On January 11, 2016 Incyte Corporation (Nasdaq:INCY) and AstraZeneca (NYSE:AZN) reported a new collaboration to evaluate the efficacy and safety of Incyte’s Janus-associated kinase (JAK) 1 inhibitor, INCB39110, in combination with AstraZeneca’s next generation epidermal growth factor receptor (EGFR) inhibitor, Tagrisso (osimertinib) (Press release, Incyte, JAN 11, 2016, View Source [SID:1234508720]). The combination will be assessed as a second-line treatment for patients with EGFR mutation-positive non-small cell lung cancer (NSCLC), who have been treated with a first generation EGFR tyrosine kinase inhibitor (TKI) and subsequently developed the T790M resistance mutation.

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There is increasing evidence that signaling through the JAK-STAT (signal transducer and activator of transcription) pathway could be a contributing factor in resistance to EGFR TKI treatment in patients with EGFR mutation NSCLC. Blocking both JAK and EGFR activity may therefore offer an improved targeted treatment benefit in some patients.

Under the terms of the agreement, AstraZeneca and Incyte will collaborate on a Phase 1/2 study, to be conducted by Incyte. The Phase 1 part of the trial is expected to establish a recommended dose regimen for the combination of INCB39110 and Tagrisso while the Phase 2 part of the study will assess the safety and efficacy profile. Results from the study will be used to determine whether further clinical development of this combination is warranted.

"The expansion of our research collaboration with AstraZeneca will allow us to further our understanding of these two compounds and explore their potential synergies both of which support our goal of delivering innovative medicines that will benefit patients with cancer or other diseases," said Rich Levy, MD, Chief Drug Development Officer, Incyte. "We look forward to adding to our ongoing clinical research for INCB39110 and exploring the potential of this combination."

"We are pleased to be building on our existing relationship with Incyte and exploring a potentially exciting combination for lung cancer patients who have developed a resistance to first generation EGFR inhibitor treatment," said Antoine Yver, Head of Oncology, Global Medicines Development at AstraZeneca. "This collaboration allows us to explore further ways in which Tagrisso, our first-in-class T790M-directed tyrosine kinase inhibitor, can help meet urgent unmet patient need, following its accelerated approval in the U.S. and the recent positive CHMP opinion, recommending approval in Europe."

This agreement builds on an existing collaboration between the two companies, announced in May 2014, to explore AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor, durvalumab, in combination with Incyte’s oral indoleamine dioxygenase-1 (IDO1) inhibitor, epacadostat (INCB24360).

About INCB39110
INCB39110 is an orally bioavailable, isoform-selective inhibitor of Janus-associated kinase 1 (JAK1). JAK1 activity is believed to play an important role in both autoimmune and oncologic diseases. JAK1 forms heterodimeric complexes with JAK2, JAK3 or TYK2 and functions as an immunomodulatory and inflammatory signalling kinase. Selective JAK1 inhibition prevents STAT signaling downstream of a number of cytokines, including IL-6, IL-10 and interferon-gamma. Consistent with the dominant role for JAK1 in mediating heterodimeric JAK/STAT signaling, JAK1 inhibition has been shown to result in equivalent efficacy compared to balanced JAK1/JAK2 modulation in a variety of preclinical solid and liquid tumor models. INCB39110 will be investigated in clinical trials as monotherapy in graft versus host disease (GvHD) and in several combination-based therapeutic regimens, including with PI3Kδ (INCB50465), IDO1 (epacadostat) and EGFR (Tagrisso) inhibitors.

About Tagrisso (osimertinib)
Tagrisso (osimertinib) is the only approved medicine indicated for adult patients with metastatic EGFR T790M mutation-positive non-small cell lung cancer. This indication is approved under the FDA’s accelerated approval process based on tumour response rate and duration of response (DoR). Osimertinib is being compared with platinum-based doublet chemotherapy in the confirmatory AURA3 Phase III study in patients with EGFR T790M-positive, locally advanced, or metastatic NSCLC who have progressed after EGFR-TKI therapy. It is also being investigated in the adjuvant and metastatic first-line settings, including in patients with brain metastases, and in combination with other compounds.

Non-clinical in vitro studies have demonstrated that osimertinib has high potency and inhibitory activity against mutant EGFR phosphorylation across the range of clinically relevant EGFRm and T790M mutant NSCLC cell lines, with significantly less activity against EGFR in wild-type cell lines.

On January 11, 2016 Incyte Corporation (Nasdaq: INCY) reported significant and rapid progress in its continued transformation into a leading global biopharmaceutical company (Press release, Incyte, JAN 11, 2016, View Source [SID:1234508719]). With two new programs expected to enter the clinic in the coming months, Incyte will have 13 development molecules in pivotal and proof-of-concept trials across a variety of oncology and non-oncology indications, illustrating the power of Incyte’s drug discovery and development engine.

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"We are experiencing a revolution in the way cancer is treated, and Incyte is at the forefront of innovation in drug discovery," said Hervé Hoppenot, President and Chief Executive Officer, Incyte. "Our rich portfolio of small molecules and biologics places us in a unique position. We have significant optionality to investigate these candidates alone as well as in combination as we continue our mission to deliver medicines that will positively impact the lives of patients with cancer and other diseases."

Presentation Highlights

JAK Inhibitors
The Phase 3 JANUS 1 trial of ruxolitinib, a JAK1 / JAK2 inhibitor, in second line metastatic pancreatic cancer is now fully recruited, with results expected in 2016. The primary endpoint of JANUS 1 is overall survival. Two Phase 2 trials of ruxolitinib, in colorectal and breast cancer, are now fully recruited, with overall survival data expected from both in 2016.

Incyte has two selective JAK1 inhibitors in clinical development, INCB39110 and INCB52793. A clinical collaboration has been initiated to investigate the safety and efficacy of the combination of INCB39110 with AstraZeneca’s next generation EGFR inhibitor Tagrisso (osimertinib)* in patients with EGFRm non-small cell lung cancer with the T790M mutation. Incyte’s second JAK1 selective inhibitor, INCB52793, is in a dose escalation study in patients with advanced malignancies. INCB52793 has shown synergistic efficacy in combination with standard of care in preclinical models of multiple myeloma.

Building upon positive, published third-party data of ruxolitinib from an investigator-sponsored trial in graft versus host disease (GVHD), a proof-of-concept trial of INCB39110 for the treatment of patients with GVHD has begun.

Each of the four pivotal trials of baricitinib, a JAK1 / JAK2 inhibitor licensed by Incyte to Eli Lilly and Company, met the primary endpoint in patients with rheumatoid arthritis. Lilly is finalizing the submissions of a New Drug Application (NDA) to the FDA and a Marketing Authorization Application (MAA) to the European Medicines Agency. Both will trigger milestone payments from Lilly to Incyte.

IDO1 Inhibitor
The ECHO (Epacadostat Clinical development in Hematology and Oncology) program has been designed to investigate combinations of Incyte’s IDO1 inhibitor, epacadostat, across the full cycle of anti-tumor immunity, including with checkpoint blockade, vaccines and other modulators of the tumor immune response.

The Phase 3 ECHO-301 study evaluating the combination of epacadostat with the anti-PD-1 antibody Keytruda (pembrolizumab)* for the first-line treatment of patients with advanced or metastatic melanoma is expected to begin in the first half of 2016. Recruitment has also begun into the eight tumor-specific cohorts of ECHO-202, the Phase 2 trial of epacadostat in combination with pembrolizumab.

Incyte is conducting three additional Phase 1/2 clinical trials of epacadostat in combination with immune checkpoint inhibitors. ECHO-204, in combination with Bristol-Myers Squibb’s PD-1 inhibitor, Opdivo (nivolumab)*, has opened seven tumor specific cohorts, and ECHO-203 with AstraZeneca/MedImmune’s investigational PD-L1 inhibitor, durvalumab, has opened six tumor specific cohorts. ECHO-110, a trial in combination with Roche/Genentech’s investigational PD-L1 inhibitor, atezolizumab, in patients with NSCLC is ongoing.

Selected Portfolio Updates
Incyte’s PI3Kδ inhibitor clinical development program is focused on INCB50465, based on the molecule’s potential lack of hepatotoxicity and improved potency compared to approved PI3Kδ inhibitors and compared to Incyte’s PI3Kδ inhibitor INCB40093. A Phase 1/2 trial of INCB50465, both as monotherapy and in combination with INCB39110, is already underway in multiple B-cell malignancies. Clinical activities of INCB40093 are being closed.

Incyte is also pursuing a series of clinical studies to investigate the safety and efficacy of several therapeutic doublets. These include a clinical trial of Incyte’s JAK1 inhibitor, INCB39110, in combination with either its IDO1 inhibitor, epacadostat, or its PI3Kδ inhibitor, INCB50465, as well as a trial of Merck’s anti-PD-1 antibody, pembrolizumab, in combination with either Incyte’s PI3Kδ inhibitor, INCB50465, or its JAK1 inhibitor, INCB39110.

Two new compounds are expected to enter Incyte’s clinical development portfolio in the first half of 2016. INCB59872, a potent and selective LSD1 inhibitor, is expected to enter clinical trials in patients with advanced malignancies in the coming months. INCAGN1876, an anti-GITR agonist antibody that is part of the ongoing discovery alliance with Agenus, Inc, is expected to enter clinical trials for the treatment of patients with advanced cancer during the first half of 2016. Incyte’s alliance with Agenus has recently been expanded to include a total of 7 therapeutic targets, with options for additional expansion.

Corporate Update
In January 2016, Michael Morrisey joined Incyte Europe Sàrl and the Incyte Executive Management team as Corporate Senior Vice President and Head of Global Technical Operations. Michael has extensive manufacturing experience and has excelled in building manufacturing organizations, most recently as Corporate Vice President, Head of International Technical Operations at Celgene International.

Webcast Information
A presentation made by Incyte at the 34th Annual J.P. Morgan Healthcare Conference will be webcast live today at 1:30pm PT / 4:30pm ET and can be accessed within the Investors section of www.incyte.com under Events and Presentations. Investors interested in listening to the live webcast should log on before the start time in order to download any software required. The slide deck and a replay of the presentation will also be made available following the presentation.

On January 11, 2016 Five Prime Therapeutics, Inc. (Nasdaq: FPRX), a clinical-stage biotechnology company focused on discovering and developing novel protein therapeutics for cancer and inflammatory diseases, reported an update on GlaxoSmithKline’s (GSK) ongoing Phase 1b clinical trial of FP-1039/GSK3052230, an FGF ligand trap, in patients with squamous non small cell lung cancer (sqNSCLC) and mesothelioma (Filing, 8-K, Five Prime Therapeutics, JAN 11, 2016, View Source [SID:1234508716]).

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GSK presented preliminary clinical safety and efficacy data from the Phase 1b trial at the World Conference on Lung Cancer on September 9, 2015. At the time, data from Arm A in treatment-naïve squamous sqNSCLC patients were encouraging, Arm B in second line sqNSCLC had few patients enrolled, and data from Arm C were immature because few mesothelioma patients were then evaluable. Based on preliminary data, GSK and Five Prime have agreed to continue to enroll up to 30 mesothelioma patients at the expansion dose of 15 mg/kg in Arm C of the trial. GSK plans to submit data for presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2016 Annual Meeting in June. The companies have also agreed to stop enrolling the sqNSCLC patient study cohorts given the change in treatment paradigms following approvals of immuno-oncology agents and the increasingly competitive landscape.

"We are encouraged by the preliminary data we have recently reviewed from the mesothelioma arm of the study and look forward to seeing the results as additional patients are enrolled and followed," said Lewis T. "Rusty" Williams, M.D., Ph.D., president and chief executive officer of Five Prime. "The majority of mesothelioma tumors express high levels of FGF-2, so our FGF ligand trap represents a rational therapeutic approach, and patients currently have limited treatment options. If we see similar results once we have full, mature data for Arm C, we will seek to regain rights for FP-1039 in the U.S., Canada and the E.U. from GSK, as mesothelioma could represent a potentially attractive market opportunity for Five Prime."

About the Phase 1b Trial
The Phase 1b clinical trial of FP-1039 is being conducted by GSK and is designed as a three-arm, multicenter, non-randomized, parallel-group, uncontrolled, open-label trial. This clinical trial was designed to evaluate the safety, tolerability, dosage, response rate and duration of response of FP-1039:

• in combination with paclitaxel and carboplatin in previously untreated metastatic sqNSCLC (Arm A);

• in combination with docetaxel in metastatic sqNSCLC that has progressed after previous therapy (Arm B); or

• in combination with front-line pemetrexed and cisplatin in mesothelioma (Arm C), a tumor in which the FGF-2 ligand is overexpressed.

About FP-1039
FP-1039 is a protein drug designed to intervene in FGF signaling. As a ligand trap, FP-1039 binds to FGF ligands circulating in the extracellular space (such as FGF-2), preventing these signaling proteins from reaching FGFR1 on the surface of tumor cells where they would otherwise stimulate cancer cell division and/or angiogenesis. However, FP-1039 does not bind to certain "hormonal" FGFs, including FGF-23, which regulates phosphate levels in the blood. As a result, treatment with FP-1039 treatment has not been shown to cause hyperphosphatemia, a side effect seen with small molecule inhibitors of FGF receptors, which block the activity of both cancer-associated FGFs and FGF-23.

About Mesothelioma
Mesothelioma is a disease with high unmet medical need and high mortality rate. A majority of mesothelioma patients have tumors with abnormally high levels of FGF-2. In preclinical testing, Five Prime observed inhibition of mesothelioma tumor growth with single-agent FP-1039. Mesothelioma is an orphan indication in the United States with a prevalence of about 4,000 patients and incidence of about 3,000 patients. Worldwide, there are a total of approximately 14,000 cases of mesothelioma diagnosed each year.

On January 11, 2016 CTI BioPharma Corp. (CTI BioPharma) (NASDAQ and MTA: CTIC) reported positive progress of its lead clinical program in addition to several key business priorities for 2016 (Press release, CTI BioPharma, JAN 11, 2016, View Source [SID:1234508713]).

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"After a productive 2015, we have entered 2016 well capitalized and focused on preparing for the potential accelerated approval and launch of a new treatment option for people with intermediate and high-risk myelofibrosis with low platelet counts," said James A. Bianco, M.D., CTI BioPharma’s President and Chief Executive Officer. "With the recently completed NDA submission for pacritinib, interim data indicating the potential therapeutic utility for tosedostat in AML and high-risk MDS, and a strong financial position, we believe the stage is set for a transformational year for our company."

Recent Progress Update

Pacritinib

In January 2016, CTI BioPharma announced the completion of the rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for pacritinib, an investigational oral kinase inhibitor with specificity for JAK2, FLT3, IRAK1 and CSF1R. CTI BioPharma and Baxalta Incorporated (Baxalta) are seeking U.S. marketing approval of pacritinib for the treatment of patients with intermediate and high-risk myelofibrosis with low platelet counts of less than 50,000 per microliter (<50,000/µL).

In December 2015, researchers presented results from a new analysis of the pivotal Phase 3 trial, PERSIST-1, evaluating pacritinib versus best available therapy, excluding treatment with JAK2 inhibitors (BAT), in patients with myelofibrosis. Data examining patient outcomes across baseline demographic factors that are associated with prognosis showed that treatment with pacritinib resulted in consistent rates of spleen volume reduction and control of disease-related symptoms across all intermediate or high-risk myelofibrosis subgroups.

Tosedostat

In December 2015, researchers presented an update on results from an investigator-sponsored Phase 2 trial of tosedostat – CTI BioPharma’s investigational oral selective aminopeptidase inhibitor – in elderly patients with either primary (de novo) acute myeloid leukemia (AML) or secondary AML. The data showed a complete response (CR) of 48.5 percent with tosedostat in combination with low dose cytarabine/Ara-C (LDAC) – 33 percent of these patients were still responding after a median of 506 days.

In November 2015, CTI BioPharma announced that the United Kingdom’s National Cancer Research Institute (NCRI) Haematological Oncology Clinical Studies Group has chosen to advance tosedostat to the second stage of a randomized clinical trial of low-dose cytarabine plus or minus tosedostat in older patients with AML or high risk myelodysplastic syndrome (MDS). The AML Less Intensive (LI-1) trial is designed as a "Pick-a-Winner" trial to be able to simultaneously test a number of promising agents added to standard therapy with low-dose cytarabine in older patients with AML or MDS who are unfit for standard aggressive induction therapy. Nine regimens have been tested in the Pick-a-Winner program, of which only four, including tosedostat, have passed the initial hurdle for progression (which requires evidence of an improvement in remission rate with acceptable safety). CTI BioPharma plans to discuss potential approval pathways with regulators in the U.S. and EU in 2016.

Corporate and Financial

In December 2015, the Company announced receipt of a $10 million milestone payment from Teva Pharmaceutical Industries Ltd. related to the achievement of sales milestones for TRISENOX (arsenic trioxide).

In September 2015, the Company completed a registered direct offering and in October and December 2015, the Company completed two underwritten public offerings resulting in aggregate net proceeds of approximately $115 million. CTI BioPharma’s current cash balance is anticipated to fund operations for at least the next two years based on our current budget expectations and development plans.

CTI BioPharma plans to provide 2016 financial guidance in its fourth quarter and year-end 2015 financial results announcement.

2016 Key Objectives

Seek U.S. regulatory approval and launch pacritinib. CTI BioPharma seeks U.S. marketing approval of pacritinib for the treatment of patients with intermediate and high-risk myelofibrosis with low platelet counts of <50,000/µL.

Complete enrollment and report PERSIST-2 topline results. CTI BioPharma expects to complete enrollment in the PERSIST-2 Phase 3 trial of pacritinib for patients with myelofibrosis whose platelet counts are less than or equal to 100,000 per microliter in the first quarter 2016 and unblind and report top-line data late in the fourth quarter of 2016.

Initiate trial in second indication for pacritinib. CTI BioPharma intends to advance a pacritinib development program in other hematologic malignancies in the fourth quarter of 2016.

Initiate registration-directed trial for tosedostat. CTI BioPharma plans to consult with the FDA and European Medicines Agency (EMA) regarding a registration-directed strategy for tosedostat, including the potential to utilize the results from the ongoing investigator-sponsored LI-1 trial to support registration and approval. If positive, these discussions could help enable the start of a pivotal program in 2016.

Secure ex-U.S. partner for tosedostat. CTI BioPharma intends to secure a partnership for the development and commercialization of tosedostat in certain territories outside the U.S.

Complete enrollment in PIX306. CTI BioPharma expects to complete enrollment in the ongoing PIX306 post-marketing commitment Phase 3 study of PIXUVRI in the fourth quarter of 2016.

On January 11, 2015 Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE: CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs being developed to treat inflammatory diseases, cancer and sexual dysfunction reported its anticipated clinical milestones for calendar year 2016 (Filing, 6-K, Can-Fite BioPharma, JAN 11, 2016, View Source [SID:1234508712]).

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Q1 2016 Rheumatoid Arthritis Phase III EMA Submission for CF101

In the first quarter of 2016, Can-Fite plans to file its Phase III protocol with the European Medicines Agency (EMA) for CF101 in the treatment of rheumatoid arthritis. Initiation of patient enrollment is anticipated in the second or third quarter of 2016. Can-Fite recently filed a trial protocol with the institutional review board (IRB) of Barzilai Medical Center in Israel, one of the planned clinical sites for the international trial to be conducted in Israel, Europe, Canada and the U.S. The Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study will investigate the efficacy and safety of CF101 administered orally twice daily for 16 weeks to patients with active rheumatoid arthritis treated with conventional drugs. The study will have three arms, a 1 mg CF101 dose, a 2 mg CF101 dose, and placebo, given orally twice daily in the form of tablets. Approximately 456 patients are expected to be enrolled in the study. According to Visiongain, the global rheumatoid arthritis market is forecasted to reach $38.5 billion by 2017.

H1 2016 Psoriasis Phase III EMA Submission for CF101

Can-Fite is now completing the design of its Phase III study protocol for CF101 in the treatment of psoriasis which the Company plans to file with the EMA in the first half of 2016 and anticipates initiating patient enrolment in the fourth quarter of 2016. The Company previously reported positive data from further analysis of its completed Phase II/III study that suggests CF101 as a potential systemic therapy for patients with moderate-severe psoriasis, this despite the study not meeting its primary endpoint. The psoriasis drug market is forecast to grow to $8.9 billion by 2018, according to estimates of Visiongain.

H1 2016 Liver Cancer Phase II Completion of Patient Enrollment for CF102

Can-Fite anticipates completing enrollment of approximately 78 patients during the first half of 2016, in its Phase II trial for CF102 in the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer. The randomized, double-blind, placebo controlled trial is being conducted in the U.S., Europe and Israel. CF102 received Fast Track Designation from the U.S. FDA as a second line treatment for HCC in patients who have previously received Nexavar (sorafenib). The drug has Orphan Drug Status in the U.S. and in Europe for the treatment of HCC. CF102 is approved for Compassionate Use for liver cancer by Israel’s Ministry of Health. According to Global Industry Analysts the global market for liver cancer was projected to exceed $2 billion by 2015.

Q2 2016 NASH Phase II Study Protocol Submission to IRBs for CF102

Can-Fite plans to file a Phase II study protocol with IRBs for its first human clinical study of CF102 in the treatment of non-alcoholic steatohepatitis (NASH), a new indication identified by the Company for its liver cancer drug. In November 2015, Can-Fite announced compelling pre-clinical data on CF102 in the treatment of NASH, a disease for which no FDA approved therapies currently exist. By 2025, Deutsche Bank estimates the addressable pharmaceutical market for NASH will reach $35-40 billion in size.

Q2 2016 Glaucoma Phase II Data Report for CF101

Can-Fite expects data from its Phase II study of CF101 in the treatment of glaucoma to be reported during the second quarter. Enrollment of 88 patients was recently completed in the study which is being conducted in two European countries and Israel by Can-Fite’s subsidiary OphthaliX Inc. The treatment market for glaucoma in the seven major markets is estimated to reach approximately $3 billion by 2023 according to GlobalData and CF101 is one of only a few oral drugs being developed for glaucoma. The market currently consists primarily of generic eye drop drugs. Oral administration is expected to improve patient compliance.

Q4 2016 Sexual Dysfunction IND/Phase I Study Filing with U.S. FDA for CF602

Can-Fite has an active pre-clinical development program for its next generation drug CF602 in the treatment of sexual dysfunction and is currently developing a working plan to file an investigational new drug (IND) application with the U.S. FDA for a Phase I study during the fourth quarter of 2016. Can-Fite received positive pre-clinical data from experimental animal models demonstrating that CF602 improved sexual dysfunction in a dose dependent manner. GlobalData estimates the value of the erectile dysfunction therapeutic market to be approximately $2.6 billion by 2018 with few drugs on the market which includes Viagra, Cialis and Levitra.

"We are very encouraged by the clinical and preclinical data from each of our drugs to date which indicate their efficacy across six major indications. We are moving towards initiating pivotal Phase III trials in two autoimmune diseases. As we look forward to announcing Phase II results for glaucoma and completing Phase II enrollment for liver cancer, we are preparing to enter human clinical studies in two new indications, NASH and sexual dysfunction. We expect 2016 will be a very active year," stated Can-Fite CEO Dr. Pnina Fishman.