STRASBOURG, France, November 13 /PRNewswire-FirstCall/ -- Transgene S.A. announces today updated data of the completed Phase II trial and development plans going forward for TG 4001, Transgene’s therapeutic HPV vaccine for treating precancerous lesions of the cervix (high grade cervical intraepithelial neoplasia - CIN 2/3).
In April 2006, Transgene released positive Phase II results evidencing the effectiveness of TG 4001 in patients with CIN 2/3. Evaluation was performed at month 6 following the first vaccine injection. The complete 6-month results, which confirm product efficacy, are now available on all 21 recruited patients:
- 10 women had no more CIN2/3; and
- none of these 10 women had any HPV16 E6 / E7 mRNA detected; and
- no serious side effects were observed.
A further assessment was performed at month 12 for the patients not having undergone surgical excision of the CIN lesions at month 6. None of the six patients who have reached the month 12 evaluation showed any CIN2/3 relapse or any HPV16 persistence or re-infection, evidencing sustainability of the response induced by the vaccine.
To Transgene’s knowledge, these results constitute a first in the field of therapeutic vaccination to treat chronic viral infections and in the case of CIN 2/3, create the possibility for a safe, non-invasive alternative to surgery.
Transgene is currently preparing to initiate, in the fourth quarter of 2007, a placebo-controlled Phase III trial programme enrolling an estimated 500 patients in Europe and the U.S. The programme is designed to evaluate TG 4001 in women with CIN2/3 caused by HPV16. The primary endpoint of the trials will be the resolution of the CIN2/3 lesion twelve months after vaccination. These development plans are being discussed with regulatory authorities and are expected to be formally approved by the EMEA and the FDA during the first quarter of 2007.
In October 2006, Transgene was granted US patent 7,118,754 “Pharmaceutical composition for treating papillomavirus tumors and infection”, covering its HPV therapeutic vaccine TG 4001, and related methods for the treatment of papillomavirus infection, dysplasia or cancer of the cervix.
“With the preparation of Phase III trials with TG 4001, Transgene is making a significant step forward in advancing its product portfolio closer to market ", said Philippe Archinard, Chief Executive Officer of Transgene. “With the recent U.S. patent grant, TG 4001 intellectual property is further strengthened. Transgene’s partnering discussions for TG 4001 are ongoing and our current clinical development plans are being shared with the potential partners.”
About cervical HPV-related diseases and treatments:
Human Papilloma Virus infection has been recognized as the necessary cause of precancerous cervical lesions and cervical cancers.
HPV infection is the most common sexually transmitted disease affecting about 400 million women worldwide. Most infections are spontaneously eliminated in less than one year. In the remaining cases, persistent high-risk HPV infection can lead, after several years or decades, to precancerous lesions - called cervical intraepithelial neoplasia of grades 2 and 3 (CIN 2/3) - and then to cervical cancer.
HPV-linked disease incidence (number of new cases per year): Europe / U.S.A. World % linked to HPV16 Cervical cancer 80,000 500,000 approximately 50 % High grade 900,000 1,400,000 approximately 50 % pre-cancerous lesions (CIN 2/3)
Due to the wider use of HPV testing, high-risk HPV infection is being diagnosed in an increasing number of women, but no anti-viral treatment is currently available and surgical resection is the only therapeutic solution. Although highly effective, lesion resection presents medical complications such as hemorrhaging in 3.5 % - 5 % of cases (International Agency for Research on Cancer), a risk of obstetrical complications and an HPV16 CIN2/3 recurrence rate of about 37% after two years.
The HPV16, 18, 31 and 33 genotypes have the highest risk of transforming infected cells into cancerous cells. HPV type 16 alone is responsible for about half of all CIN 2/3.
About TG 4001 (MVA-HPV-IL2):
Transgene’s TG 4001 product candidate is based on the MVA virus carrying and expressing HPV16 E6 and E7 genes. The MVA vector is a highly attenuated strain of vaccinia virus that combines an extensive history of safety with the ability to stimulate a strong immune response to antigens.
The TG 4001 therapeutic vaccine is designed to induce:
- a specific immunity: E6 and E7 antigens presentation to T cells through the MHC molecules (class I and II) to induce specific cellular and humoral immune responses; and
- a non-specific activation of the immune system via the vaccinia virus and the interleukin 2 (IL2) adjuvant of the immune response.
Transgene also believes that TG 4001 could have further applications beyond CIN 2/3 as a single agent in low grade CIN (CIN1) or cervical cancers in combination with existing treatments.
About Transgene:
Transgene is a France-based biopharmaceutical company dedicated to the development of therapeutic vaccines and immunotherapeutic products in oncology and infectious diseases. The company has three compounds in Phase II trials and one compound in Phase I studies. Transgene has bio-manufacturing production capacities for viral-based vectors and technologies available for out-licensing. For further information about Transgene, please visit www.transgene.fr
Cautionary note regarding forward-looking statements:
This press release contains forward-looking statements referring to the clinical testing, approval and partnership discussions for one of Transgene’s therapeutic product candidates. However, clinical testing and product development depend on a variety of factors, including the timing and success of patient enrolment, the requirement for approvals by health authorities for further product testing and the risk of unanticipated adverse patient reactions. Results from future studies with more data may show less favourable outcomes than prior studies, and there is no certainty that product candidates will ever demonstrate adequate therapeutic efficacy or achieve regulatory approval.
The successful commercialization of a product also requires adequate financial and marketing support and acceptance by the medical community, none of which can be assured at this time. Transgene’s discussions with potential partners may not result in a satisfactory partnership agreement. Finally, Transgene’s currently available financial resources do not ensure its continued activity beyond the end of 2007, and thus additional financing would be required to complete the product testing and development described above. For further information on the risks and uncertainties involved in the testing and development of Transgene’s product candidates, see Transgene’s Document de reference on file with the French Autorite des Marches Financiers and available on its website at http://www.amf-france.org and Transgene’s website http://www.transgene.fr.
Press Contacts: Transgene Philippe Poncet +33-3-88-27-91-21 Capital MS&L Shaun Brown Mary Clark +44-(0)20-7307-5330 Image 7 Estelle Guillot-Tantay Tiphaine Hecketsweiler +33-1-53-70-74-93
Transgene S.A.
CONTACT: Press Contacts: Transgene, Philippe Poncet, +33-3-88-27-91-21;Capital MS&L, Shaun Brown, Mary Clark, +44-(0)20-7307-5330; Image 7,Estelle Guillot-Tantay, Tiphaine Hecketsweiler, +33-1-53-70-74-93
