Spherium Biomed enrolls first patient in efficacy trial for SP13004 for prevention & treatment of chemoradiation-induced mucositis

By: PRLog
The Phase IB-II clinical trial is designed to investigate the safety, tolerability, pharmacokinetics and efficacy of SP13004 for the prevention and treatment of oral mucositis in patients with head and neck cancer undergoing chemoradiation.

SP13004 is a proprietary, high density gel containing melatonin (HD Melatonin©) to be used in mouth washes several times a day. In preclinical animal models it has shown promising results based on a novel, protective effect on the mucosa at local level

BARCELONA, Spain - Nov. 17, 2015 - PRLog -- Spherium Biomed announced today the enrollment of the first patient in a double-blind, placebo controlled efficacy trial of SP13004 for the prevention of mucositis in patients with head and neck cancer undergoing chemoradiation. The clinical trial initially involves clinical sites at four leading hospitals in Spain, and will include up to 84 patients. Luis Ruiz-Avila, Spherium Biomed’s CEO, shared that “SP13004 represents a unique opportunity to improve the quality of life for these patients, since most of them will develop oral mucositis as a side effect of their treatment.”

Mucositis is a painful inflammation/ulceration of the mucous membranes lining the digestive tract. Mucositis can occur anywhere along the gastrointestinal (GI) tract, but oral mucositis (OM) refers to the particular inflammation and ulceration that occurs in the mouth. Mucositis can also occur in the larynx, pharynx, esophagus, and even in the GI tract. Severe OM is associated with significant morbidities (Grade III reduces oral intake, increases the use of pain medication, and Grade IV can result in radio and/or chemotherapy dose reduction, hospitalization and parenteral nutrition) and impact on health economics.

More than 600,000 people/year are affected by the condition in Europe and in the United States;   with 95% of head and neck cancer receiving radiotherapy and 78% of patients with hematological cancers receiving bone marrow or stem cell transplantation (HSCT) likely to develop oral mucositis. Patients are currently treated with local anesthetic washes, hygiene procedures, anti-inflammatories or opioids; nevertheless mucositis is still recognized by oncologists and radiologists as a significant unmet medical need.

SP13004 is based on a seminal observation from Dr. Germaine Escame’s research at the University of Granada. Dr. Escames discovered a key protective role of melatonin at the local level in the mucosa. Melatonin, known for its hormone-like, sleep-regulating properties, also exerts a potent antioxidant and anti-inflammatory effect in the mucosal cells. The concentration of melatonin in these cells is more than 100 fold higher than in the pineal gland and blood. There is a natural, endogenous melatonin system that protects the mucosal tissue from external insults. This system is affected by the chemo-radiation protocols used to treat head and neck cancer, thus leading to mucositis. SP13004 is a proprietary, dense, adherent gel formulation of melatonin (HD-Melatonin©) which restores the natural levels of melatonin in the mucosa after topical exposure. This effect cannot be achieved from systemic exposure through the blood or by using mouth washes with regular solutions or gels.

Spherium Biomed aims to complete the clinical trial and to deliver top line results by the first half of 2017.

About Spherium (www.spheriumbiomed.com)

Spherium Biomed is a clinical-stage, biopharmaceutical portfolio company that sources its pipeline from academic sources. The company acts as an advanced project incubator with the ultimate goal of reaching a relevant value milestone in order to increase the chance of academic discoveries reaching the market.  The company applies its broad experience in drug development (from discovery to clinical and commercial stages) to deeply analyze the commercial potential of technologies. After defining the relevant gaps with respect to an ideal target product profile, the company derives a creative and cost-effective work plan to bring the project forward, and implements the plan with its own resources and the proactive coordination of external providers.

Spherium is privately owned; its major shareholders are its founders and key executives, and the Spanish pharmaceutical company Ferrer (www.ferrer.com). Its current portfolio includes four projects which will begin clinical efficacy trials before the end of 2016 and several first-in-class preclinical projects expected to show proof of concept during 2016-2017. The company is constantly looking for new opportunities addressing unmet clinical needs.

For more information please contact info@spheriumbiomed.com

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