bob the builder
Dutch Bodybuilder
- Lid sinds
- 7 aug 2006
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- 347
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ik heb hier een aantal jaar geleden ook al eens iets over gelezen...?
en nu ook weer op ergogenics
weet iemand hier meer over?
is het op de markt enz..
Rejuvenon’s RC-1291 Ghrelin Mimetic Receives Fast Track Designation from FDA for Cancer Anorexia/Cachexia
BRIDGEWATER, NJ (January 10, 2005): Rejuvenon Corporation, a privately held pharmaceutical company developing therapeutics for cancer and metabolic disorders, has received US Food and Drug Administration (FDA) “fast track” designation for its investigational compound, RC-1291, a small-molecule ghrelin mimetic, for the treatment of cachexia (loss of body weight) and anorexia (loss of appetite) in cancer patients. The anorexia/cachexia syndrome is a common, life-threatening complication of underlying malignancies.
“There is a significant unmet need for a pharmaceutical treatment in cancer cachexia.” said Gary C. Cupit, PharmD, president and chief executive officer of Rejuvenon. “Unexpected weight loss is an all-too-common and devastating consequence of cancer. Currently, effective treatments are lacking and the patient population in need of an effective treatment is substantial. Clinicians and patients are seeking a product that offers the potential we see in Rejuvenon’s lead candidate, RC-1291.”
The fast-track programs of the FDA are designed to facilitate the development and expedite the review of new drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. In its letter to Rejuvenon, the FDA stated that based on preclinical and early clinical data, RC-1291 shows potential as a treatment for cancer anorexia/cachexia. This syndrome frequently accompanies malignant disease states and often results in the death of the patient. In these patients, weight loss is an independent risk factor for poor survival, and cachectic patients also suffer increased complications from surgery, radiotherapy, and chemotherapy. To date, there are no effective treatments approved for this indication.
“Preclinical and clinical data have demonstrated the potent appetite-stimulating effects of RC-1291,” said William J. Polvino, MD, Rejuvenon’s senior vice president of development. “In addition, RC-1291 has potential anabolic attributes that we expect to reduce or eliminate the ongoing loss of body weight and/or muscle mass. No other agent provides the dual actions of potent appetite stimulation and anabolic activity. Consequently RC-1291 represents an important therapeutic prospect in the treatment of cancer anorexia/cachexia. We expect intervention with RC-1291 to improve appetite and food intake and attenuate or reverse ongoing weight loss. Additional benefits may include improvements in quality of life and functional performance.”
About Ghrelin and RC-1291 The recent discovery of ghrelin-mediated effects on appetite opens a new avenue for pharmaceutical treatment. Ghrelin is a small endogenous protein that acts on the Growth Hormone Secretagogue Receptor (GHSR), a G-Protein Coupled Receptor recognized as a key control point in the growth hormone signaling pathway. The GHSR is a target for treatment of several metabolic disorders including those related to maintenance of ideal body weight and composition. Agonists for this receptor have been identified as drug candidates for treatment of wasting and body fat redistribution syndromes associated with a range of diseases, such as cancer and AIDS. However, potential clinical use of ghrelin itself for wasting disorders is limited, because it must be administered by injection.
RC-1291 is a synthetic, small-molecule ghrelin mimetic that binds to, and stimulates, the GHSR. Unlike ghrelin, RC-1291 can be delivered by mouth. This highly potent, orally available compound is intended to be administered as a convenient once-daily treatment for patients with cancer anorexia/cachexia. The compound has been studied in a series of seven completed or ongoing clinical studies in human volunteers, including a double-blind placebo-controlled study in which, compared to placebo, RC-1291 significantly increased appetite and spontaneous food intake. Under the FDA fast-track designation, Rejuvenon plans to conduct Phase II trials later this year.
o ja nog een link voor als je naar de states gaat op vakantie ofzo en je wil jezelf wel als proefkonijn opgeven....
Clinical Trial: Placebo Controlled, Randomized Safety and Efficacy Study of RC-1291 in Cancer Anorexia/Cachexia.
en nu ook weer op ergogenics
weet iemand hier meer over?
is het op de markt enz..
Rejuvenon’s RC-1291 Ghrelin Mimetic Receives Fast Track Designation from FDA for Cancer Anorexia/Cachexia
BRIDGEWATER, NJ (January 10, 2005): Rejuvenon Corporation, a privately held pharmaceutical company developing therapeutics for cancer and metabolic disorders, has received US Food and Drug Administration (FDA) “fast track” designation for its investigational compound, RC-1291, a small-molecule ghrelin mimetic, for the treatment of cachexia (loss of body weight) and anorexia (loss of appetite) in cancer patients. The anorexia/cachexia syndrome is a common, life-threatening complication of underlying malignancies.
“There is a significant unmet need for a pharmaceutical treatment in cancer cachexia.” said Gary C. Cupit, PharmD, president and chief executive officer of Rejuvenon. “Unexpected weight loss is an all-too-common and devastating consequence of cancer. Currently, effective treatments are lacking and the patient population in need of an effective treatment is substantial. Clinicians and patients are seeking a product that offers the potential we see in Rejuvenon’s lead candidate, RC-1291.”
The fast-track programs of the FDA are designed to facilitate the development and expedite the review of new drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. In its letter to Rejuvenon, the FDA stated that based on preclinical and early clinical data, RC-1291 shows potential as a treatment for cancer anorexia/cachexia. This syndrome frequently accompanies malignant disease states and often results in the death of the patient. In these patients, weight loss is an independent risk factor for poor survival, and cachectic patients also suffer increased complications from surgery, radiotherapy, and chemotherapy. To date, there are no effective treatments approved for this indication.
“Preclinical and clinical data have demonstrated the potent appetite-stimulating effects of RC-1291,” said William J. Polvino, MD, Rejuvenon’s senior vice president of development. “In addition, RC-1291 has potential anabolic attributes that we expect to reduce or eliminate the ongoing loss of body weight and/or muscle mass. No other agent provides the dual actions of potent appetite stimulation and anabolic activity. Consequently RC-1291 represents an important therapeutic prospect in the treatment of cancer anorexia/cachexia. We expect intervention with RC-1291 to improve appetite and food intake and attenuate or reverse ongoing weight loss. Additional benefits may include improvements in quality of life and functional performance.”
About Ghrelin and RC-1291 The recent discovery of ghrelin-mediated effects on appetite opens a new avenue for pharmaceutical treatment. Ghrelin is a small endogenous protein that acts on the Growth Hormone Secretagogue Receptor (GHSR), a G-Protein Coupled Receptor recognized as a key control point in the growth hormone signaling pathway. The GHSR is a target for treatment of several metabolic disorders including those related to maintenance of ideal body weight and composition. Agonists for this receptor have been identified as drug candidates for treatment of wasting and body fat redistribution syndromes associated with a range of diseases, such as cancer and AIDS. However, potential clinical use of ghrelin itself for wasting disorders is limited, because it must be administered by injection.
RC-1291 is a synthetic, small-molecule ghrelin mimetic that binds to, and stimulates, the GHSR. Unlike ghrelin, RC-1291 can be delivered by mouth. This highly potent, orally available compound is intended to be administered as a convenient once-daily treatment for patients with cancer anorexia/cachexia. The compound has been studied in a series of seven completed or ongoing clinical studies in human volunteers, including a double-blind placebo-controlled study in which, compared to placebo, RC-1291 significantly increased appetite and spontaneous food intake. Under the FDA fast-track designation, Rejuvenon plans to conduct Phase II trials later this year.
o ja nog een link voor als je naar de states gaat op vakantie ofzo en je wil jezelf wel als proefkonijn opgeven....
Clinical Trial: Placebo Controlled, Randomized Safety and Efficacy Study of RC-1291 in Cancer Anorexia/Cachexia.
