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Rejuvenon's RC-8800 for Prostate Cancer Enters Human Testing; RC-1291 Ghrelin Mimetic Starts Phase II in Cachexia

Posted on: Wednesday, 20 July 2005, 12:00 CDT

In the contact information, the correct phone number for Gary C. Cupit of Rejuvenon Corporation should read: 908-203-6545 (sted 973-978-2546).

The corrected release reads:

REJUVENON'S RC-8800 FOR PROSTATE CANCER ENTERS HUMAN TESTING

RC-1291 Ghrelin Mimetic Starts Phase II in Cachexia Rejuvenon Corporation, a privately held pharmaceutical company developing therapeutics for cancer and metabolic disorders, has initiated a Phase I study of its second investigational drug, RC-8800, a small molecule that acts on the vitamin D (calcitriol) metabolic pathway, which is being developed as a treatment for prostate and other cancers. Rejuvenon has also advanced its other investigational drug candidate, RC-1291, into Phase II studies in cancer patients with cachexia (wasting), a common, life-threatening complication of malignant disease.

"Prostate cancer is the second leading cause of cancer death in American men," said Gary C. Cupit, PharmD, president and chief executive officer of Rejuvenon. "The American Cancer Society estimates that there at least 232,000 cases of prostate cancer reported in 2005 and more than 30,000 deaths. The market for prostate cancer treatments today is greater than US$1 billion, and expected to increase with the aging of the population."

The Phase I program will assess the safety and tolerability of RC-8800 in healthy subjects. Subsequent studies will be conducted in cancer patients. RC-8800 is a novel, highly selective and potent inhibitor of 24-hydroxylase (the enzyme responsible for the metabolism of calcitriol) that has several potential applications in oncologic and metabolic disease. Preclinical investigations of the use of RC-8800 in the treatment of other cancer types will be assessed in parallel with the Phase I study.

"We selected prostate cancer as our lead indication for RC-8800 because there remains a significant medical need for effective treatments against androgen-independent disease," said William J. Polvino, MD, Rejuvenon's senior vice president of development. "Published preclinical and clinical data support the hypothesis that augmenting vitamin D levels has beneficial effects for the treatment of prostate cancer. RC-8800 has demonstrated an enhancement of the antiproliferative activity in vitro of calcitriol against human tumor cell lines. We believe that these results will translate to an effective agent against prostate cancer and other cancers."

Calcitriol and RC-8800

In addition to its familiar activity on mineral metabolism in blood and bone, vitamin D has been implicated as an effective antiproliferative agent in several diseases. Specifically, research has shown that calcitriol can stimulate apoptosis (programmed cell death) in human prostate cancer cell lines and may have additional mechanisms of cancer inhibition. However, in its vitamin D3 form, calcitriol produces unacceptably high levels of calcium in the blood, a condition known as hypercalcemia, which can be a life-threatening complication in cancer patients. Therefore, pharmaceutical researchers are seeking drugs with better therapeutic windows that interact with the calcitriol pathways.

RC-1291 Phase II

Rejuvenon has also advanced its first investigational drug candidate, RC-1291, into Phase II studies in cancer patients with anorexia (loss of appetite) and cachexia (loss of body weight) syndrome, a common, life-threatening complication of underlying malignant disease. In January 2005, RC-1291 received US Food and Drug Administration (FDA) "fast track" designation for the treatment of cachexia and anorexia in cancer patients. Phase I studies have confirmed acceptable safety in healthy volunteers and showed dose-related increases in appetite and food intake, as well as in anabolic hormone levels.

Dr. Cupit said, "Both programs exemplify the advantages of Rejuvenon's big pharma-to-start-up licensing strategy. We advanced RC-1291 rapidly through Phase I and into Phase II. Likewise, RC-8800 has moved quickly through preclinical studies. We can begin Phase I studies while continuing preclinical work to guide future directions in clinical programs. With both of these programs in the clinic, we continue to expand our development team and leverage their skills through additional product acquisitions."

About Rejuvenon

Rejuvenon is a private pharmaceutical company whose strategy is to in-license and develop promising drug candidates that are ready for preclinical or clinical testing. The company is developing small molecule drugs to treat metabolic and oncologic diseases for which existing therapies are limited or marginally effective. Rejuvenon's first investigational drug candidates were in-licensed as preclinical compounds from Novo Nordisk in May 2001. RC-1291 is the furthest advanced of this series of orally and parenterally deliverable small molecules with therapeutic potential in cancer and metabolic diseases. The company is moving several additional molecules through preclinical development while actively seeking other preclinical in-licensing candidates to fill the development pipeline.

Source: Business Wire

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