1stOncology™: Cancer Intelligence Service – Page 15695 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Can-Fite Reports Financial Results for Six Months Ended June 30, 2016

On August 26, 2016 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 six months ended June 30, 2016 and updates on its drug development programs (Filing, Q2, Can-Fite BioPharma, 2016, AUG 26, 2016, View Source [SID:1234514753]).

Clinical Development Program and Corporate Highlights Include:

● Piclidenoson (CF101) – Upcoming Phase III Trials in Rheumatoid Arthritis & Psoriasis

Rheumatoid Arthritis: Can-Fite reached an agreement with the European Medicine Agency (EMA) on the protocol design of its upcoming Phase III trial of Piclidenoson in the treatment of rheumatoid arthrosis. Based on the suggestion of the EMA, Piclidenoson will be developed as a first line therapy and replacement for the current gold standard, Methotrexate (MTX), the most widely used drug for rheumatoid arthritis, a treatment market forecast to reach $38.5 billion by 2017. The planned Phase III trial will aim to show Piclidenoson is not inferior to MTX. Based on this clinical study design, Can-Fite is now conducting preparatory work for the trial including drug tableting, packaging and labeling work. The Company plans to submit its study protocol to the Institutional Review Boards (IRBs) of clinical sites in the first quarter of 2017.

Psoriasis: Can-Fite submitted a Phase III clinical trial protocol for Piclidenoson in the treatment of moderate-to-severe psoriasis with the EMA in the first half of 2016. Based on a pre-submission meeting the Company had with the EMA, the planned trial will be a head-to-head study comparing Piclidenoson to apremilast (Otezla), a recently approved oral drug from Celgene. Can-Fite expects a meeting with the EMA to discuss the trial’s design in the third quarter of 2016.

New mechanism of action data showing Piclidenoson may offer efficacy similar to industry-leading biologics, without the associated harmful side effects, were presented by Can-Fite at Psoriasis 2016, the 5th Congress of the Psoriasis International Network, in Paris, France. The oral presentation titled, "CF101 via A3AR Activation inhibits IL-17 and IL-23," was delivered on July 7, 2016.

The peer reviewed scientific journal, Journal of Drugs in Dermatology, published data from a Phase II/III trial of Piclidenoson in the treatment of moderate to severe psoriasis. The study titled, "Treatment of Plaque-Type Psoriasis With Oral CF101: Data from a Phase II/III Multicenter, Randomized, Controlled Trial," was published in August 2016.

● CF102 – Ongoing Phase II in Liver Cancer & Plans to Commence Phase II in NASH

Liver Cancer: Can-Fite continues to enroll and dose patients in its global Phase II study of CF102 in the treatment of hepatocellular carcinoma, the most common form of liver cancer. Enrollment of approximately 78 patients in the U.S., Europe, and Israel is expected to conclude in the second half of 2016.

NASH: Can-Fite worked with world renowned Key Opinion Leaders in the field of liver diseases to complete the protocol design for its upcoming Phase II trial of CF102 in the treatment of non-alcoholic fatty liver disease (NAFLD), the precursor to non-alcoholic steatohepatitis (NASH). By 2025, the addressable pharmaceutical market for NASH is estimated to reach $35-40 billion. The Company plans to file its protocol with IRBs in the second half of 2016.

● CF602 – Preparing for Phase I in the Treatment of Sexual Dysfunction

Can-Fite is currently conducting Investigational New Drug (IND) enabling studies of CF602 in the treatment of sexual dysfunction to support commencing a Phase I study in the first quarter of 2017. The Company presented data at the American Urology Association’s Annual 2016 Meeting in San Diego, California. The presentation titled, "CF602 Improves Erectile Dysfunction in Diabetic Rats," was delivered on May 10, 2016. CF602’s mechanism of action, its efficacy in increasing penile intracavernous pressure (ICP), and single dose efficacy were included in the presentation.

"In the first half of 2016, we were particularly encouraged by feedback received from the EMA, indicating we conduct head-to-head studies of Piclidenoson in psoriasis and rheumatoid arthritis. These studies will compare Piclidenoson to drugs that are used as the standard of care today. Because of Piclidenoson’s well established safety profile, proving efficacy that is equivalent to the comparative drugs would highlight the benefits of Piclidenoson in delivering a safe, effective and oral treatment," stated Can-Fite CEO Dr. Pnina Fishman. "In addition to heading into Phase III studies of Piclidenoson, we are pleased to continue the development programs of CF102 and CF602 to address unmet clinical needs."

Revenues for the six months ended June 30, 2016 were NIS 0.43 million (U.S. $0.11 million) compared to NIS 0.27 million (U.S. $0.07 million) in the first six months of 2015. The increase in revenue was due to the recognition of a portion of the NIS 5.14 million (U.S. $1.36 million) upfront payment received in March 2015 under the distribution agreement with Cipher Pharmaceuticals.

Research and development expenses for the six months ended June 30, 2016 were NIS 9.97 million (U.S. $2.59 million) compared with NIS 5.75 million (U.S. $1.5 million) for the same period in 2015. Research and development expenses for the first half of 2016 comprised primarily of expenses associated with the Phase II study for CF102, preclinical study for CF602, as well as expenses for ongoing studies of CF101. The increase is primarily due to costs associated with preparations of the CF101 Phase III studies in the treatment of rheumatoid arthritis and psoriasis.

General and administrative expenses were NIS 4.99 million (U.S. $1.3 million) for the six months ended June 30, 2016 compared to NIS 4.67 million (U.S. $1.21 million) for the same period in 2015. The increase is primarily due to an increase in share based compensation expense.

Financial income, net for the six months ended June 30, 2016 aggregated NIS 3.19 million (U.S. $0.83 million) compared to financial income, net of NIS 1.88 million (U.S. $0.49 million) for the same period in 2015. The increase in financial income, net in the first half of 2016 was mainly due to a larger decrease in the fair value of warrants that are accounted for as financial liability as compared to the same period in 2015. In addition, the increase in financial income, net in the first half of 2016 was attributable to a decrease in financial expenses due to exchange rate differences as compared to the same period in 2015.

Can-Fite’s net loss for the six months ended June 30, 2016 was NIS 11.35 million (U.S. $2.95 million) compared with a net loss of NIS 8.27 million (U.S. $2.15 million) for the same period in 2015. The increase in net loss for the first half of 2016 was primarily attributable to an increase in research and development expenses offset by an increase in financial income, net.

As of June 30, 2016, Can-Fite had cash and cash equivalents of NIS 46.42 million (U.S. $12.07 million) as compared to NIS 66.03 million (U.S. $17.17 million) at December 31, 2015. The decrease in cash during the six months ended June 30, 2016 is due to operating expenses.

For the convenience of the reader, the reported NIS amounts have been translated into U.S. dollars, at the representative rate of exchange on June 30, 2016 (U.S. $1 = NIS 3.846).

The Company’s consolidated financial results for the six months ended June 30, 2016 are presented in accordance with International Financial Reporting Standards.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

ANTICANCER AGENT “TREAKISYM(R) FOR INJECTION 100 MG” APPROVED IN JAPAN FOR ADDITIONAL INDICATION OF CHRONIC LYMPHOCYTIC LEUKEMIA

On August 26, 2016 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that the anticancer agent TREAKISYM for Injection 100 mg (generic name: bendamustine hydrochloride, "TREAKISYM") has been approved in Japan for an additional indication of chronic lymphocytic leukemia (Press release, Eisai, AUG 26, 2016, View Source [SID:1234514752]). TREAKISYM is the subject of a licensing agreement concluded between Eisai and SymBio Pharmaceuticals Limited (Headquarters: Tokyo, President & CEO: Fuminori Yoshida, "SymBio").

TREAKISYM was initially approved in Japan in October 2010 for relapsed or refractory low-grade B-cell non-Hodgkin’s lymphoma and mantle cell lymphoma. Under the licensing agreement concluded between the two companies, Eisai has been marketing the product in Japan since its launch in December 2010.

Symbio filed an application for this additional indication in December 2015 in response to a development request from the Japanese Ministry of Health, Labour and Welfare’s Study Group on Unapproved and Off Label Drugs with high unmet medical needs. Chronic lymphocytic leukemia is a blood cancer characterized by neoplastic transformation and excess propagation of lymphocytes, a type of white blood cell, in the bone marrow. With approximately 2,000 patients with chronic lymphocytic leukemia in Japan as well as an incidence rate of new cases of approximately 0.3 in 100,000, this is a disease with high unmet medical need. Furthermore, TREAKISYM has been designated as an orphan drug for chronic lymphocytic leukemia in Japan.

Eisai positions oncology as a key therapeutic area and is aiming to discovery revolutionary new medicines with the potential to cure cancer. Eisai remains committed to maximizing the value of TREAKISYM as well as its in-house developed anticancer agents including Halaven and Lenvima, seeking to contribute further to addressing the diverse needs of patients with cancer and their families.

1. About bendamustine hydrochloride (generic name, product name: TREAKISYM)
Bendamustine hydrochloride is an anticancer agent originally synthesized by German (formerly ‘East German’) pharmaceutical company Jenapharm and is marketed in Europe under the brand names Ribomustin and Levact as a treatment for non-Hodgkin’s lymphoma, multiple myeloma and chronic lymphocytic leukemia. In the United States the product has been approved by the U.S. Food and Drug Administration and is currently marketed under the brand name TREANDA for the treatment of chronic lymphocytic leukemia and relapsed indolent B-cell non-Hodgkin’s lymphoma. Eisai concluded an exclusive licensing agreement with SymBio in August 2008 concerning the joint development and marketing of TREAKISYM in Japan, which was followed by a subsequent agreement between the two companies in May 2009 concerning the development and marketing of the agent in Singapore and South Korea.
2. About TREAKISYM (additional parts have been underlined)
Product Name:
TREAKISYM for Injection, for intravenous infusion 100 mg
Generic Name:
Bendamustine Hydrochloride
Indications and Usage:
1. For the treatment of relapsed or refractory forms of the following diseases:
Low-grade B-cell non-Hodgkin’s lymphoma
Mantle cell lymphoma
2. Chronic lymphocytic leukemia
Dosage and Administration:
1. For relapsed or refractory low-grade B-cell non-Hodgkin’s lymphoma or mantle cell lymphoma

The usual adult dose of bendamustine hydrochloride is 120 mg/m2 body surface area infused intravenously over 60 minutes on Days 1 and 2 of repeated 21-day cycles. The dose may be reduced appropriately according to the patient’s condition.
2. For chronic lymphocytic leukemia

The usual adult dose of bendamustine hydrochloride is 100 mg/m2 body surface area infused intravenously over 60 minutes on Days 1 and 2 of repeated 28-day cycles. The dose may be reduced appropriately according to the patient’s condition.

Anti-Cancer Agent “Xeloda®,” Obtained Approval for Additional Indication of “Adjuvant Chemotherapy for Rectal Cancer”

On August 26, 2016 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it obtained a supplemental approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) on August 26, 2016, for the anti-cancer agent, capecitabine (brand name: Xeloda Tablets 300) for the indication of "adjuvant chemotherapy for rectal cancer (Press release, Chugai, AUG 26, 2016, View Source [SID:1234514751])." In Japan, Xeloda is currently on the market and its approved indications are "inoperable or recurrent breast cancer," "postoperative adjuvant chemotherapy for colon cancer," "advanced or refractory colorectal cancer, which is not amenable to curative resection" and "gastric cancer." With this supplemental approval, the indication of Xeloda has been changed to "colorectal cancer," covering the above indications for colon and colorectal cancer.

"Xeloda in adjuvant chemotherapy for rectal cancer is regarded as the standard of care in several guidelines," said Chugai’s Senior Vice President, Head of Project & Lifecycle Management Unit, Dr. Yasushi Ito. "In addition to the current approved indications, this supplemental approval enables people with locally advanced rectal cancer to use Xeloda as well. We believe it will encourage patients to receive treatment with hope and positive thoughts."

The "26th Review Committee on Unapproved Drugs and Indications with High Medical Needs"* held on February 3, 2016, evaluated whether "public knowledge-based application" might be applicable for Xeloda in adjuvant chemotherapy for rectal cancer. On February 26, the Second Committee on New Drugs, Pharmaceutical Affairs and Food Sanitation Council made a decision that filing through the "public knowledge-based application" was reasonable. Given that decision, Chugai filed for Xeloda through a "public knowledge-based application" on March 2 and obtained this supplemental approval.

Xeloda was developed by Nippon Roche K.K. (currently Chugai) and has been approved in more than 100 countries worldwide. Chugai strongly believes that Xeloda will make a contribution to patients as a treatment option for "colorectal cancer." Chugai will continue its efforts to contribute to cancer treatment.

* The "Review Committee on Unapproved Drugs and Indications with High Medical Needs" was established for the purpose of enhancing development by the pharmaceutical companies of drugs and indications that have been approved for use in western countries but not yet approved in Japan, through activities such as evaluating medical needs and confirming the applicability of "public knowledge-based application" and investigating the need for studies that should be additionally conducted.

Xeloda is a registered trademark of F. Hoffmann-La Roche, Ltd. (Switzerland)

[Drug Information]

Brand name: Xeloda Tablets 300

Generic name: Capecitabine

Indications: Inoperable or recurrent breast cancer
Colorectal cancer
Gastric cancer

Dosage and administration:
Regimens A or B are available for the treatment of inoperable or recurrent breast cancer. Regimen B should be employed in adjuvant chemotherapy for colorectal cancer, while regimen C should be employed in combination with another anticancer agent for the treatment of advanced or recurrent colorectal cancer which is not amenable to curative resection. Regimen D should be employed in adjuvant chemotherapy for rectal cancer in combination with radiation therapy. Regimen C should be employed in combination with a platinum agent for the treatment of gastric cancer.

Regimen A:
XELODA is administered orally in the following doses, according to body surface area, twice daily within 30 minutes after morning and evening meals for 21 consecutive days, followed by a 7-day rest period. The administration is repeated with this taken as one course.
Body surface area Each dose
<1.31m2 900mg
≥1.31 to <1.64m2 1,200mg
≥1.64m2 1,500mg
Regimen B:
XELODA is administered orally in the following doses, according to body surface area, twice daily within 30 minutes after morning and evening meals for 14 consecutive days, followed by a 7-day rest period. The administration is repeated with this taken as one course. The dosage should be reduced according to the patient’s condition.
Body surface area Each dose
<1.33m2 1,500mg
≥1.33 to <1.57m2 1,800mg
≥1.57 to <1.81m2 2,100mg
≥1.81m2 2,400mg
Regimen C:
XELODA is administered orally in the following doses, according to body surface area, twice daily within 30 minutes after morning and evening meals for 14 consecutive days, followed by a 7-day rest period. The administration is repeated with this taken as one course. The dosage should be reduced according to the patient’s condition.
Body surface area Each dose
<1.36m2 1,200mg
≥1.36 to <1.66m2 1,500mg
≥1.66 to <1.96m2 1,800mg
≥1.96m2 2,100mg
Regimen D:
XELODA is administered orally in the following doses, ac-cording to body surface area, twice daily within 30 minutes after morning and evening meals for 5 consecutive days, followed by a 2-day rest period. This is repeated. The dosage should be reduced according to the patient’s condition.
Body surface area Each dose
<1.31m2 900mg
≥1.31 to <1.64m2 1,200mg
≥1.64m2 1,500mg
Drug price: JPY 360.2/TabletAugust 26, 2016 — Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced today that it obtained a supplemental approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) on August 26, 2016, for the anti-cancer agent, capecitabine (brand name: Xeloda Tablets 300) for the indication of "adjuvant chemotherapy for rectal cancer." In Japan, Xeloda is currently on the market and its approved indications are "inoperable or recurrent breast cancer," "postoperative adjuvant chemotherapy for colon cancer," "advanced or refractory colorectal cancer, which is not amenable to curative resection" and "gastric cancer." With this supplemental approval, the indication of Xeloda has been changed to "colorectal cancer," covering the above indications for colon and colorectal cancer.

"Xeloda in adjuvant chemotherapy for rectal cancer is regarded as the standard of care in several guidelines," said Chugai’s Senior Vice President, Head of Project & Lifecycle Management Unit, Dr. Yasushi Ito. "In addition to the current approved indications, this supplemental approval enables people with locally advanced rectal cancer to use Xeloda as well. We believe it will encourage patients to receive treatment with hope and positive thoughts."

The "26th Review Committee on Unapproved Drugs and Indications with High Medical Needs"* held on February 3, 2016, evaluated whether "public knowledge-based application" might be applicable for Xeloda in adjuvant chemotherapy for rectal cancer. On February 26, the Second Committee on New Drugs, Pharmaceutical Affairs and Food Sanitation Council made a decision that filing through the "public knowledge-based application" was reasonable. Given that decision, Chugai filed for Xeloda through a "public knowledge-based application" on March 2 and obtained this supplemental approval.

Xeloda was developed by Nippon Roche K.K. (currently Chugai) and has been approved in more than 100 countries worldwide. Chugai strongly believes that Xeloda will make a contribution to patients as a treatment option for "colorectal cancer." Chugai will continue its efforts to contribute to cancer treatment.

* The "Review Committee on Unapproved Drugs and Indications with High Medical Needs" was established for the purpose of enhancing development by the pharmaceutical companies of drugs and indications that have been approved for use in western countries but not yet approved in Japan, through activities such as evaluating medical needs and confirming the applicability of "public knowledge-based application" and investigating the need for studies that should be additionally conducted.

Xeloda is a registered trademark of F. Hoffmann-La Roche, Ltd. (Switzerland)

[Drug Information]

Brand name: Xeloda Tablets 300

Generic name: Capecitabine

Indications: Inoperable or recurrent breast cancer
Colorectal cancer
Gastric cancer

Dosage and administration:
Regimens A or B are available for the treatment of inoperable or recurrent breast cancer. Regimen B should be employed in adjuvant chemotherapy for colorectal cancer, while regimen C should be employed in combination with another anticancer agent for the treatment of advanced or recurrent colorectal cancer which is not amenable to curative resection. Regimen D should be employed in adjuvant chemotherapy for rectal cancer in combination with radiation therapy. Regimen C should be employed in combination with a platinum agent for the treatment of gastric cancer.

Regimen A:
XELODA is administered orally in the following doses, according to body surface area, twice daily within 30 minutes after morning and evening meals for 21 consecutive days, followed by a 7-day rest period. The administration is repeated with this taken as one course.
Body surface area Each dose
<1.31m2 900mg
≥1.31 to <1.64m2 1,200mg
≥1.64m2 1,500mg
Regimen B:
XELODA is administered orally in the following doses, according to body surface area, twice daily within 30 minutes after morning and evening meals for 14 consecutive days, followed by a 7-day rest period. The administration is repeated with this taken as one course. The dosage should be reduced according to the patient’s condition.
Body surface area Each dose
<1.33m2 1,500mg
≥1.33 to <1.57m2 1,800mg
≥1.57 to <1.81m2 2,100mg
≥1.81m2 2,400mg
Regimen C:
XELODA is administered orally in the following doses, according to body surface area, twice daily within 30 minutes after morning and evening meals for 14 consecutive days, followed by a 7-day rest period. The administration is repeated with this taken as one course. The dosage should be reduced according to the patient’s condition.
Body surface area Each dose
<1.36m2 1,200mg
≥1.36 to <1.66m2 1,500mg
≥1.66 to <1.96m2 1,800mg
≥1.96m2 2,100mg
Regimen D:
XELODA is administered orally in the following doses, ac-cording to body surface area, twice daily within 30 minutes after morning and evening meals for 5 consecutive days, followed by a 2-day rest period. This is repeated. The dosage should be reduced according to the patient’s condition.
Body surface area Each dose
<1.31m2 900mg
≥1.31 to <1.64m2 1,200mg
≥1.64m2 1,500mg
Drug price: JPY 360.2/Tablet

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

(Filing, Annual, ImmunoGen, 2016, AUG 25, 2016, View Source [SID:1234514746])

8-K – Current report

On August 25, 2013, Soligenix, Inc. (the "Company") reported it entered into an agreement with SciClone Pharmaceuticals, Inc. ("SciClone"), pursuant to which SciClone provided the Company with access to its oral mucositis clinical and regulatory data library in exchange for exclusive commercialization rights for SGX942 (dusquetide), a novel, first-in-class therapy being developed by the Company for the treatment of oral mucositis in patients with head and neck cancer, subject to the negotiation of economic terms (Filing, 8-K, Soligenix, AUG 25, 2016, View Source [SID:SID1234515114]).

On September 9, 2016, the Company and SciClone entered into an exclusive license agreement (the "License Agreement"), pursuant to which the Company granted rights to SciClone to develop, promote, market, distribute and sell SGX942 in the People’s Republic of China, including Hong Kong and Macau, as well as Taiwan, South Korea and Vietnam (the "Territory"). Under the terms of the License Agreement, SciClone will be responsible for all aspects of development, product registration and commercialization in the Territory, having access to data generated by the Company. In exchange for exclusive rights, SciClone will pay to the Company royalties on net sales, and the Company will supply commercial drug product to SciClone on a cost-plus basis, while maintaining worldwide manufacturing rights.

In connection with the execution of the License Agreement, the Company entered into a common stock purchase agreement (the "Purchase Agreement") with SciClone pursuant to which the Company sold 3,529,412 shares of the Company’s common stock, par value $0.001 per share ("Common Stock"), to SciClone for $0.85 per share, for an aggregate price of $3,000,000. As additional consideration for expanded territorial rights in South Korea, Taiwan and Vietnam, SciClone agreed to purchase the shares of Common Stock at a premium above the current market price, with the purchase price being equal to one hundred thirty five percent (135%) of the average trading price of the Common Stock over the ten trading days prior to September 9, 2016. As part of the transaction, the Company granted SciClone certain demand registration rights.

The Purchase Agreement is provided to give investors information regarding the agreements’ respective terms. It is not provided to give investors factual information about the Company or SciClone. In addition, the representations, warranties and covenants contained in the Purchase Agreement were made only for purposes of that agreement and as of specific dates, were solely for the benefit of the parties to that agreement, and may be subject to limitations agreed by the contracting parties, including being qualified by disclosures exchanged between the parties in connection with the execution of such agreement. The representations and warranties may have been made for the purposes of allocating contractual risk between the parties to the agreement instead of establishing these matters as facts, and may be subject to standards of materiality applicable to the contracting parties that differ from those applicable to investors. Investors are not third-party beneficiaries under the agreement and should not view the representations, warranties and covenants or any descriptions thereof as characterizations of the actual state of facts or conditions of the Company.