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Oasmia Pharmaceutical Reports Positive Results from Study on Weekly Administration of Apealea® (Paclical®)

Oasmia Pharmaceutical AB
Company Announcement

Oasmia Pharmaceutical Reports Positive Results from Study on Weekly
Administration of Apealea® (Paclical®)

Results from a dose-finding study with weekly administration of Apealea
(alternatively branded Paclical in some international regions) in patients with
metastatic breast cancer are now available.

Uppsala, Sweden, 2016-12-21 08:15 CET (GLOBE NEWSWIRE) --

Uppsala, Sweden, December 21, 2016 – Oasmia Pharmaceutical AB (NASDAQ: OASM), a
developer of a new generation of drugs within human and veterinary oncology,
today presented positive results from a recently completed dose-finding study
of weekly administration of Apealea (Paclical).

The study included 48 patients with metastatic breast cancer that were treated
weekly with Apealea (Paclical) starting at 100 mg/m2 and increasing in steps of
10 mg/m2 until 250 mg/m2 was reached. The pre-defined, dose-limiting toxicity
as defined in the study protocol was not reached until 250 mg/m2 per week. An
overall analysis of all adverse events recorded in the study defined 180 mg/m2
as the level for dose-limiting toxicity. The suggested dose for further
development of weekly administration of Apealea is 170 mg/m2.

29 patients continued in a follow-up study for an additional one (1) to 22
weekly cycle(s). Efficacy was assessed through computed tomography in 26
patients: one (1) had complete response, two (2) partial responses, and 23
stable disease. The remaining three (3) patients left the study due to
progressive disease. The safety assessments of the follow-up study confirmed
the dose of 170 mg/m2 as suitable for further development.

“We are pleased to present results indicating our dosing regime is becoming
increasingly accurate and tolerable for patients,” said Margareta Eriksson,
Vice President of Clinical Development at Oasmia Pharmaceutical. “This study
within the indication of breast cancer, one that affects so many women
worldwide, positions Apealea as having significant potential for both patients
as well as the physicians who treat them.”

Notes to editors:

About Oasmia Pharmaceutical AB
Oasmia Pharmaceutical AB develops, manufactures, markets and sells new
generations of drugs in the field of human and veterinary oncology. The
company’s product development aims to create and manufacture novel nanoparticle
formulations and drug-delivery systems based on well-established cytostatics
which, in comparison with current alternatives, show improved properties,
reduced side-effects, and expanded applications. The company’s product
development is based on its proprietary in-house research and company patents.
Oasmia is listed on NASDAQ Capital Markets (OASM.US), Frankfurt Stock Exchange
(OMAX.GR, ISIN SE0000722365) and NASDAQ Stockholm (OASM.ST).

Julian Aleksov, Executive Vice Chairman
Phone: +46 18 50 54 40

Författare SSE

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