Milan, Italy: BMG PHARMA S.r.l announces the issue of results of clinical studies related to its proprietary products GelX oral Gel and GelX Oral Spray.

November 9th 2015

BMG Pharma S.r.l. is pleased to announce the publication of results of clinical studies related to GelX® Oral Gel and GelX® Oral Spray.

GelX® Oral Gel and GelX ® Oral Spray are proprietary products of BMG Pharma Srl, Thanks to its innovative formulas,

the GelX® range alleviates pain in oncological patients, offering different solutions for chemotherapy & radiation induced oral mucositis.

Both products have mechanical action indicated for the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing the lesions caused by chemotherapy and/or radiation therapy. They form an adherent barrier and cover the oral mucosa lesions, thus protecting the sensitive nerves endings and lubricating the oral tissue.

These assumptions have been confirmed by three different clinical trials, one run in Italy on Gel and Spray) and two in Romania (on Spray only).

· During the Italian study (Ospedale Salvini, Rho, Milano) 40 patients with solid tumors and undergoing cisplatinum/5FU containing chemotherapy, chemo-radiation therapy and radiation therapy have been recruited. After one month from the end of treatment 30 patients had a complete resolution of pain and swelling alteration, 8 patients no pain but loss of swelling and 2 patients had mild pain and loss of swelling. Presented as poster at AIOM Congress, Rome, 23rd-25th October, 2015

· During the first Romanian study a total of 15 patients (children treated with chemotherapy for hematologic malignant diseases) were enrolled, 8 in the prophylactic arm (using Gelx Oral Spray)  and 7 in the curative arm.  Results showed better improvement in the prophylactic arm for: mouth pain, oral intake and saliva consistency. Presented as poster at ECC Congress, Wien, 20th-23rd June, 2015.

· During the second Romanian study (Institute of Oncology, Bucharest, Romania) 15 patients aged between 5-16 years and developing severe mucositis (grade 3) have been enrolled.  The study evaluated the grade of oral mucositis by WHO scale, pain, swallowing and eating difficulty during each chemotherapy cycle, comparing with mucositis symptoms from previous cycles treated with the same therapeutic measures but without GelX® Oral Spray. The study demonstrated that severity of OM was improved, duration of mucositis wash shorter after GelX® in treatment, swallowing and eating difficulties were reduced, there were no delays in treatment caused by severity of OM and no complications related to neutropenia occurred.
Presented as poster at the ECC congress, Wien, 25th -29th September, 2015.

About BMG
BMG is a specialty pharmaceutical company with head office in Milan, Italy, leveraging its proprietary technology to develop products that address unmet needs of patients. The company is currently focused on cancer supportive care, dermatology gynecology, ENT and oral health. BMG Pharma. is dedicated to helping patients, pharmacists and physicians by providing valuable and innovative products to the market.

The Company’s key features are:

  • Full involvement in business and partnering
  • Presence in different therapeutic areas
  • Specific regulatory strategies for each product as Prescription and OTC Medical Devices in EC and US to allow rapid market introduction. BMG focuses on bringing products to market quickly with supportive clinical data.
  • IP protection for most of the products and technologies

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BMG Pharma S.r.l.