Nandi...
Did some poking around looking for GH studies. Here's one that your probably already familiar with. Granted...it's from the pharm company that makes the drug, so there could be an obvious conflict of interest. This is sort of like asking exxon who makes the best gas. Anyway, here it is.
SERONO ANNOUNCES SIGNIFICANT RESULTS FROM TWO CLINICAL TRIALS OF SEROSTIM® AT THE XIV INTERNATIONAL AIDS CONFERENCE
Rockland, MA and Geneva, Switzerland, July 9th 2002 - Serono S.A. (virt-x: SEO and NYSE: SRA) announced positive results of two major clinical trials of Serostim® [somatropin (rDNA origin) for injection] for the treatment of AIDS-related metabolic complications at the XIV International AIDS Conference in Barcelona, Spain. Results of both trials will be presented as late breaker sessions on Thursday, July 11th and Friday, July 12th during the International AIDS Conference.
"The positive findings from the Serostim® trials provide excellent news for the HIV community and for people living with AIDS," said Stevo Knezevic, Senior Executive Vice President, Clinical Development. "The findings of these two trials enhance our understanding of HIV-related metabolic complications and will help us develop improved therapies."
The Serostim® for the Treatment of Adipose Redistribution Syndrome study, a Phase II/III, double-blind, placebo-controlled study, designed to evaluate Serostim® as a potential therapy for HIV-Associated Adipose Redistribution Syndrome (HARS), demonstrated positive results in reducing adipose tissue maldistribution. HARS, a subset of a condition called HIV-related lipodystrophy syndrome, consists of abnormal fat distribution and altered metabolism. Serono is working with the US Food and Drug Administration (FDA) to finalize plans for the continued development of this program. Serostim® is currently not approved for the treatment of HARS.
The Serostim® AIDS wasting study, a Phase IV, confirmatory, randomized, double-blind, dose-ranging study, confirmed the clinical efficacy of Serostim® in the treatment of AIDS wasting by achieving its primary and secondary endpoints. Following discussions with the FDA, data from this trial will be submitted to the agency.
Serostim® for the Treatment of Adipose Redistribution Syndrome (STARS) Study
"The results of the STARS study indicate that Serostim® has a potential role in the treatment of body composition issues associated with lipodystrophy, which is an important finding for a condition that has a significant impact on HIV positive patients in the US who experience some form of fat maldistribution or lipodystrophy," said lead investigator, Donald Kotler, M.D., St. Luke's Roosevelt Hospital, New York. "The STARS trial is a critical step to learning more about the condition and potential therapies."
The STARS trial involved 239 patients at trial sites located throughout the US. The primary objective of the STARS study was to determine whether Serostim® treatment reduces adipose tissue maldistribution more effectively than placebo. The co-primary endpoints were a reduction in visceral adipose tissue (VAT) as assessed by CT1 scan and the ratio of trunk to limb fat as assessed by DXA2 technology. Secondary endpoints included Serostim's® effect on lean body mass and quality of life/body image self assessment. Patients were randomized into three treatment groups, which included Serostim® 4 mg daily, Serostim® 4 mg on alternate days and placebo.
The first co-primary endpoint shows that the decrease in VAT from baseline to week 12 was highly significant in the Serostim® 4 mg daily group (p<0.001) as compared to placebo. The mean reduction in the area of VAT across the mid-abdomen in males receiving Serostim® 4mg daily was 31.0cm2 (9.2% of the baseline mean value) and 34.2cm2 (13.5% of the baseline mean value) for females. The second co-primary endpoint demonstrates that the trunk to limb fat ratio was significantly reduced in both the Serostim® 4 mg daily (p<0.001) and Serostim® 4 mg on alternate day (p<0.001) groups compared to the placebo group.
The results of the secondary endpoints were also positive. Compared to the placebo group, results indicate a significant change in lean body mass from baseline to week 12 for those receiving Serostim® 4 mg daily (p<0.001) and 4 mg on alternate days (p<0.001) groups, with the mean increase ranging from 3.0 kg in women and 3.5 kg in men, and 2.1 kg in women and 2.8 kg in men, respectively. Serum total cholesterol declined by 12.5 mg/dl in the Serostim® 4 mg daily group and by 7.5 mg/dl in the Serostim® 4 mg on alternate days group. Both of these declines were significantly greater than the change seen in the placebo group. In addition, the change from baseline Quality of Life summary score was more favorable on Serostim® 4 mg daily (p<0.01) and on Serostim® 4 mg on alternate days (p<0.05) as compared to placebo. Adverse reactions reported during this clinical trial were consistent with those expected within the current approved indication for Serostim®.
Serostim® AIDS Wasting Confirmatory Trial
"This study confirmed that Serostim®, in a dose dependent manner, was able to restore lean body mass to patients with AIDS wasting," said trial investigator, Graeme Moyle, MD, Chelsea and Westminster Hospital, London, UK. "This restoration was accompanied by direct clinical benefits, such as improved physical performance and Quality of Life."
The Serostim® AIDS wasting confirmatory trial included more than 700 patients at US, EU and other international trial sites. Following the accelerated approval of Serostim® by the FDA, Serono conducted a Phase IV study to confirm the safety and efficacy of Serostim®. Trial enrollees were randomized into three treatment groups to receive Serostim® 6 mg daily, Serostim® 6 mg on alternate days or placebo for a 12-week treatment period.
The primary endpoint of the study was to confirm the clinical efficacy of Serostim® compared with placebo, based on exercise function change as assessed by cycle ergometer work output from baseline to week 12. The results of the primary endpoint were positive and demonstrated a highly significant increase of work output of 9.9% in the group treated with Serostim® 6 mg daily and a decrease of 1% in the placebo group (p<0.0001).
1.CT scan is an x-ray based, non-invasive diagnostic test.
2.Dual-Energy X-Ray Absorptiometry (DXA) is an x-ray based, non-invasive diagnostic test.
The secondary endpoint was the change in lean body mass as measured by bioimpedance spectroscopy (BIS) from baseline to week 12. Findings demonstrate a dose-response relationship. The quantity of lean tissue gained in the group treated with Serostim® 6mg daily (median gain in lean body mass 5.2 kg) and in the group treated with Serostim® 6 mg on alternate days (median gain in lean body mass 3.3 kg) was significantly greater compared to the placebo group (median gain in lean body mass 0.6 kg) (p<0.0001 for both Serostim® doses). Furthermore, patients receiving Serostim® 6 mg daily had a significantly greater effect in terms of median gain in lean body mass than those patients receiving Serostim®
6 mg on alternate days (p=0.017). Adverse reactions reported during this clinical trial were consistent with those expected within the current approved indication for Serostim®.
The study used two Quality of Life scales to assess patients' response to treatment with Serostim® for AIDS wasting. Results were generally favorable. When asked the question 'Do you think this treatment has been of benefit to you?,' Serostim® treated patients responded significantly more favorably than those treated with placebo (p<0.0001). In addition, patients receiving Serostim® 6 mg daily responded significantly more favorably than those treated with Serostim® 6 mg every other day (p=0.004).