Vicus Therapeutics, a privately held, biopharmaceutical company focused on developing oncology supportive care drug products, has completed the phase-2a clinical trial for cancer cachexia with its VT-122 drug.

The trial was carried out on 59 evaluable patients who have met defined inclusion criteria for the study. The trail was conducted at multiple sites across India including All India Institute of Medical Sciences (AIIMS), New Delhi. The human study spanned for period of one and half years. The duration of the study was 12 weeks per patient.

The entire study was done under a USIND regulatory framework. The company had outsourced the human study to leading clinical research organizations, Dr Nirupa Bareja, country director, India, Vicus Therapeutics told Pharmabiz.

VT-122 is one of the company's range of products which has completed the Phase 2a clinical trials for cancer cachexia. Other drugs VT-211 and VT-212, are in investigator-led pilot trials for chemotherapy-induced oral mucositis and neutropenia. The VT-310 is in pre-clinical evaluation for cancer-related fatigue.

The Vicus business model is based on re-purposing already existing safe, approved drugs for unmet medical needs in the oncology space. A high level science has been used to come up with this 'top-down' approach which is economical in terms of cost and time. The return on investment will be realized in an extremely short period of time, stated Dr Bareja.

Based on the encouraging results of the phase-2a study, Vicus will carry out the phase-2b study process very shortly.

Headquartered in Morristown, New Jersey, Vicus has leveraged its proprietary science to design and screen two-drug combinations which work together to reverse the body's maladaptive responses to cancer and its treatment. Its drug development programmes are supported by a network of leading clinical investigators in the United States, India and Japan.

The company's interests specifically lie in linking cancer, therapy, inflammation and supportive care indications such as cachexia, oral mucositis and fatigue. In many cases, these severe cancer-related disorders are caused by chemotherapeutic agents and radiation therapy which become key treatment-limiting factors and impair the effectiveness of curative therapy.

Vicus is in India to provide affordable, safe and effective medication to the cancer patients who face a challenge when it comes to expensive drugs. The company is also looking to partner with promising pharma companies in India to compliment and supplement the existing basket of products in the oncology segment. Many Indian pharma companies have expressed interest to team up with the company to take the drugs forward, stated Dr Bareja.

To further accelerate development and reduce costs, Vicus will also subsequently conduct the phase-3 trials in both the US and India under a commercial US IND regulatory framework.

The company is now aggressively looking at bringing into the market a combination drug as soon as a possible in the cancer space. Efforts are also on to address the therapy needs for other disease segments like HIV, Leishman's disease (Kalazar) and diabetes using the same scientific model adopted in its cancer research study.