Crunch time for Helsinn's cancer support therapy
This is a big week for Swiss pharma company Helsinn as it gets ready to present pivotal data on anamorelin, its lead pipeline candidate, at the European Society for Medical Oncology (ESMO) conference in Madrid.
Anamorelin does not treat tumours directly but is designed to tackle a serious complication of cancer - known as cancer anorexia-cachexia (CACS) - which can take a massive toll on the wellbeing of patients and has few treatment options.
CACS is defined by an ongoing loss of body weight and lean muscle mass that cannot be fully reversed by conventional nutritional support and leads to progressive functional impairment that make the side effects of chemotherapy worse and interferes with the effectiveness of therapy, according to Helsinn.
The condition affects patients with some forms of cancer more than others, and Helsinn has tested anamorelin in patients with non-small cell lung cancer (NSCLC), who seem particularly prone to the muscle-wasting syndrome.
Helsinn's drug is a first-in-class, orally-active agonist for the ghrelin (or 'hunger hormone') receptor, which signals hunger to the brain but also has a range of other effects on energy balance in the body.
Assuming the two phase III trials due to be reported at ESMO this week are positive, Helsinn could be on track for a launch of what might become its biggest-ever product some time in 2015 or 2016, according to analysts.
There has been some debate in the past over whether CACS was actually a distinct clinical disorder at all, although a study published in 2010 in the journal Supportive Care in Cancer (SCC) across multiple advanced cancer types found a characteristic set of symptoms for the syndrome which, when present, adversely affected survival.
Now CACS is more generally accepted as a real phenomenon, and is typically treated using Bristol-Myers Squibb's appetite stimulant Megace (megestol acetate) or, in some cases, medical marijuana, although neither of these approaches is associated with much clinical success.
Helsinn has been building a portfolio of supportive care products for cancer patients, and already sells Aloxi (palonosetron) for chemotherapy-induced nausea and vomiting (CINV) and Gelclair, a protective gel to treat mouth ulcers (mucositis) caused by cancer treatment.
The company has been busily building up a network in anticipation of approval for anamorelin, which it sees as the most promising candidate in its pipeline.
Licensing deals for the CACS therapy have already been signed with Chugai - also a partner for Aloxi in some markets and an already-filed combination follow-up based on palonosteron and netupitant - as well as other regional players such as Italy's Angelini, Turkey's Gen Ilac and Mundipharma in China.
"Helsinn believes anamorelin may offer the potential for a new approach to treating the symptoms of this multifactorial clinical condition," said the company's chief executive Riccardo Braglia.
"CACS is a debilitating condition which is distressing for patients and caregivers for whom getting the most out of every day is crucial," he added.
Helsinn is not, however, on its own in developing a therapy for muscle wasting in cancer. Rival company GTx is currently deciding whether to press ahead with a filing in Europe for its oral selective androgen receptor modulator enobosarm in advanced NSCLC patients, based on the results of the POWER 1 and 2 pivotal studies which were presented at this year's American Society of Clinical Oncology (ASCO) meeting.
Meanwhile, Ohr Pharmaceutical completed a phase II trial last year of its immunomodulatory candidate OHR/AVR118 in advanced cancer patients with positive results. The drug is thought to exert its effects by affecting the action of cytokines in the body.
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