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Ostarine is a member of a family of medicines called SARMs, or selective androgen receptor modulators, now in mid-stage trials to treat muscle loss related to cancer or to the normal process of aging.

It seems to increase lean mass and decrease insulin resistance

http://jcem.endojournals.org/cgi/content/full/84/10/3459

ReutersINTERVIEW-GTx says muscle drug holds promise09.02.08, 5:31 PM ET

United States - * CEO says muscle-wasting drug could become top product

* Says drug is years ahead of rivals in clinical trials

(Adds quotes, details and background on drugs, byline)

By Ransdell Pierson

NEW YORK (Reuters) - The chief executive of GTx Inc told Reuters Tuesday the company's experimental Ostarine medicine to build muscle mass in cancer patients and in the elderly has big sales potential and is several years ahead of rival treatments in clinical trials.

CEO Steiner said Ostarine has greater sales potential than GTx' best-known experimental drug, toremifene, now in late-stage studies, and intended to prevent prostate cancer and side effects caused by standard treatments for prostate cancer.

"I do believe the market ultimately is larger. It's a huge market," Steiner said in an interview, when asked if Ostarine -- being developed in partnership with Merck (nyse: MRK - news - people ) & Co Inc -- had bigger sales potential than its flagship toremifene product.

Steiner said GTx will likely seek U.S. marketing approval for toremifene in the fourth quarter, and that it has potential to garner eventual annual sales of up to $800 million.

"Prostate cancer is one cancer, whereas muscle wasting is a consequence of many cancers," Steiner said, explaining the likely greater potential for Ostarine over toremifene.

Ostarine is a member of a family of medicines called SARMs, or selective androgen receptor modulators, now in mid-stage trials to treat muscle loss related to cancer or to the normal process of aging.

Steiner said Ostarine was "years ahead" in studies versus similar medicines being developed by Pfizer Inc (nyse: PFE - news - people )Eli Lilly and Co (nyse: LLY - news - people )GlaxoKline (nyse: GSK - news - people ) Plc and other drugmakers.

If approved, Ostarine would likely have a big enough jump on rivals to ensure a commanding marketing advantage, he said. "Those that come later have to compare themselves to you."

Steiner said muscle wasting -- or loss of muscle mass -- is often a hallmark of cancer and a consequence of advancing age.

For the aging population, he said, Ostarine would be geared to patients who are losing their independence or likely to fall because of muscle wasting.

In company-sponsored trials, the drug has been shown to increase muscle mass by about three pounds in elderly men and postmenopausal women, when used for three months.

"That's what has gotten everybody excited about this compound," said Steiner, noting that GTx was also testing other SARMs in collaboration with Merck.

The stock closed up 95 cents, or 5.4 percent, to $18.66 on Nasdaq. Its 52-week range is $10.75 to $20. (Reporting by Ransdell Pierson; editing by Benkoe)Copyright 2008 Reuters

GTx Announces Ostarine Improved Insulin Resistance among Elderly,Patients in a Recently Completed Phase II Clinical Trial

MEMPHIS, Tenn.--(BUSINESS WIRE)--Apr 17, 2007 - GTx, Inc. (NASDAQ: GTXI) announced today that data from a recently conducted Phase II Ostarine clinical trial of 60 elderly men and 60 postmenopausal women revealed that insulin and glucose levels were reduced and insulin resistance was improved among subjects receiving the 3 mg dose ofostarine compared to baseline. These observations were even more pronounced among a subset of prediabetic subjects.

Data from the Phase II clinical trial of ostarine are being highlighted at the GTx Analyst Day meeting being held today from 11 a.m. to 2 p.m. at the Loews Regency Hotel in New York City. During the meeting, GTx also will provide information about its clinical development plans and commercialization strategy forostarine, the company's first-in-class selective androgen receptor modulator (SARM).

In the three month Phase II clinical trial in which patients with diabetes or obesity (BMI greater than 30) were excluded, subjects treated with ostarine 3 mg (n=23) had on average an 11% decline in fasting blood glucose (p less than 0.001), a 17.6% reduction in insulin levels (p=0.043), and a 26.8% reduction in insulin resistance (HOMA-IR) (p=0.037), when compared to their baseline measurements. Improvements in insulin resistance were more apparent among a small subset of prediabetic (fasting blood glucose of 100 - 125 mg/dL) patients (n=5) treated with ostarine 3 mg in whom the mean fasting blood glucose declined by 17.4%, insulin levels reduced by 29.4%, and insulin resistance decreased by 41.3%.

Improvements in insulin resistance among subjects receiving the 3 mg dose provide additional supporting evidence of the anabolic activity of ostarine. The resulting changes in body composition (increased muscle and decreased fat) with ostarinetreatment appear to have a beneficial impact on insulin resistance. These data compare favorably with results of clinical trials using FDA approved diabetic drugs in a prediabetic population. For example, in a one year study (the DREAM study), prediabetic patients taking rosiglitazone 8 mg evidenced a decline in fasting blood glucose of 9% from their baseline measurements (Lancet, 2006). Similarly, in prediabetic patients taking glipizide 2.5 mg for 6 months, the mean fasting blood glucose decreased by 4 percent, insulin declined by 17%, and insulin resistance reduced by 35% (son JG et al, 2006). In prediabetic patients taking metformin 1.7 g for 16 weeks, fasting blood glucose declined by 6%, insulin decreased by 29%, and the calculated insulin resistance decreased by approximately 39% (Bulcao C et al, 2007).

"The data from our Phase II clinical trial provide more evidence that ostarine is having the desired anabolic effect," said A. Morton, Jr, MD, Chief Medical Officer of GTx. "By increasing muscle and decreasing fat, ostarine appears to improve levels of glucose and insulin and to reduce insulin resistance. These data suggest ostarine may have a beneficial impact on prediabetic conditions and potentially diabetes, which, if validated in later studies, could provide the basis for our seeking expanded indications for ostarine."

"It would be clinically meaningful and exciting if ostarine is shown to have an effect of similar magnitude in chronic kidney disease patients where diabetes and prediabetes are highly prevalent," said T. Alp Ikizler, MD, Associate Professor of Medicine at Vanderbilt University School of Medicine.

GTx is planning to initiate a Phase IIb clinical trial evaluating ostarine for the treatment of chronic kidney disease muscle wasting by the end of the year 2007. Diabetes is a highly prevalent comorbidity among patients with chronic kidney disease. Nearly one half of treated Stage 3 and 4 chronic kidney disease patients are diabetic, and the majority of remaining patients are prediabetic. Testing ostarine in this population will allow, without limitation, the risks that (i) GTx will not be able to commercialize its product candidates if clinical trials do not demonstrate safety and efficacy in humans; (ii) GTx may not able to obtain required regulatory approvals to commercialize its product candidates; (iii) GTx's clinical trials may not be initiated and/or completed on schedule, or at all, or may otherwise be suspended or terminated; and (iv) GTx could utilize its available cash resources sooner than it currently expects and may be unable to raise capital when needed, which would force GTx to delay, reduce or eliminate its product development programs or commercialization efforts. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this press release. GTx's annual report on form 10-K filed with the U.S. Securities and Exchange Commission (the "SEC") on March 9, 2007, contains under the heading "Risk Factors," a more comprehensive description of these and other risks to which GTx is subject. GTx expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

Contact

GTx, Inc.Mc Stilwell, 901-523-9700Director, Corporate Communications & Financial Analysis

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