Oscotec shares rebound on launch of US clinical trial

On December 11, 2017 Oscotec reported that shares of Oscotec rebounded on the company’s announcement that it has launched a clinical trial in the U.S. on SKI-G-801, a treatment for acute myeloid leukemia (AML) (Press release, Oscotec, DEC 11, 2017, View Source [SID1234573544]).

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The biotech company said in a public regulatory filing on Monday that its phase-1 clinical trial on SKI-G-801 will begin at six U.S. hospitals.

Oscotec’s shares, which had slid since Dec. 4, rebounded to 10,250 won ($9.4) as of noon on Monday, up 150 won from the previous trading day. Compared with early this year’s stock price of 7,390 won per share, it was up 38 percent.

SKI-G-801 is a treatment that selectively inhibits fms-like tyrosine receptor kinase 3 (FLT3). The company hopes that the new drug candidate will lower side effects and recurrence rate, compared to existing chemotherapies.

The U.S. study will check safety and drug tolerance, after administering SKI-G-801 to recurring or non-reacting AML patients and raising doses in a phased way. The trial will also test the drug’s appropriate doses and efficacy in AML patients with FLT3 mutations.

"Compared to the existing FLT3 inhibitors, SKI-G-801 has excellent pharmacologic activation and long-acting efficacy. Besides, we confirmed its efficacy on FLT3 mutations, which existing inhibitors had no effectiveness, as well as in the drug-resistant environment," Oscotec said.

It went on to say,"If we confirm the safety, drug tolerance, and oncolytic efficacy in the clinical trial, we expect that we will be able to transfer our technology to a multinational pharmaceutical company."

In July 2015, Oscotec transferred its investigational non-small cell lung cancer therapy YH25448 to Yuhan Corp. under an income-sharing contract.

Oscotec’s revenue reached 3.25 billion won ($2.99 million) in the first three quarters this year, with an operating loss of 992 million won.

Its flagship product is InduCera, a material for bone transplant, which takes up about 30 percent of the total sales.

Oasmia Pharmaceutical receives marketing approval for Paclical® in Kazakhstan

On December 11, 2017 Oasmia Pharmaceutical AB (NASDAQ: OASM), a developer of a new generation of drugs within human and veterinary oncology, reported that it has received marketing approval for Paclical in Kazakhstan (Press release, Oasmia, DEC 11, 2017, View Source [SID1234556571]). Paclical is the first water-soluble cancer drug with paclitaxel to receive a market authorization. Paclical will be sold through Hetero Group and is planned to be launched during the first half of 2018.

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Paclical, which has the name Apealea in Europe, is a novel formulation of paclitaxel based on Oasmia’s proprietary XR17 technology. It was approved for treatment of epithelial ovarian cancer. XR17 is non-toxic and forms water soluble nanoparticles with paclitaxel.

"The relationship established this year with Hetero Group grows further according to our plan with this approval," says Julian Aleksov, Executive Chairman at Oasmia Pharmaceutical. "We are pleased to see this expansion into Kazakhstan, a country that we are confident will benefit from an additional and high-quality treatment now made available to physicians and patients. We look forward to Hetero’s work in generating sales in the region, and most importantly to Paclical making a difference in the lives of patients and their families."

10-Q/A [Amend] – Quarterly report [Sections 13 or 15(d)]

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10-Q/A [Amend] – Quarterly report [Sections 13 or 15(d)]

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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

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10-Q/A [Amend] – Quarterly report [Sections 13 or 15(d)]

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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

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