PARIS - Transghne SA decided at the last minute to pull its proposed offering of 1.2 million shares on France's Nouveau Marchi, following the news that there was a delay and the closing was expected on Friday.
The company also released positive results from a Phase I gene therapy trial showing the delivery of interleukin-2 was well tolerated and produced no side effects.
Although the financing operation remained "dependent on market conditions," the Strasbourg-based gene therapy company, which also is quoted on Nasdaq, had seemed unperturbed by the downturn in biotechnology share prices on the Nouveau Marchi in the second half of March. By the time it decided to pull the plug, the shares had regained a significant part of that lost ground.
Under the terms of the share issue proposal approved by the French stock market watchdog, the Commission des Opirations de Bourse, Transghne has until May 2002 to put it into effect. (See BioWorld International, March 29, 2000, p. 6.)
The Phase I trial of a gene therapy for cancer involved the use of an intratumoral delivery system administering the cytokine IL-2 by means of an adenoviral vector. Bernard Escudier, who is in charge of the trial at the Institut Gustave Roussy cancer clinic in Villejuif, said it appeared safe and well tolerated. The vector was developed by Transghne and is being tested in patients with advanced lung cancer.
Transghne pointed out that IL-2 already is authorized for the treatment of melanomas and metastatic kidney cancer, but its use in patients with advanced tumors is restricted because of the high degree of toxicity associated with the systemic administration of this protein. Preclinical animal studies demonstrated that delivering IL-2 directly to the tumor using an adenoviral vector brought greater efficacy and reduced toxicity.
Those findings already were confirmed in a Phase I trial in France on patients suffering from gastrointestinal cancer. These latest results bring added confirmation and show in particular that there was prolonged expression of the IL-2 gene in the patients treated, and that there were no major side effects whatever the dose administered. Transghne recently was granted a U.S. patent covering the technology it has developed for producing adenoviral vectors for gene therapy. (See BioWorld International, April 5, 2000, p. 5).
The company also is preparing to embark on the first Phase I trial of a gene therapy for Duchenne's disease, a form of muscular dystrophy. Transghne is developing gene therapies for this and a similar pathology - Becker's dystrophy - within the framework of a cooperation agreement it signed with the French Muscular Dystrophy Association (AFM) in November 1998. Under that agreement, which renewed an earlier three-year convention and runs to June 30, 2001, the AFM is providing Transghne with research funding of FFr84 million (US$14.7 million).
The therapy entails injecting patients with part of a normal dystrophin gene, a protein that is completely or partially lacking in patients suffering from Duchenne's disease or Becker's dystrophy. The Phase I trial is due to start during the second quarter of this year at the Institute of Myology, which is located in the La Pitii-Salpitrihre hospital in Paris and is jointly financed by the AFM and the Paris public hospital authority. The trial will be conducted on nine individuals aged 15 or older, who have measurable muscular force and no immune deficiency. It will be targeted specifically at maintaining or enhancing the grip between the thumb and forefinger, and also will evaluate patients' immune response.