BERKELEY HEIGHTS, NJ, April 26, 2001
- Genta Incorporated (Nasdaq: GNTA) reported that Dr. Robert E.
Klem, Vice-President and Chief Technical Officer, delivered the
keynote address today at the TIDES Oligonucleotide and Peptide
Technology Conference this morning in Tucson, AZ. In his
presentation, Dr. Klem updated preclinical, clinical, and
manufacturing issues regarding Gentas second and third generation
oligonucleotide research programs, which encompass drugs that use
both antisense and "decoy" mechanisms.
Regarding the clinical program for Genasense
TM
, Gentas lead antisense drug, Dr. Klem noted: "Patient accrual to
our lead studies is strong, which reflects both high investigator
enthusiasm and strong interest by the medical community. We
continue to anticipate completing enrollment in the melanoma study
later this year. Although I perceive that external interest has
mostly focused on our melanoma trial, in fact our other lead
programs may also conclude on roughly the same timeline. Thus, at
this point, I believe our first NDA for Genasense
TM
" which remains on track for filing during the first half of
2002 - could be submitted from any one of our "registration
quality" programs."
Regarding manufacturing issues, Dr. Klem observed: "In our
clinical development program and looking forward to next years
anticipated launch of Genasense
TM
, Genta is strongly advantaged by our strategic partnership with
the Life Sciences group at Avecia Ltd., the worlds largest
manufacturer of such compounds. Manufacturing quality has been a
key issue for FDA, and as the company with the first antisense
product intended for systemic use, Genta has anticipated a high
level of regulatory scrutiny. We are very pleased with the Avecia
collaboration, and both parties remain committed to establishing
the highest quality standards in our manufacturing processes of
this product."
