By Brady Huggett
Not seeing the results it wanted, Praecis Pharmaceuticals Inc. said it will no longer back the development of Latranal for musculoskeletal pain, leaving it with just Plenaxis and Apan to concentrate on.
Malcolm Gefter, CEO, president and chairman of Praecis, called the in-licensing of Latranal from Pharmaceutical Applications Associates, of Seattle, ¿an opportunistic situation,¿ and said the trial was conducted ¿relatively quickly and at a relatively low expense.¿
¿The [Latranal] program was licensed in from another small company and we performed the very first clinical trial to see if the product had any utility,¿ Gefter said. ¿The reason we did it was because it was topical and we thought [the trial] would be quick enough to slot in between [Plenaxis and Apan.]¿
While the next step for the product isn¿t entirely clear, Gefter said one thing was certain.
¿It isn¿t that we don¿t know what we will do with it ¿ it is we know what we won¿t do with it,¿ he said. ¿We do not intend to develop it any further at this time.¿
Praecis, of Waltham, Mass., also provided specifics on three studies under way with Plenaxis, for the treatment of prostate cancer. The drug was linked to Amgen Inc., of Thousand Oaks, Calif., in a joint development and commercialization pact. However, following word from the FDA that Praecis needed to address certain issues concerning its new drug application, Amgen abandoned the program. (See BioWorld Today, Sept. 13, 2001, and Sept. 20, 2001.)
The three programs, now being conducted by Praecis alone, explore how the product can benefit patients.
The first study is the least important clinically, but will provide data on the relationship between the drug and patients. It is a rollover study for the continued treatment of patients who participated in earlier prostate cancer trials and wished to remain on Plenaxis.
But there also is a Phase IIIb trial to evaluate prostate gland reduction. The trial compares the effects of neoadjuvant hormonal therapy with Plenaxis or Lupron Depot. Gefter explained that Plenaxis was shown in Phase II trials to reduce testosterone levels in patients without an initial surge of the hormone, thereby reducing tumor burden in patients with prostate cancer. With Lupron, however, tumor burden is increased, Gefter said, because of the early jump in testosterone. The idea is to determine if Plenaxis can reduce the size of tumors enough so they can be treated with radioactive seed implantation ¿ something that cannot be done on hefty tumors.
Plenaxis has shown the ability to suppress, over the long term, follicle-stimulating hormone (FSH), and the third trial investigates this theory.
¿FSH has been suggested by several publications as an independent growth factor of prostate cancer cells,¿ Gefter said. ¿The study in progression is to look at patients who have failed Lupron therapy, where those patients are then put on Plenaxis. We reconfirmed that Plenaxis has this independent activity that is separate to this testosterone activity.¿ Gefter added that Praecis expects to see results from this the trial ¿within a year.¿
Apan, Praecis¿ drug for Alzheimer¿s disease, is in a Phase I trial that is ¿on track,¿ Gefter said.
With Latranal gone now and Apan in early stage development, Plenaxis¿ flagship status is larger than ever.
¿We are moving ahead to study the patients sampled that we are obligated to study, and we are ready to go back to the FDA with the protocol for the use of Plenaxis in conjunction with alternative therapies like Lupron,¿ Gefter said. ¿If we found that patients were not being sufficiently treated with Plenaxis, could they be treated with an alternative therapy? We are now ready to discuss the next step in the approval process.¿
Praecis¿ stock (NASDAQ:PRCS) rose 14 cents Friday to close at $3.73.