Sapphire Therapeutics, Inc.'s Oral Ghrelin Mimetic Shows Potential for Treating Cancer Anorexia/Cachexia
Posted on: Thursday, 15 December 2005, 09:00 CST
Sapphire Therapeutics' novel oral ghrelin mimetic, RC-1291, has demonstrated potent dose-dependent appetite-stimulating effects in Phase I study data presented at the 3rd Rome Cachexia Conference, December 8-10. RC-1291 is currently undergoing Phase II studies in patients with cancer-related anorexia/cachexia syndrome, a common, life-threatening complication of underlying malignancies.
"The data we presented in Rome came from a body of studies that have already encouraged us to bring RC-1291 forward into Phase II," said Karen M. Kumor, MD, Sapphire's vice president of clinical research. "These studies confirm the drug's desired dual therapeutic actions of appetite stimulation and anabolic hormone release. The studies also provided safety and pharmacokinetic data in support of further development."
Sapphire researchers presented two posters at the Conference: "Biologic activity of RC-1291, a novel oral ghrelin mimetic for the treatment of cancer anorexia/cachexia: Results from a Phase I randomized, double-blind, placebo-controlled clinical trial in healthy volunteers" and "Pharmacokinetic (PK) profile of RC-1291, a novel oral ghrelin mimetic for the treatment of cancer anorexia/cachexia."
"The majority of cancer patients develop anorexia and cachexia, but despite the profound negative impact of the syndrome, including decreased survival, effective treatments are still lacking," said William J. Polvino, MD, executive vice president. "Clinicians and patients are seeking a product that treats cancer anorexia/cachexia, a significant unmet medical need. RC-1291 offers potential to address this need based on a growing body of data from the preclinical and early clinical studies, including those presented in Rome."
About Cancer Anorexia/Cachexia
Cachexia affects many patients with chronic diseases, including AIDS, cancer, organ failure, and rheumatoid arthritis. Sometimes called "wasting," symptoms include loss of lean body mass and appetite (anorexia). Cachexia frequently accompanies malignant cancers and is an independent risk factor for poor survival. To date, there are no approved treatments in the US for cancer anorexia/cachexia.
About Ghrelin and RC-1291
Ghrelin is a small endogenous protein that acts on the Growth Hormone Secretagogue Receptor (GHSR), recognized as a key control point in the growth hormone signaling pathway, and a target for treatment of several metabolic disorders, including those related to body weight and body composition. However, because it must be administered by injection, potential clinical use of ghrelin itself for wasting disorders is limited. GHSR agonists have been identified as drug candidates for treatment of wasting and body fat redistribution syndromes associated with diseases such as cancer and AIDS.
Sapphire is developing RC-1291, a synthetic, small-molecule ghrelin mimetic that can be administered orally, as a convenient once-daily treatment for patients with cancer anorexia/cachexia. RC-1291 received FDA fast-track designation in January 2005, and is currently undergoing Phase II trials in cancer patients with anorexia/cachexia.
About Sapphire Therapeutics
Sapphire is a private biopharmaceutical company that in-licenses and develops promising small-molecule drug candidates, to treat metabolic and oncologic diseases for which existing therapies are limited or marginally effective. The company's first investigational drug candidates are a series of orally active and parenterally deliverable small molecules with therapeutic potential in metabolic and oncologic diseases that were in-licensed as preclinical compounds from Novo Nordisk in May 2001. The furthest advanced of this series is RC-1291, currently in Phase II development. The second drug, RC-8800, is a small molecule that acts on the vitamin D (calcitriol) metabolic pathway, being developed as a treatment for various cancers, and is currently in Phase I development for prostate cancer. The company is advancing several additional molecules through preclinical development while actively seeking more drug candidates.
Source: Business Wire
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