Theratechnologies Inc. expects to initiate a Phase III trial later this year for ThGRF, a candidate for HIV-associated lipodystrophy.
At the same time, the Montreal-based company said it intends to restructure its senior management responsibilities and recruit a new chief executive officer. Luc Tanguay, the firm's current president and CEO, will assume the role of senior executive vice president and chief financial officer once a new CEO is named.
Meanwhile, subsidiary Celmed BioSciences Inc., also of Montreal, agreed to acquire NewBiotics Inc., of San Diego.
The new CEO will be charged with leading the company through development, possible partnerships and commercialization of ThGRF in one or more indications.
HIV-associated lipodystrophy was selected as the first indication for late-stage study because it is the most likely to be successful, Peter McBride, Theratechnologies' vice president, investor relations and public affairs, told BioWorld Today. He added that Theratechnologies believes ThGRF is a potential blockbuster.
ThGRF is a stabilized analogue of the growth hormone-releasing factor (GRF) that induces the production and secretion of growth hormone in a specific, controlled and pulsatile fashion. That property makes it a strong candidate as a treatment for many diseases related to aging and obesity, as those conditions are characterized by a significant reduction in growth hormone secretion, the company said.
The company had evaluated the candidate in muscle wasting related to hip fracture surgery, but dropped the plan when Phase II results came up negative. (See BioWorld Today, Dec. 10, 2003.)
All told, Theratechnologies studied ThGRF in more than 600 patients as part of a Phase II program meant to define the best use of the candidate. The top two choices were wasting associated with chronic obstructive pulmonary disease and HIV-associated lipodystrophy.
The studies demonstrated that ThGRF safely induced clinical benefits including an anabolic effect (increased muscle mass with trends for functional improvement), lipolytic effects (visceral fat reduction and improved lipid profile), stimulation of the immune system and enhanced cognitive function (daytime alertness), the company said.
Meanwhile, as part of its plan to restructure management and take ThGRF forward, Thierry Abribat, previously the firm's vice president and chief scientific officer, was named executive vice president, business development. Luc Vachon, previously the vice president, drug development, will add research activities in his new role as executive vice president, research and development. Krishna Peri, formerly director, discovery, will become vice president, research.
Theratechnologies also announced changes that will reduce the interrelationships between the boards of Theratechnologies and Celmed, following Celmed's acquisition of NewBiotics.
Tanguay resigned from Celmed's board while André de Villers is leaving Theratechnologies' board and relinquishing his current role as vice chairman. De Villers continues in his responsibilities as president and CEO of Celmed. In addition, Monique Lefebvre will leave the Theratechnologies board and will replace Tanguay on Celmed's board.
Celmed's acquisition of NewBiotics is expected to broaden its technology base, diversify its product pipeline in the oncology sector and add key shareholders from the U.S., Europe, Canada and Asia. Celmed's core technology is Theralux, a system consisting of a photosenitive drug and a device for eliminating unwanted cells, for treating disorders related to blood and bone marrow transplantation in oncology.
NewBiotics' most advanced product is NB1011, a compound in Phase I/II trials that exploits the enzyme thymidylate synthase. The company has other products at various stages of research, one of them based on an enzyme called estrone sulfatase, present at high levels in many cancers.
The acquisition is an all-share transaction under which NewBiotics' current shareholders will receive an ownership interest in Celmed of 29.7 percent. Consequently, Theratechnologies' ownership in Celmed will be reduced from 59.7 percent to 42 percent, and the Solidarity Fund QFL and SGF will each own 13.4 percent. The transaction is expected to close by the end of June.
Theratechnologies' stock (TSX:TH) Tuesday gained C25 cents to close at C$4.