the achievement of specified revenue milestones for any commercialized products based on the acquired technology. As part of the agreement, Panther will also gain access to a strong research and development network and a portfolio of domestic and international patents. The transaction is expected to close by the end of May.
"We are very excited to be acquiring Faulk Pharmaceutical’s technology, which we see as complementary to our efforts to develop and commercialize innovative pharmaceutical approaches for the treatment of cancer," stated Evan Levine, Chief Executive Officer of Panther Biotechnology. "This acquisition is a continuation of our strategy to build out a robust pipeline with novel pharmaceutical technologies that improve the efficacy and tolerability of validated therapies."

"Panther’s expanded pipeline now includes both early and later stage drugs that address multi-billion dollar market opportunities for cancer and autoimmune diseases. The oncology assets under exploration include molecules targeting certain cancer stem cells," said Dr. Jayesh Mehta who is a Director of Panther and Professor of Medicine at the Northwestern University Feinberg School of Medicine, and heads the Hematopoietic Stem Cell Transplant Program of Northwestern Memorial Hospital.

"Our decision to join Panther has been driven both by our conviction in their ability to leverage our technology platform and also by the high value we see in the TRF-DOX program," stated Dr. W. Page Faulk, founder of Faulk Pharmaceuticals. "We look forward to taking an active role in advancing TRF-DOX into new clinical trials, in addition to furthering the development of the pipeline of drug candidates we created. We are very pleased to become part of a company that shares our commitment to improving the lives of patients suffering from cancer and other diseases with high unmet medical needs."

AMPHIVENA THERAPEUTICS ACHIEVES DEVELOPMENT MILESTONES UNDER AGREEMENT WITH JANSSEN

On April 7, 2015 Amphivena Therapeutics, Inc., a developer of cancer immunotherapeutics reported the achievement of the first and second milestones under the terms of its agreement with Janssen Biotech, Inc. Amphivena and Janssen have selected a clinical candidate against an undisclosed tumor antigen for further development in hematologic malignancies (Press release, Amphivena Therapeutics, APR 7/, 2015, View Source [SID:SID1234515577]). The milestones triggered the release of payments to Amphivena. The financial details were not disclosed.
The agreement was facilitated by Johnson & Johnson Innovation.

Amphivena’s clinical candidate is based on the RECRUIT-TandAb platform, licensed from Affimed GmbH. RECRUIT TandAbs are bispecific molecules, with two binding sites for each specificity, that mediate potent and efficient tumor cell lysis by selectively binding to a tumor antigen on a cancer cell and the CD3 receptor complex on a T cell. They offer pharmacokinetic advantages over smaller, monovalent bispecific constructs.

"We are delighted to have achieved our milestones earlier than anticipated and look forward to advancing our therapeutic candidate rapidly to the clinic to address the unmet needs of patients suffering from life-threatening cancers," said Jeanmarie Guenot, Ph.D., president and chief executive officer of Amphivena Therapeutics.

"We believe Amphivena’s clinical candidate holds significant promise as a new, potent anti-cancer therapy," stated Luke Evnin, Managing Director of MPM Capital, and Amphivena’s lead investor. "We also appreciate Janssen’s ongoing support of, and participation in this important program, which we believe offers further validation of this novel approach to cancer treatment."

Global Strategic Partners Merck KGaA, Darmstadt, Germany, and Pfizer Finalize Agreement to Co-Promote XALKORI® (crizotinib)

On April 7, 2015 Merck KGaA and Pfizer reported the finalization of the co-promotion agreement allowing the companies to co-promote Pfizer’s anaplastic lymphoma kinase (ALK) inhibitor XALKORI (crizotinib) (Press release, Pfizer, APR 7, 2015, View Source [SID:1234502955]). This agreement showcases the alliance’s commitment to establishing a combined oncology sales organization in key markets in advance of the potential launch of avelumab*-based treatment regimens in the future.

XALKORI is the first ALK inhibitor approved in the United States, Japan and the European Union (EU) and is supported by two positive global randomized trials in the first- and second-line ALK-positive advanced non-small cell lung cancer (NSCLC) treatment settings. To date, globally more than 8,000 patients have been treated with XALKORI, including those who received XALKORI in clinical trials.

Under the agreement, XALKORI will be co-promoted in two waves, the first of which will begin in the second and third quarters of 2015 in the United States, Canada, Japan and five European Union countries (France, Germany, Italy, Spain and the United Kingdom). In the United States and Canada, XALKORI will be co-promoted by EMD Serono, the US and Canadian biopharmaceutical businesses of Merck KGaA, Darmstadt, Germany. The second wave will begin in 2016 and includes China and Turkey.

In 2015, Merck KGaA, Darmstadt, Germany, will receive a reimbursement associated with its promotion of XALKORI, followed by an 80 percent (Pfizer), 20 percent (Merck KGaA, Darmstadt, Germany) profit sharing on the product starting in 2016. The co-promotion term will last through December 31, 2020 for the United States, Canada, Japan, France, Germany, Italy, Spain and the United Kingdom, and from January 1, 2016 through December 31, 2021 in China and Turkey. Pfizer will report the sales of XALKORI in countries where it is co-promoted with Merck KGaA, Darmstadt, Germany.

"We are proud and excited to share the legacy of XALKORI, a medicine that changed the treatment paradigm for patients with ALK-positive metastatic NSCLC, with Merck KGaA, Darmstadt, Germany," said Liz Barrett, president and general manager, Pfizer Oncology. "Through our co-promotion of XALKORI, we will establish a best-in-class global sales organization that will be exceptionally prepared for the potential launches of our future oncology medicines."

"As we progress our robust program to co-develop and co-commercialize avelumab, the co-promotion agreement is an exciting milestone for the alliance between Merck KGaA, Darmstadt, Germany, and Pfizer, allowing us to establish our combined oncology sales organization in key markets for the program," said Dr. Andrew Schiermeier, head of Global Oncology and general manager for the Alliance for Merck KGaA, Darmstadt, Germany, adding: "For Merck KGaA, Darmstadt, Germany, this agreement is particularly important as it accelerates the establishment of our United States and Canada oncology sales organization ahead of our potential avelumab launches and positions us for future success in this market."

This co-promotion relationship is related to the announcement in November 2014 of a global strategic alliance between Merck KGaA, Darmstadt, Germany, and Pfizer to jointly develop and commercialize avelumab, an investigational anti-PD-L1 monoclonal antibody, to accelerate the development of immuno-oncology medicines for patients with cancer. The immuno-oncology alliance will also advance Pfizer’s PD-1 antibody.

About Non-small Cell Lung Cancer

Globally, lung cancer is the most common cause of cancer-related deaths in men and the second most common in women, responsible for almost twice as many deaths as both breast and prostate cancer combined1. Non-small cell lung cancer is the most common type of lung cancer, accounting for 85 to 90 percent of all lung cancers2. Locally advanced and metastatic disease account for approximately 35 to 40 percent3 and 70 percent4 of patients, respectively with NSCLC.

About XALKORI (crizotinib)

XALKORI is a kinase inhibitor indicated in the US for the treatment of patients with metastatic non-small cell lung cancer whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. The US indication is not limited to any specific line of therapy. In the EU, XALKORI is indicated for the treatment of adults with previously treated ALK-positive advanced NSCLC. XALKORI has received approval in more than 80 countries.

XALKORI Important Safety Information

Hepatotoxicity: Drug-induced hepatotoxicity with fatal outcome occurred in 0.2% of patients treated with XALKORI across clinical trials (n=1225). Transaminase elevations generally occurred within the first 2 months of treatment. Monitor with liver function tests including ALT and total bilirubin every 2 weeks during the first 2 months of treatment, then once a month and as clinically indicated. Permanently discontinue for ALT or AST elevation greater than 3 times ULN with concurrent total bilirubin elevation greater than 1.5 times ULN (in the absence of cholestasis or hemolysis), otherwise temporarily suspend and dose reduce XALKORI as indicated.

Pneumonitis: Severe, life-threatening, or fatal interstitial lung disease (ILD)/pneumonitis can occur in patients treated with XALKORI. Across clinical trials (n=1225), 2.5% of XALKORI-treated patients had any grade ILD, 0.9% of patients had Grade 3 or 4, and 0.5% had fatal cases. These cases generally occurred within 2 months after the initiation of treatment. Monitor patients for pulmonary symptoms indicative of pneumonitis. Exclude other causes and permanently discontinue XALKORI in patients with drug related pneumonitis.

QT Interval Prolongation: QTc prolongation can occur in patients treated with XALKORI. Across clinical trials (n=1225), QTc prolongation (all grades) was observed in 2.7% of patients and QTc greater than 500 ms on at least 2 separate ECGs occurred in 1.4% of patients. Avoid use of XALKORI in patients with congenital long QT syndrome. Consider periodic monitoring with electrocardiograms and electrolytes in patients who have a history of or predisposition for QTc prolongation, or who are taking medications that prolong the QT interval. Permanently discontinue XALKORI in patients who develop QTc greater than 500 ms or greater than or equal to 60 ms change from baseline with Torsade de pointes, polymorphic ventricular tachycardia, or signs/symptoms of serious arrhythmia, otherwise temporarily suspend and dose reduce XALKORI as indicated.

Bradycardia: Symptomatic bradycardia can occur in patients receiving XALKORI. Across clinical trials, bradycardia with a heart rate less than 50 beats per minute occurred in 11% of patients treated with XALKORI (n=1174). Monitor heart rate and blood pressure regularly. Avoid using XALKORI in combination with other agents known to cause bradycardia to the extent possible. Permanently discontinue for life-threatening bradycardia due to XALKORI; however, if associated with concomitant medications known to cause bradycardia or hypotension, hold XALKORI until recovery to asymptomatic bradycardia or to a heart rate of 60 bpm or above. If concomitant medications can be adjusted or discontinued, restart XALKORI at 250 mg once daily with frequent monitoring. Otherwise temporarily suspend and resume or dose reduce XALKORI as indicated.

Embryofetal Toxicity: XALKORI can cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised to avoid becoming pregnant while receiving XALKORI. If the patient or their partner becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus.

Adverse Reactions: Safety was evaluated in a phase 3 study in patients with ALK-positive metastatic NSCLC randomized to XALKORI (n=172) or chemotherapy (n=171). Serious adverse reactions were reported in 37.2% patients treated with XALKORI. The most frequent serious adverse reactions reported in patients treated with XALKORI were pneumonia (4.1%), pulmonary embolism (3.5%), dyspnea (2.3%), and ILD (2.9%). Fatal adverse reactions in XALKORI-treated patients occurred in 9 (5%) patients, consisting of: acute respiratory distress syndrome, arrhythmia, dyspnea, ILD, pneumonia, pneumonitis, pulmonary embolism, respiratory failure, and sepsis. Common adverse reactions occurring in ≥25% included vision disorder (diplopia, photophobia, photopsia, vision blurred, visual acuity reduced, visual impairment, vitreous floaters), diarrhea, nausea, vomiting, constipation, edema, decreased appetite, fatigue, upper respiratory infection, and dysgeusia. Grade 3 or 4 events occurring at a higher incidence with XALKORI than with chemotherapy and at greater than 2% incidence were syncope (3%), QT prolongation (3%), and pulmonary embolism (5%). Elevation of ALT of any grade occurred in 76% of patients and grade 3 or 4 in 17% of patients. Neutropenia of any grade occurred in 49% of patients and grade 3 or 4 in 12% of patients. Lymphopenia of any grade occurred in 51% of patients and grade 3 or 4 in 9% of patients. Renal cysts occurred in 4% and neuropathy in 19% of patients treated with XALKORI.

Drug Interactions: Exercise caution with concomitant use of moderate CYP3A inhibitors. Avoid grapefruit or grapefruit juice which may increase plasma concentrations of crizotinib. Avoid concomitant use of strong CYP3A inducers and inhibitors. Dose reduction may be needed for coadministered drugs that are predominantly metabolized by CYP3A.

Nursing Mothers: Given the potential for serious adverse reactions in nursing infants, consider whether to discontinue nursing or discontinue XALKORI.

Hepatic Impairment: XALKORI has not been studied in patients with hepatic impairment. As crizotinib is extensively metabolized in the liver, hepatic impairment is likely to increase plasma Crizotinib concentrations. Use caution in patients with hepatic impairment.

Renal Impairment: Administer XALKORI at a starting dose of 250 mg taken orally once daily in patients with severe renal impairment (CLcr<30 mL/min) not requiring dialysis. No starting dose adjustment is needed for patients with mild and moderate renal impairment.

For more information and full prescribing information, please visit www.XALKORI.com.

Clovis Oncology Receives Breakthrough Therapy Designation for Rucaparib for Monotherapy Treatment of Advanced Ovarian Cancer in Patients with BRCA-mutated Tumors (Inclusive of both Germline and Somatic BRCA Mutations)

On April 6, 2015 Clovis Oncology reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for the Company’s investigational agent rucaparib as monotherapy treatment of advanced ovarian cancer in patients who have received at least two lines of prior platinum-containing therapy, with BRCA-mutated tumors, inclusive of both germline BRCA (gBRCA) and somatic BRCA (sBRCA) mutations (Press release, Clovis Oncology, APR 6, 2015, View Source [SID:1234502943]).

Rucaparib is an oral, potent inhibitor of PARP1 and PARP2 being developed for the treatment of platinum-sensitive ovarian cancer, specifically in patients with tumors with BRCA mutations and other DNA repair deficiencies beyond BRCA, commonly referred to as "BRCA-like" or "BRCAness." The Breakthrough Therapy designation was granted based on interim efficacy and safety results from two ongoing Phase 2 studies of rucaparib in ovarian cancer, including a Phase 2 study in women with gBRCA mutations, and the ARIEL2 treatment study.

A clinical data update from the ARIEL2 study presented last week at the 2015 Annual Meeting on Women’s Cancer demonstrated that seventy percent (16/23) of evaluable BRCA-mutant patients achieved a RECIST and/or CA-125 response, and 65% (15/23) achieved a RECIST response. Responses were observed in both germline and somatic BRCA-mutant tumors.

"It is a distinct achievement for a company our size to have been granted Breakthrough Therapy designation for two separate products under development, and especially in less than one year," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "In the case of rucaparib, we believe it is in recognition of the encouraging response rate observed in women with BRCA-mutated advanced ovarian cancer treated with rucaparib, and this designation reinforces the unique profile of rucaparib among PARP inhibitors, as well as our leadership in the differentiated clinical development of a PARP inhibitor. This includes prospectively demonstrating meaningful activity in an additional group of advanced ovarian cancer patients whose tumors are not mutant BRCA, but whose tumors possess similar DNA repair deficiencies that behave like BRCA mutations. Rucaparib is the only PARP inhibitor to have shown activity in this broader, but still selected, patient population."

"Women with ovarian cancer are in need of better therapeutic options, and there is great focus on the potential of PARP inhibitors; data presented to date in mutant BRCA patients treated with rucaparib are very encouraging, as is the Breakthrough Therapy designation conferred by the FDA," said Robert L. Coleman, MD, Professor & Deputy Chairman, Vice Chair, Clinical Research, Ann Rife Cox Chair in Gynecology, Department of Gynecologic Oncology and Reproductive Medicine at University of Texas MD Anderson Cancer Center in Houston and one of the two principal investigators of the ARIEL3 study. "I am very enthusiastic about the substantive progress made by Clovis with both rucaparib and its patient selection tool that appears to be moving beyond BRCA to efficiently identify responder versus non-responder populations. Continuing successful development of this drug and its companion diagnostic will be a huge advance for women with this disease. Importantly, these data suggest that the majority of women tested might benefit from rucaparib treatment. We hope that the ARIEL2 extension study in around 300 women, and the randomized ARIEL3 trial in 540 women, will offer definitive support both for rucaparib and the companion diagnostic."

A clinical data update from the ARIEL2 study presented last week at the 2015 Annual Meeting on Women’s Cancer demonstrates encouraging activity and safety in women with advanced, platinum-sensitive ovarian cancer with gBRCA and sBRCA mutations. Seventy percent (16/23) of evaluable BRCA-mutant patients achieved a RECIST and/or CA-125 response, and 65% (15/23) achieved a RECIST response. Responses were observed in both germline and somatic BRCA-mutant tumors. In addition, data presented last week further demonstrate that Clovis’ proprietary BRCA-like DNA signature, run by its partner Foundation Medicine, successfully predicts which ovarian cancer patients respond to rucaparib therapy. In patients with normal BRCA genes, rucaparib activity was substantially higher for those with the prospectively-defined BRCA-like HRD signature versus biomarker negative patients. Forty-eight percent (12/25) of patients with the BRCA-like signature achieved a RECIST and/or CA-125 response, and 40% (10/25) achieved a RECIST response. In biomarker negative patients, few responses were observed: eight percent (1/13) of patients achieved a RECIST and/or CA-125 response.

These data also demonstrate that rucaparib is well-tolerated. At the recommended Phase Two dose of 600mg BID, the most common treatment-related adverse events (AEs) reported in ≥15 percent of all patients (n=121) included nausea, fatigue, transient ALT/AST elevations, dysgeusia, constipation, anemia/low hemoglobin, decreased appetite, vomiting and diarrhea. These events were mostly Grade 1/2; the only common grade 3/4 toxicity was anemia/low hemoglobin.

The next update of rucaparib clinical data, including outcomes data on the complete Part One ARIEL2 patient population, will be presented in an oral presentation at the 2015 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in late May/early June.

ARIEL Pivotal Study Program

The ARIEL (Assessment of Rucaparib in Ovarian Cancer Trial) program is a novel, integrated translational-clinical program designed to accurately and prospectively identify patients with tumor genomics associated with benefit from rucaparib therapy.

The global ARIEL2 study, initiated in Q4 2013, has completed enrollment of 206 ovarian cancer patients with relapsed, platinum-sensitive disease. The single-arm, open-label Phase 2 study is designed to prospectively test molecular features that predict sensitivity to rucaparib using DNA sequencing to evaluate each patient’s tumor. ARIEL2 was recently expanded into a registration study (the ARIEL2 extension), which will include an additional approximately 300 women with recurrent disease after at least three prior lines of chemotherapy, and data from this study are planned to serve as the basis of a New Drug Application (NDA) filing for the treatment of ovarian cancer in 2016.

The global ARIEL3 pivotal study is currently enrolling a total of 540 patients, in a randomized, double-blind Phase 3 study that compares the effects of rucaparib versus placebo. The study will evaluate whether maintenance rucaparib treatment in platinum-sensitive, high-grade ovarian cancer patients can extend the period of time for which a response to a prior chemotherapy is maintained. Efficacy is assessed in a pre-specified step-down manner, first in tumor BRCA-mutant patients, then in a larger group of patients with the BRCA-like signature, and finally in all randomized patients. The Company anticipates completing enrollment in the study within the next year.

In addition to the ARIEL program in ovarian cancer, the Company is exploring rucaparib in other solid tumor types with significant BRCA and BRCA-like populations including breast, gastroesophageal and pancreatic.

About Breakthrough Therapy Designation

The Breakthrough Therapy designation was enacted as part of the 2012 FDA Safety and Innovation Act and is intended to expedite development and review of drugs to treat serious or life-threatening medical conditions when preliminary clinical evidence demonstrates that the drug may have substantial improvement on at least one clinically significant endpoint over available therapies. Breakthrough Therapy designation includes all the features of the Fast Track designation, as well as more intensive guidance from the FDA on a drug’s clinical development program.

About Rucaparib

Rucaparib is an oral, potent inhibitor of PARP1 and PARP2 being developed for the treatment of platinum-sensitive ovarian cancer in patients with BRCA mutations (genes that are linked to breast and ovarian cancers) and other DNA repair deficiencies. For information about rucaparib studies in ovarian cancer, please visit www.arielstudy.com.

About Ovarian Cancer

Over 90% of ovarian cancer arises from the uncontrolled growth and replication of epithelial cells which form the surface of the ovary. Cancer involving this type of cell is known as epithelial ovarian cancer. High grade serous carcinoma is a subtype of epithelial ovarian cancer accounting for approximately 70 percent of cases. If detected at a very early stage, ovarian cancers can usually be removed surgically and this can be potentially curative. However, there are often no clearly identifiable initial symptoms and in approximately 90 percent of high grade serous ovarian cancer cases, the cancer has spread to other parts of the body before a person is diagnosed.