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CYCLOPHARM LIMITED — Regulatory Filings 2012
Nov 18, 2012
64741_rns_2012-11-18_a99bfd83-417c-4ed2-8bb1-997d46a2362b.pdf
Regulatory Filings
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19 November 2012 The Manager Company Announcements Office Australian Securities Exchange Limited 20 Bridge Street Sydney NSW 2000
cyclo medica cyclo pet molecular imaging Technegas
Cyclopharm Ltd ABN 74 116 931 250 Bldg 75 Business & Technology Park New Illawarra Road Lucas Heights NSW 2234 Australia POB 350 Menai Central NSW 2234 T 61 2 9541 0411 F 61 2 9543 0960
TECHNEGAS CLINICAL TRIAL – FIRST PATIENT ENROLLED
The Directors of Cyclopharm Limited (ASX: CYC) are pleased to announce that the Technegas Clinical trial required for market entry into the United States has commenced.
The first patient study to be enrolled and imaged under the United States Food and Drug Administration (USFDA) approved protocol was conducted at the Presbyterian/Columbia University Medical Center located in New York City, New York.
A total of 750 patients are required for the study. It is expected that the multicenter trial will take upwards to 18 months to complete.
I look forward to updating our shareholders as we achieve each significant milestone towards USFDA approval.
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James McBrayer
Managing Director, CEO and Company Secretary
Contact details:
Mr James McBrayer Managing Director, CEO and Company Secretary Cyclopharm Limited Mobile: +61 (0)418967073
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Background
Cyclopharm Limited
Cyclopharm is a radiopharmaceutical company servicing the global medical community. The Company’s mission is to provide nuclear medicine and other clinicians with the ability to improve patient care outcomes.
Cyclopharm achieves this objective through the provision of radiopharmaceutical products, Technegas (for lung imaging) and Molecular Imaging / PET radiopharmaceuticals (used in cancer, brain and cardiac imaging). Our customers are nuclear medicine departments located within hospitals and clinics.
Technegas
The Technegas technology is a structured ultra-fine dispersion of radioactive labeled carbon, produced by using dried Technetium-99m in a carbon crucible, micro-furnaced for a few seconds at around 2,700[o] C. The resultant gaseous substance is inhaled by the patient (lung ventilation) via a breathing apparatus, which then allows multiple views and tomography imaging under a gamma or single photon emission computed tomography (SPECT) camera for the superior diagnosis of pulmonary emboli (blood clots in the lungs).
Positron Emission Tomography (PET)
PET radiopharmaceuticals target specific tissues / organs, concentrate there, and the attached radioisotope emits radiation, which is then detected by a PET or PET / CT gamma (collectively PET camera). These imaging modalities help physicians improve their ability to detect and determine the location, extent and stage of cancer, neurological disorders and cardiac disease. By improving diagnosis, PET scans aid physicians in selecting better courses of treatment, as well as assessing whether treatment is effective or should be changed.
Cyclopet, a wholly owned division of Cyclopharm, owns and operates a cyclotron facility located at Macquarie University Hospital. This facility licensed by the Australian Therapeutic Goods Authority (TGA) manufactures under Good Manufacturing Practices (GMP) radiopharmaceuticals used in PET diagnostic procedures.
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