On November 27, 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 financial results for the nine months ended September 30, 2015 and updates on its drug development programs (Filing, 6-K, Can-Fite BioPharma, NOV 27, 2015, View Source [SID:1234508352]).

Clinical Development Program and Corporate Highlights Include:

● Fortifies Balance Sheet with $13.8 Million Fund Raise
During September 2015, Can-Fite closed on approximately $9 million in funding from institutional investors. As of September 30, 2015 Can-Fite had cash and cash equivalents of $14.46 million. In October the Company raised an additional $4.8 million.

● CF102 – Receives Fast Track Designation in U.S. & Orphan Drug Designation in Europe; Reports Compelling Preclinical Data and Files Patent for NASH
During, and immediately following, the third quarter of 2015, three significant events moved CF102’s clinical development forward. 1) The U.S. Food and Drug Administration (FDA) granted Fast Track Designation to CF102 as a second line treatment for hepatocellular carcinoma (HCC), the most common form of liver cancer. With Fast Track CF102 benefits from more frequent meetings and communications with the FDA to review the drug’s development plan to support approval, while also allowing the Company to submit parts of the New Drug Application (NDA) on a rolling basis for review as data becomes available. CF102 also has the FDA’s Orphan Drug Designation. 2) In October 2015, the European Medicines Agency (EMA) granted Orphan Drug Designation to CF102 for the indication of HCC, giving CF102 protocol assistances and a 10-year market exclusivity following market approval in 28 EU member states and 3 additional European Economic Area countries. Can-Fite continues to enroll and dose patients in its global Phase II liver cancer study. Approximately 78 patients are expected to be enrolled in the trial in the U.S., Europe, and Israel by June 30, 2016. 3) In November 2015, the Company reported data from a preclinical study of an animal model of non-alcoholic steatohepatitis (NASH), revealing CF102 had a statistically significant reduction in liver pathology. This data supports the development of CF102 for NASH, which represents a large and unmet medical need, with no U.S. FDA approved treatment currently available. The addressable market for the treatment of NASH in 2025 is estimated at $35-$40 billion by Deutsche Bank. Can-Fite filed a patent for CF102 in the treatment of NASH.

● CF602 – Reports Mechanism of Action Study Data for Upcoming IND Submission
In October 2015, Can-Fite reported new findings for its CF602 drug candidate showing a defined mechanism of action in erectile dysfunction similar to sildenafil (Viagra) in a rat model of diabetes mellitus. CF602 demonstrated effects on erection superior to that of Viagra in animal studies. Viagra, sold by Pfizer, generated global sales of $1.685 billion in 2014. Can-Fite plans to file an Investigational New Drug (IND) application with the FDA for CF602 in the third quarter of 2016.

● CF101 – Preparing for Phase III trials in Rheumatoid Arthritis & Psoriasis
Can-Fite is currently preparing the protocol for its Phase III trial of CF101 in the treatment of psoriasis. Protocol design is scheduled for completion by the end of 2015. Having already completed the Phase III protocol for CF101 in the treatment of rheumatoid arthritis, Can-Fite plans to submit this protocol to Institutional Review Boards (IRBs) during in the fourth quarter of 2015. Marking an important step for CF101 prior to coming to market, "piclidenoson" was accepted as the drug’s proposed generic by the World Health Organization.

● Enrolling Patients in Ongoing Phase II Glaucoma Study by Can-Fite Subsidiary OphthaliX
OphthaliX continues to enroll patients in a Phase II clinical study of CF101 for glaucoma and data release is expected during the first half of 2016.

"During and immediately following the third quarter, we achieved regulatory milestones for CF102 that we believe will significantly accelerate our liver cancer drug’s time to market. Given the lack of effective medications for liver cancer, we are pleased that Fast Track designation in the U.S. and Orphan Drug designation in Europe are designed to expedite CF102’s pathway through advanced clinical trials and into market approval. NASH, another large and unmet medical need, has just emerged as a potential new indication for CF102 based on compelling new preclinical data," stated Can-Fite CEO Dr. Pnina Fishman. "We also very encouraged by the new mechanism of action data we reported for CF602 in sexual dysfunction. These animal studies demonstrated that CF602 produced erectile effects superior to Viagra and therefore we believe it has the potential to offer value in the market. We are currently preparing CF602’s IND for the indication of sexual dysfunction."

"As we look ahead to 2016, we are preparing to commence Phase III trials for CF101 in both psoriasis and rheumatoid arthritis. With a portfolio of indications that are all advancing towards market, we were pleased to fortify our balance sheet with $13.8 million from institutional investors," Dr. Fishman added.

Research and development expenses for the nine months ended September 30, 2015 were NIS 9.58 million (U.S. $2.44 million) compared with NIS 12.44 million (U.S. $3.17 million) for the same period in 2014. Research and developments expenses for the nine months of 2015 comprised primarily of expenses associated with the Phase II study for CF102 as well as expenses for ongoing studies of CF101. The decrease is primarily due to the completion of the Phase II/III psoriasis study during the first quarter of 2015 and a decrease in the scope of the non-clinical expenses during the first nine months of 2015 as compared to the parallel period in 2014.

General and administrative expenses were NIS 6.79 million (U.S. $1.73 million) for the nine months ended September 30, 2015 compared to NIS 7.73 million (U.S. $1.97 million) for the same period in 2014. The decrease is primarily due to a reduction in salary and professional services expenses.

Financial expenses, net for the nine months ended September 30, 2015 aggregated NIS 4.70 million (U.S. $1.20 million) compared to financial income, net of NIS 3.28 million (U.S. $0.84 million) for the same period in 2014. The increase in financial expenses, net in the nine months of 2015 was mainly due to an increase in the fair value of warrants that are accounted as financial liability.

Can-Fite’s net loss for the nine months ended September 30, 2015 was NIS 20.53 million (U.S. $5.23 million) compared with a net loss of NIS 16.89 million (U.S. $4.31 million) for the same period in 2014. The increase in net loss for the nine months of 2015, was primarily attributable to an increase in finance expenses, net offset by decreases in operating expenses.

As of September 30, 2015, Can-Fite had cash and cash equivalents of NIS 56.73 million (U.S. $14.46 million) as compared to NIS 36.09 million (U.S. $9.20 million) at December 31, 2014. The increase in cash during the nine months ended September 30, 2015 is due to NIS 32.35 million ($8.25 million) received from issuance of shares and warrants, net of issuance expenses and NIS 5.14 million (U.S. $1.31 million) received from Cipher Pharmaceuticals as upfront payment for entering into the distribution agreement with Cipher, offset by operating expenses. An additional $4.3 million, net was raised in October 2015, following the end of the third quarter.

For the convenience of the reader, the reported NIS amounts have been translated into U.S. dollars, at the representative rate of exchange on September 30, 2015 (U.S. $ 1 = NIS 3.923).

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The Company’s consolidated financial results for the nine months ended September 30, 2015 are presented in accordance with International Financial Reporting Standards.

On November 25, 2015 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the European Commission has approved CotellicTM (cobimetinib) for use in combination with Zelboraf (vemurafenib) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation (Press release, Hoffmann-La Roche , NOV 25, 2015, View Source [SID:1234508349]). The EU approval is based on data that showed Cotellic plus Zelboraf helped people with previously untreated BRAF V600 mutation-positive advanced melanoma live for more than a year without their disease worsening1.

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"There has been significant progress in the treatment of melanoma, with more medicines being approved in the past five years than in the previous 30," said Sandra Horning, M.D., Chief Medical Officer and Head of Global Product Development. "Together, Cotellic plus Zelboraf more strongly suppressed cancer growth than Zelboraf alone. This underscores the critical role of combination medicines in helping melanoma patients live longer without their disease worsening."

Today’s EU approval is based primarily on results of the Phase III coBRIM study, which showed that people with previously untreated BRAF V600 mutation-positive advanced melanoma who were being treated with the MEK inhibitor Cotellic in combination with Zelboraf lived a median of one year (12.3 months) without their disease worsening or death (progression-free survival; PFS) compared to 7.2 months with Zelboraf alone (hazard ratio [HR]=0.58; 95 percent confidence interval [CI] 0.46-0.72).1
The objective response rate (ORR) with the combination was 70 percent (16 percent complete response [CR], 54 percent partial response [PR]) compared to 50 percent (11 percent CR, 40 percent PR) in the Zelboraf arm.1 The safety profile of Cotellic plus Zelboraf was consistent with safety data previously reported. The most common adverse events in the combination arm were diarrhea, rash, nausea, fever, sun sensitivity, liver lab abnormalities, elevated creatine phosphokinase (CPK, an enzyme released by muscles) and vomiting.

Additional data were presented on November 21, 2015 at the Society for Melanoma Research congress demonstrating that the combination of Cotellic plus Zelboraf met its secondary endpoint of improving overall survival compared to Zelboraf alone. These data will be submitted to the European Medicines Agency for consideration and inclusion in the label. Cotellic in combination with Zelboraf is now approved in the EU and Switzerland for the treatment of people with BRAF V600 mutation-positive advanced melanoma. In the US, the combination is approved for the treatment of people with BRAF V600E or V600K mutation-positive advanced melanoma. Further country approvals are anticipated in 2016.

About the coBRIM study
CoBRIM is an international, randomised, double-blind, placebo-controlled Phase III study evaluating the safety and efficacy of 60 mg once daily of cobimetinib plus 960 mg twice daily of Zelboraf compared to 960 mg twice daily of Zelboraf alone. In the study, 495 patients with BRAF V600 mutation-positive unresectable locally advanced or metastatic melanoma (detected by the cobas 4800 BRAF Mutation Test) and previously untreated for advanced disease were randomised to receive Zelboraf every day on a 28-day cycle plus either cobimetinib or placebo on days 1-21. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent. Investigator-assessed PFS is the primary endpoint. Secondary endpoints include PFS by independent review committee, objective response rate, overall survival, duration of response and other safety, pharmacokinetic and quality of life measures2.

About Cotellic plus Zelboraf
Cotellic and Zelboraf are prescription medicines used in combination to treat melanoma that has spread to other parts of the body or cannot be removed by surgery, and that has a certain type of abnormal "BRAF" gene. Found in approximately half of melanomas3, mutated BRAF causes abnormal signaling inside certain cancer cells leading to tumor growth4,5. Zelboraf is designed to inhibit some mutated forms of BRAF and Cotellic is designed to inhibit some forms of MEK. Both BRAF and MEK are proteins in a cell signaling pathway that help control cell growth and survival6. When used in combination, Cotellic and Zelboraf are thought to reduce cancer cell growth longer than with Zelboraf alone. A patient’s healthcare provider will perform a test to make sure Cotellic and Zelboraf are right for the patient. Cotellic and Zelboraf are not used to treat melanoma with a normal BRAF gene. It is not known if Cotellic and Zelboraf are safe and effective in children under 18 years of age.

Cotellic is also being investigated in combination with several investigational medicines, including an immunotherapy, in several tumour types such as non-small cell lung cancer and colorectal cancer. Cotellic was discovered by Exelixis Inc. and is being developed by Roche in collaboration with Exelixis.

About melanoma
Melanoma is less common, but more aggressive and deadlier than other forms of skin cancer.7,8 BRAF is mutated in approximately half of melanomas.3 When melanoma is diagnosed early, it is generally a curable disease,9,10 but most people with advanced melanoma have a poor prognosis.8More than 232,000 people worldwide are currently diagnosed with melanoma each year.11 In recent years, there have been significant advances in treatment for metastatic melanoma and people with the disease have more options. However, it continues to be a serious health issue with a high unmet need and a steadily increasing incidence over the past 30 years.12

On November 25, 2015 Pfizer Inc. (NYSE:PFE) reported that the European Commission has approved a label update to expand use of XALKORI (crizotinib) to first-line treatment of adults with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) (Press release, Pfizer, NOV 25, 2015, View Source [SID:1234508364]). The Summary of Product Characteristics also has been updated to include efficacy data from PROFILE 1014, which demonstrated that XALKORI significantly prolonged progression-free survival (PFS) in previously untreated patients with ALK-positive advanced nonsquamous NSCLC when compared to standard platinum-based chemotherapy regimens.1

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"The European Commission’s decision to approve XALKORI in the first-line setting reinforces XALKORI’s role as a standard of care for patients with ALK-positive advanced NSCLC," said Andreas Penk, MD, regional president Oncology Europe, Africa and the Middle East, Head Greater China and Asia-Pacific Oncology Regions. "This milestone further underscores the importance of early and routine biomarker testing in patients with advanced NSCLC so that these patients can be identified and treated appropriately."

The European Commission’s approval of XALKORI follows the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, and is supported by the results from PROFILE 1014, a Phase 3 global, randomized, open-label, two-arm study evaluating the efficacy and safety of XALKORI in patients previously untreated for ALK-positive advanced nonsquamous NSCLC.1

XALKORI was the first ALK inhibitor approved by regulatory authorities in the United States (U.S.), EU, China and Japan, and it is now approved in more than 85 countries. XALKORI is widely recognized as a standard of care for patients with ALK-positive advanced NSCLC. To date, more than 20,000 patients have been treated with XALKORI worldwide.2

XALKORI is an oral, ALK inhibitor.3 By inhibiting the ALK fusion protein, XALKORI blocks signaling in a number of cell pathways that are believed to be critical for the growth and survival of tumor cells, which may lead to growth inhibition or regression of tumors.4,5

About Non-Small Cell Lung Cancer

Worldwide, lung cancer is the leading cause of cancer death in both men and women.6 NSCLC accounts for about 85 percent of lung cancer cases and remains difficult to treat, particularly in the metastatic setting.7 Approximately 57 percent of NSCLC patients are diagnosed late with metastatic, or advanced, disease where the five-year survival rate is only 5 percent.8

XALKORI (crizotinib) Indication and Important Safety Information (as per U.S. Prescribing Information)

XALKORI is a kinase inhibitor indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.

Hepatotoxicity: Drug-induced hepatotoxicity with fatal outcome occurred in 0.1% of patients treated with XALKORI across clinical trials (n=1669). Transaminase elevations generally occurred within the first 2 months. 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, with more frequent repeat testing for increased liver transaminases, alkaline phosphatase, or total bilirubin in patients who develop transaminase elevations. Permanently discontinue for ALT/AST elevation >3 times ULN with concurrent total bilirubin elevation >1.5 times ULN (in the absence of cholestasis or hemolysis); otherwise, temporarily suspend and dose-reduce XALKORI as indicated.

Interstitial Lung Disease (Pneumonitis): Severe, life-threatening, or fatal interstitial lung disease (ILD)/pneumonitis can occur. Across clinical trials (n=1669), 2.9% of XALKORI-treated patients had any grade ILD, 1.1% had Grade 3/4, and 0.5% had fatal ILD. These cases generally occurred within 3 months after initiation of treatment. Monitor for pulmonary symptoms indicative of ILD/pneumonitis. Exclude other potential causes and permanently discontinue XALKORI in patients with drug-related ILD/pneumonitis.

QT Interval Prolongation: QTc prolongation can occur. Across clinical trials (n=1560), 2.1% of patients had QTcF (corrected QT by the Fridericia method) ≥500 ms and 5.0% had an increase from baseline QTcF ≥60 ms by automated machine-read evaluation of ECG. Avoid use in patients with congenital long QT syndrome. Consider periodic monitoring with ECGs and electrolytes in patients with congestive heart failure, bradyarrhythmias, electrolyte abnormalities, or who are taking medications that prolong the QT interval. Permanently discontinue XALKORI in patients who develop QTc >500 ms or ≥60 ms change from baseline with Torsade de pointes, polymorphic ventricular tachycardia, or signs/symptoms of serious arrhythmia. Withhold XALKORI in patients who develop QTc >500 ms on at least 2 separate ECGs until recovery to a QTc ≤480 ms, then resume at a reduced dose.

Bradycardia: Symptomatic bradycardia can occur. Across clinical trials, bradycardia occurred in 12.3% of patients treated with XALKORI (N=1669). Avoid use in combination with other agents known to cause bradycardia. Monitor heart rate and blood pressure regularly. In cases of symptomatic bradycardia that is not life-threatening, hold XALKORI until recovery to asymptomatic bradycardia or to a heart rate of ≥60 bpm, re-evaluate the use of concomitant medications, and adjust the dose of XALKORI. 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. If concomitant medications can be adjusted or discontinued, restart XALKORI at 250 mg once daily with frequent monitoring.

Severe Visual Loss: Across clinical trials, the incidence of Grade 4 visual field defect with vision loss was 0.2% (N=1669). Discontinue XALKORI in patients with new onset of severe visual loss (best corrected vision less than 20/200 in one or both eyes). Perform an ophthalmological evaluation. There is insufficient information to characterize the risks of resumption of XALKORI in patients with a severe visual loss; a decision to resume should consider the potential benefits to the patient.

Vision Disorders: Most commonly visual impairment, photopsia, blurred vision or vitreous floaters, occurred in 62% of 1669 patients. The majority (95%) of these patients had Grade 1 visual adverse reactions. 0.8% of patients had Grade 3 and 0.2% had Grade 4 visual impairment. The majority of patients on the XALKORI arms in Studies 1 and 2 (>50%) reported visual disturbances which occurred at a frequency of 4-7 days each week, lasted up to 1 minute, and had mild or no impact on daily activities.

Embryofetal Toxicity: XALKORI can cause fetal harm when administered to a pregnant woman. Advise of the potential risk to the fetus. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment and for at least 45 days (females) or 90 days (males) respectively, following the final dose of XALKORI.

Adverse Reactions: Safety was evaluated in a phase 3 study in previously untreated patients with ALK-positive metastatic NSCLC randomized to XALKORI (n=171) or chemotherapy (n=169). Serious adverse events were reported in 34% of patients treated with XALKORI, the most frequent were dyspnea (4.1%) and pulmonary embolism (2.9%). Fatal adverse events in XALKORI-treated patients occurred in 2.3% of patients, consisting of septic shock, acute respiratory failure, and diabetic ketoacidosis. Common adverse reactions (all grades) occurring in ≥25% and more commonly (≥5%) in patients treated with XALKORI vs chemotherapy were vision disorder (71% vs 10%), diarrhea (61% vs 13%), edema (49% vs 12%), vomiting (46% vs 36%), constipation (43% vs 30%), upper respiratory infection (32% vs 12%), dysgeusia (26% vs 5%), and abdominal pain (26% vs 12%). Grade 3/4 reactions occurring at a ≥2% higher incidence with XALKORI vs chemotherapy were QT prolongation (2% vs 0%), and constipation (2% vs 0%). In patients treated with XALKORI vs chemotherapy, the following occurred: elevation of ALT (any grade [79% vs 33%] or Grade 3/4 [15% vs 2%]); elevation of AST (any grade [66% vs 28%] or Grade 3/4 [8% vs 1%]); neutropenia (any grade [52% vs 59%] or Grade 3/4 [11% vs 16%]); lymphopenia (any grade [48% vs 53%] or Grade 3/4 [7% vs 13%]); hypophosphatemia (any grade [32% vs 21%] or Grade 3/4 [10% vs 6%]). In patients treated with XALKORI vs chemotherapy, renal cysts occurred (5% vs 1%). Nausea (56%) decreased appetite (30%), fatigue (29%), and neuropathy (21%) also occurred in patients taking 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. Avoid concomitant use of CYP3A substrates with narrow therapeutic range in patients taking XALKORI. If concomitant use of CYP3A substrates with narrow therapeutic range is required in patients taking XALKORI, dose reductions of the CYP3A substrates may be required due to adverse reactions.

Lactation: Because of the potential for adverse reactions in breastfed infants, advise females not to breast feed during treatment with XALKORI and for 45 days after the final dose.

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.

(Filing, 10-K, Varian Medical Systems, NOV 25, 2015, View Source [SID:1234508351])

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On November 25, 2015 Cellceutix Corporation (OTC: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for Brilacidin-OM, an oral rinse formulation of the Company’s novel defensin-mimetic Brilacidin, for the prevention of oral mucositis (Press release, Innovation Pharmaceuticals, NOV 25, 2015, View Source [SID1234536591]). Oral mucositis, a common and often debilitating inflammation and ulceration that occurs in the mouth as a side-effect of certain cancer treatments, afflicts approximately 450,000 patients each year in the United States and can affect the course and outcome of cancer therapy. There are no FDA approved drugs for the prevention of oral mucositis.

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In an ongoing Phase 2 trial, Brilacidin-OM is being evaluated for its safety and efficacy in preventing oral mucositis in patients undergoing chemoradiation for the treatment of head and neck cancer. Seven clinical sites and two satellite sites are currently enrolling patients in the trial, with additional sites expected to open enrollment in the coming weeks.

The FDA established the Fast Track Designation process to facilitate the development, and expedite the review of, drugs that have the potential to treat serious and life threatening conditions and fill an unmet medical need. Drugs developed under the Fast Track program are afforded increased access to the FDA and could qualify for other programs to expedite development, including priority review and accelerated approval.

"Hundreds of thousands of patients suffer from oral mucositis each year, including many of the approximately 60,000 patients diagnosed with head and neck cancer, with no drug available to help prevent it," commented Leo Ehrlich, Chief Executive Officer at Cellceutix. "We are very optimistic about our defensin-mimetic franchise given the strong antibacterial properties of Brilacidin-IV shown in clinical trials for ABSSSI and lab studies demonstrating the anti-inflammatory and anti-biofilm properties of Brilacidin-OM, which we hope to validate in the Phase 2 trial in oral mucositis patients. The Fast Track Designation provides us a greater opportunity to interact with the FDA and the possibility of other programs to assist in hastening the development of Brilacidin-OM. With the Orphan Drug Designation for drug Kevetrin to treat retinoblastoma, an FDA meeting being scheduled at the beginning of 2016 for our planned Phase 2 trial of Kevetrin for ovarian cancer, which is also being developed under an Orphan Drug Designation, and now this Fast Track Designation for Brilacidin-OM, it’s been a solid month of developments with the FDA for our oncology pipeline."