SOURCE: Paxman Coolers Ltd.

Paxman Coolers Ltd.

August 19, 2015 10:00 ET

Paxman Cold Cap Chemotherapy Hair Loss Prevention Investigational Device -- Clinical Trials Expand to Second Dallas Oncology Center

DALLAS, TX--(Marketwired - August 19, 2015) - The U.S. clinical trials of a UK developed hair loss prevention system for early stage breast cancer patients have been expanded to an additional US Oncology Research site in Dallas.

A randomized trial of the Paxman scalp cooling (or cold cap) device, that is already used by more than 1,000 cancer treatment centers globally, is being expanded to Texas Oncology -- Medical City Dallas following its launch at a number of other cancer treatment centers in Texas.

The U.S. trial is the latest and largest clinical study to date by Paxman and follows numerous trials and approvals globally.

The device was originally developed by a British entrepreneur after his wife underwent chemotherapy in the 1990s. The Paxman device is now available in more than 80% of UK oncology centers with studies in many other countries.

Dr. Michael Savin, who is research site director and principal investigator at Texas Oncology-Medical City Dallas, will lead the trial at the new center.

"We are always keen to evaluate the latest investigational devices, and we are hopeful that the results of this device here in the U.S. will be promising for patients.

"We know that patients are independently taking measures to replicate aspects of this device, and we want to accurately assess just how effective the Paxman scalp cooler is with our patients here in Dallas, when the device is properly delivered and monitored," Dr. Savin added.

The investigational therapy works by cooling the scalp and reducing blood flow to the hair follicles in order to reduce or eliminate the resultant chemotherapy induced alopecia. The 'cold cap' scalp cooling device circulates liquid coolant through soft silicone scalp caps, worn before, during and after the administration of chemotherapy, in an attempt to prevent damage to patients' hair follicles.

The cap reduces the temperature of the patient's scalp by just a few degrees, and this study is intended to determine if it is effective in reducing or eliminating hair loss in certain patients.

The trials involve early stage breast cancer patients undertaking the scalp cooling therapy using the devices for an average of 2.5 hours during the administration of chemotherapy treatments.

Richard Paxman, Managing Director of Paxman Coolers and son of the firm's founder and CEO, commented on the expansion of the trial:

"This research study is the largest in our company's history, and we are working to extend the reach and availability of the trial to new centers in order to complete the trial by early 2016. The demand for scalp cooling treatments in the United States is huge, and we are working diligently to first establish its effectiveness and then hopefully go on to offer the currently experimental device to more women in America.

"The loss of hair associated with chemotherapy is a devastating side effect of cancer treatment, and we believe the resultant benefits of preventing or reducing hair loss offer huge improvements to a cancer patient's quality of life," he added.

To date, the trial has seen 85 women treated with the Paxman Orbis devices, with a further 150 suitable candidates needed to undertake the study to fill the trial requirements and allow for evaluation.

Eligible patients, namely: newly diagnosed breast cancer patients (stage I or II) who are undergoing at least four cycles of anthracycline or taxane based chemotherapy regimen, are offered use of the investigational device at no cost to themselves or their insurers, in exchange for private participation in the trial.

Since its first UK trials in 1997, Paxman Coolers have been used by 100,000 patients in 32 countries worldwide. Patients interested in learning more about U.S. trial eligibility should visit http://www.paxman-coolers.co.uk/multi-centre-us-trial/.

Trial Extended in Dallas.

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