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

KaloBios has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, KaloBios, 2018, MAR 27, 2018, View Source [SID1234525020]).

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

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

Celsion has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Celsion, 2018, MAR 27, 2018, View Source [SID1234524998]).

FENNEC PHARMACEUTICALS RECEIVES BREAKTHROUGH THERAPY DESIGNATION BY FDA FOR PEDMARK™

On March 27, 2018 Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has granted PEDMARK (a unique formulation of sodium thiosulfate) Breakthrough Therapy designation for prevention of cisplatin-related ototoxicity in pediatric patients with standard risk hepatoblastoma (SR-HB) (Press release, Fennec Pharmaceuticals, APR 27, 2018, View Source [SID1234525799]).

"The decision by the FDA to grant PEDMARK the first Breakthrough Therapy designation for the prevention of cisplatin ototoxicity reflects a recognition of the promising efficacy and safety data generated from SIOPEL 6 and COG ACCL0431 studies. We believe the recent receipt of Fast Track designation, and today, Breakthrough Therapy designation highlights the current lack of safe and effective treatments and overwhelming need to address this serious condition," said Rosty Raykov, President and Chief Executive Officer of Fennec. "This designation is another significant milestone for the advancement of PEDMARKTM, as we work closely with the Agency to expedite the NDA filing."

According to FDA, Breakthrough Therapy designation is given when preliminary clinical evidence has been provided to show that a treatment effect may represent substantial improvement over available therapies for the treatment of a serious condition. The designation includes all of the Fast Track program features, as well as more intensive FDA guidance on an efficient drug development program. Additional information is available under the FDA guidance for Industry Expedited Programs for Serious Conditions – Drugs and Biologics:

View Source

About PEDMARK (Sodium Thiosulfate (STS))

Cisplatin and other platinum compounds are essential chemotherapeutic components for many pediatric malignancies. Unfortunately, platinum-based therapies cause ototoxicity in many patients, and are particularly harmful to the survivors of pediatric cancer.

In the U.S. and Europe there is estimated that over 10,000 children may receive platinum based chemotherapy. The incidence of hearing loss in these children depends upon the dose and duration of chemotherapy, and many of these children require lifelong hearing aids. There is currently no established preventive agent for this hearing loss and only expensive, technically difficult and sub-optimal cochlear (inner ear) implants have been shown to provide some benefit. Infants and young children at critical stages of development lack speech language development and literacy, and older children and adolescents lack social-emotional development and educational achievement.

STS has been studied by cooperative groups in two Phase 3 clinical studies of survival and reduction of ototoxicity, The Clinical Oncology Group Protocol ACCL0431 and SIOPEL 6. Both studies are completed. The COG ACCL0431 protocol enrolled one of five childhood cancers typically treated with intensive cisplatin therapy for localized and disseminated disease, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, and medulloblastoma. SIOPEL 6 enrolled only hepatoblastoma patients with localized tumors.

Nagoya City University, Chubu University, Daiichi Sankyo and Mitsubishi UFJ Capital Announce Open Innovation Research on New Cancer Hyperthermia Therapy in Japan

On March 27, 2018 Public University Corporation Nagoya City University (Chairman: Kenjiro Kohri; Nagoya, Aiichi Prefecture; hereinafter, "Nagoya City University"), Chubu University, Incorporated Educational Institution Chubu University (President: Osamu Ishihara; Kasugai, Aichi Prefecture; hereinafter, "Chubu University"), Daiichi Sankyo Company, Limited (Representative Director, President and COO: Sunao Manabe; head office: Chuo-ku, Tokyo; hereinafter, "Daiichi Sankyo") and Mitsubishi UFJ Capital Co., Ltd. (President: Muneki Handa; head office: Chuo-ku, Tokyo; hereinafter "Mitsubishi UFJ Capital") reported that they will commence open innovation research ("the research") on a new cancer hyperthermia therapy*1 (Press release, Daiichi Sankyo, MAR 27, 2018, View Source [SID1234525387]).

Based on results of joint research under TaNeDS*2, an open competition joint discovery research grant program operated by Daiichi Sankyo, the research aims to find and optimize magnetic nanoparticles with high capacity for delivery into tumors, and then study their practical application as a new hyperthermia therapy for cancer treatment by researching an alternating magnetic field generating device for efficiently heating the particles.

To carry out the research, a new company called OiDE RYO-UN, Inc. (head office: Chuo-ku, Tokyo; hereinafter "RYO-UN") has been established and will be wholly funded by the OiDE Fund Investment Limited Partnership ("OiDE Fund") operated by Mitsubishi UFJ Capital.

If the pre-agreed goals of the three-year joint research are achieved, Daiichi Sankyo will purchase all of the stock of RYO-UN in order to continue research and development for the project on its own. Then, at the time of achieving its own goals and after a successful product launch, Daiichi Sankyo will pay considerations to Nagoya City University and Chubu University in the form of royalties.

The research on a new cancer hyperthermia treatment is the third OiDE Fund*3 investment, and Daiichi Sankyo and Mitsubishi UFJ Capital plan to continue to carry out open innovation projects to develop new drug discovery platforms using the OiDE Fund.

*1 New cancer hyperthermia therapy
Cancer hyperthermia therapy makes use of the characteristic that cancer cells have weaker heat resistance than normal cells. This therapy selectively kills cancer cells through heating and there are expectations that it can be combined with radiotherapy, chemotherapy and cancer immunotherapy. The new cancer hyperthermia therapy aims to achieve high safety and efficacy by specifically heating cancer cells at a constant temperature.

*2 TaNeDS
TaNeDS (Take a New Challenge for Drug diScovery) is a collaborative drug discovery initiative being pursued by Daiichi Sankyo in open innovation. This is an open competition joint discovery research grant program whose scope covers research from the exploratory stage to the pre-practical application stage.

*3 OiDE (Open innovation for the Development of Emerging technologies) Fund
A fund jointly established by Mitsubishi UFJ Capital and Daiichi Sankyo in 2013, and operated by Mitsubishi UFJ Capital