A Multicenter, Extension Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Two Doses of Linsitinib in Subjects with Active, Moderate to Severe Thyroid Eye Disease (TED) - VGN-TED-302

Start Date31 Oct 2023

Sponsor / Collaborator-

NCT06112340

/ RecruitingPhase 2/3

A Multicenter, Extension Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)

The overall study objective is to continue to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of linsitinib in subjects who were enrolled in the prior VGN-TED-301 through Week 24. These subjects include VGN-TED-301 Week 24 proptosis non-responders or subjects who relapse during the Follow-Up Period of VGN-TED-301.

Start Date11 Oct 2023

Sponsor / Collaborator

Sling Therapeutics, Inc.Startup

NCT05276063

/ Active, not recruitingPhase 2/3

A Phase 2b, Randomized, Double-Mask, Placebo-Controlled, Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)

The overall objective is to study the safety, pharmacokinetics and efficacy of linsitinib (a small molecule IGF-1R inhibitor) administered orally twice daily (BID) vs. placebo, at 24 weeks in the treatment of subjects with active, moderate to severe thyroid eye disease (TED).

Start Date01 Jul 2022

Sponsor / Collaborator

Sling Therapeutics, Inc.Startup

100 Clinical Results associated with Linsitinib

100 Translational Medicine associated with Linsitinib

100 Patents (Medical) associated with Linsitinib

371

Literatures (Medical) associated with Linsitinib

07 Apr 2025·ONCOGENE

Frequent copy number gain of MCL1 is a therapeutic target for osteosarcoma

Article

Author: Fujita, Naoya ; Funauchi, Yuki ; Takemoto, Ai ; Huang, Tianyi ; Takami, Miho ; Sakata, Seiji ; Takagi, Satoshi ; Nakajima, Mikako ; Katayama, Ryohei ; Koike, Sumie ; Sugiura, Yoshiya ; Saito, Masanori ; Baba, Satoko ; Ae, Keisuke ; Takeuchi, Kengo ; Seto, Yosuke

Osteosarcoma (OS) is a primary malignant bone tumor primarily affecting children and adolescents. The lack of progress in drug development for OS is partly due to unidentified actionable oncogenic drivers common to OS. In this study, we demonstrate that copy number gains of MCL1 frequently occur in OS, leading to vulnerability to therapies based on Mcl-1 inhibitors. Fluorescence in situ hybridization analysis of 41 specimens revealed MCL1 amplification in 46.3% of patients with OS. Genetic inhibition of MCL1 induced significant apoptosis in MCL1-amplified OS cells, and the pharmacological efficacy of Mcl-1 inhibitors was correlated with MCL1 copy numbers. Chromosome 1q21.2-3 region, where MCL1 is located, contains multiple genes related to the IGF-1R/PI3K pathway, including PIP5K1A, TARS2, OUTD7B, and ENSA, which also showed increased copy numbers in MCL1-amplified OS cells. Furthermore, combining Mcl-1 inhibitors with IGF-1R inhibitors resulted in synergistic cell death by overcoming drug tolerance conferred by the activation of IGF signaling and suppressed tumor growth in MCL1-amplified OS xenograft models. These results suggest that genomic amplification of MCL1 in the 1q21.2-3 region, which occurred in approximately half of OS patients, may serve as a predictive biomarker for the combination therapy with an Mcl-1 inhibitor and an IGF1R inhibitor.

01 Apr 2025·GLIA

Therapeutic Potential of Growth Hormone in Peripheral Nerve Injury: Enhancing Schwann Cell Proliferation and Migration Through IGF‐1R‐AKT and ERK Signaling Pathways

Article

Author: Zhang, Tingcheng ; Qi, Songtao ; Huang, Liehao ; Guo, Rongrong ; Wang, Chaohu ; Zhang, Huarong ; Liu, Yi ; Niu, Peirong ; Wu, Chengdong ; Wu, Zhiyong ; Chen, Jiaqian

ABSTRACT:

Peripheral nerve injury (PNI) represents a prevalent condition characterized by the demyelination of affected nerves. The challenge of remyelinating these nerves and achieving satisfactory functional recovery has long been a persistent issue. The specific contributions of growth hormone (GH) in the aftermath of PNI have remained ambiguous. Our investigations have demonstrated that GH not only enhances neurological function scores but also promotes remyelination within a three‐week period. Further in vivo studies corroborated that GH facilitates nerve function improvement by mitigating neuronal apoptosis. In vitro, the ideal concentration of GH for exerting effects on Schwann cells (SCs) has been identified as 80 ng/mL. Subsequent research uncovered GH's profound impact on SCs proliferation, cell cycle progression, and migration. Through RNA sequencing and additional experiments, it was discovered that GH treatment elevates the phosphorylation levels of IGF‐1R, AKT, and ERK. Moreover, the GH‐induced proliferation and migration of SCs were significantly diminished by the inhibition of the IGF‐1R pathway, achieved through pre‐treatment with Linsitinib. The outcomes of this investigation suggest that GH can significantly enhance the proliferation and migration of SCs, presenting it as a viable option for PNI repair.

01 Mar 2025·iScience

Targeting insulin-like growth factor 1 receptor restricts development and severity of secondary lymphedema in mice

Article

Author: Yeo, Yong Qiang ; Levy, Sidney M ; Shayan, Ramin ; Karnezis, Tara ; Achen, Marc G ; Yuan, Yinan ; Stacker, Steven A

Secondary lymphedema is a debilitating chronic tissue swelling in a limb caused by inadequate interstitial fluid drainage due to dysfunctional lymphatic vessels. Pathological enlargement of small lymphatics contributes to lymphatic dysfunction in secondary lymphedema, but molecular mechanisms driving this remodeling are unclear. Here, using a surgical mouse model of secondary lymphedema and whole-genome microarray, we identified the transcript for insulin-like growth factor binding protein 5 (IGFBP5), a negative regulator of insulin-like growth factor (IGF) signaling, as the most profoundly down-regulated in lymphedematous tissue. Notably, IGF signaling via IGF1 receptor (IGF1R) was previously shown to promote lymphatic remodeling. We therefore targeted IGF1R in the mouse model using the small molecule IGF1R inhibitor linsitinib. Linsitinib restricted enlargement of small lymphatics and tissue swelling during lymphedema development, likely by inhibiting IGF1R-driven vascular endothelial growth factor-C (VEGF-C) synthesis by macrophages. Importantly, linsitinib profoundly reduced tissue swelling in mice with chronic lymphedema suggesting IGF signaling as a therapeutic target for this disease.

News (Medical) associated with Linsitinib

14 Jan 2025

·www.fiercebiotech.com

Sling\'s oral Tepezza rival hits goal in thyroid eye disease, setting stage for confirmatory phase 3

Convenience is one area Sling Therapeutics may have an edge over the incumbent in thyroid eye disease. \n Sling Therapeutics’ oral challenger to Amgen’s intravenous Tepezza has hit the mark in a phase 2b/3 thyroid eye disease (TED) trial, teeing the biotech up to run a confirmatory study of its ex-Astellas asset. But a cross-trial comparison suggests Amgen’s blockbuster may have the advantage on the efficacy front.Astellas studied the small-molecule IGF-1R inhibitor linsitinib as a cancer treatment. However, with the anti-IGF-1R antibody Tepezza showing the benefits of targeting the receptor in TED, Sling spied a chance to use linsitinib in the eye disease. The biotech launched with $35 million to run a phase 2b trial in TED, a complication of Graves’ disease that causes the eyes to bulge, in 2022.About 18 months later, Sling has evidence linsitinib works in TED. Investigators randomized 90 patients to receive one of two doses of linsitinib or placebo. After 24 weeks, 52% of people on the high dose had a big enough reduction in eye bulging to meet the response criteria.The response rate was significantly higher than in the placebo group, causing the high dose to achieve the primary endpoint. Sling made no mention of the performance of the low dose. The biotech is now preparing to start a confirmatory phase 3 trial this year. Horizon Therapeutics, which brought Tepezza to market before selling up to Amgen, reported a higher response rate in its phase 3 program. After eight infusions across 24 weeks, the response rates in the two Tepezza trials were (PDF) 71% and 83%. Cross-trial comparisons can be misleading, but the available data suggest Sling may need to focus on areas other than efficacy to compete.Convenience is one area Sling may have an edge over the incumbent. Tepezza patients receive 60- to 90-minute infusions every three weeks. Linsitinib is taken orally twice a day. Amgen began a phase 3 trial of a subcutaneous formulation of Tepezza last year, positioning it to potentially free patients from lengthy infusions in the future.Safety and tolerability is another potential battleground. In Tepezza’s phase 3 program, 10% of patients on the drug developed hearing impairment, a catch-all term for conditions such as deafness and tinnitus. Sling said no drug-related hearing impairment was reported in its trial, although there was one unrelated report, and the placebo-adjusted tinnitus rate was 0%. Hyperglycemia was rarer than for Tepezza, too.Sling saw elevated liver enzymes, but they resolved quickly and caused no signs of drug-induced injury, leading the biotech to conclude linsitinib was well tolerated. The planned phase 3 trial will shed more light on the molecule’s safety and efficacy profile and potentially position Sling to challenge Amgen for the TED market.

$Sling\'s oral Tepezza rival hits goal in thyroid eye disease, setting stage for confirmatory phase 3$

Phase 3Clinical ResultPhase 2

14 Jan 2025

·www.prnewswire.com

Sling Therapeutics Announces Positive Topline Results from Phase 2b/3 LIDS Clinical Trial of Oral Small Molecule Linsitinib in Patients with Thyroid Eye Disease

- Linsitinib is the first and only oral small molecule therapy to establish statistical and clinical significance in Thyroid Eye Disease (TED) - Phase 2b/3 LIDS trial met primary endpoint of proptosis reduction with statistical significance at 150mg BID dose - Linsitinib was well-tolerated particularly in IGF-1R areas of interest such as hearing impairment, glycemic changes, and menstrual cycle changes - Confirmatory Phase 3 trial on track to commence in 2025 ANN ARBOR, Mich., Jan. 14, 2025 /PRNewswire/ -- Sling Therapeutics, Inc., a late-stage biopharmaceutical company focused on the development of an oral small molecule for the treatment of thyroid eye disease (TED), today announced topline efficacy and safety data from the Phase 2b/3 LIDS trial of linsitinib in patients with active, moderate to severe TED. Linsitinib, Sling's lead product candidate, is a convenient oral small molecule, taken twice-daily, in clinical development for TED. Linsitinib works by inhibiting the validated IGF-1R target and has an established safety profile through treatment of more than 900 patients across fifteen clinical trials in multiple disease areas. "The positive data from this trial establish the clinical significance of linsitinib and represent the first ever successful clinical trial of an oral small molecule for the treatment of TED," said Ryan Zeidan, Ph.D., President and Chief Executive Officer of Sling Therapeutics. "We believe linsitinib can be a potential new treatment option that could enable a broader number of physicians across multiple therapeutic disciplines to treat patients diagnosed with TED. We are excited to continue our clinical program and are on track to initiate our confirmatory Phase 3 registrational trial later this year." Trial Overview and Topline Results The LIDS Phase 2b/3, randomized, double-masked, placebo-controlled study was designed to evaluate the safety, pharmacokinetics, and efficacy of linsitinib in patients with active, moderate to severe TED. The primary endpoint of the study was the percentage of subjects who were proptosis responders at week 24, defined as at least a two-millimeter reduction in proptosis from baseline. The LIDS trial enrolled 90 patients who were randomized 1:1:1 and received either linsitinib 150mg BID, linsitinib 75mg BID, or placebo for 24 weeks. The trial was conducted globally at 35 sites in five countries. The LIDS trial met its primary endpoint with statistical significance for the 150mg BID dose. Linsitinib in this trial validated the safety profile seen in the prior oncology studies and importantly demonstrated a favorable safety profile on key adverse events (AEs) of interest for the IGF-1R target such as hearing impairment, hyperglycemia, and menstrual cycle changes. Additionally, no QTc prolongation was observed in any patient with rigorous ECG monitoring throughout the study. Key Topline Data: Statistically Significant Proptosis Responder Rate (PRR): PRR was statistically significant and clinically meaningful at the 150mg BID dose, with a PRR of 52% (p = 0.01) at Week 24. Consistent Safety Data, No Drug-Related Hearing Impairments: Linsitinib was well-tolerated and consistent with the safety profile of the previous 15 linsitinib clinical trials, which now includes more than 900 patients in multiple disease areas. Key AE data from the 150mg BID arm include: No drug-related hearing impairment reported (1 unrelated report out of 29 patients) 0% tinnitus placebo-adjusted rate 3% rate of hyperglycemia (1 report out of 29 patients with no intervention required) 0% menstrual cycle changes reported Treatment emergent AEs greater than or equal to 10%: diarrhea (20.7%), headache (20.7%), nausea (20.7%), fatigue (17.2%), ALT increase (17.2%), hyperhidrosis (13.8%), AST increase (10.3%), and muscle spasms (10.3%) Hepatic transaminases were all quickly resolved and not associated with any elevations of total bilirubin, alkaline phosphatase, hepatic dysfunction, or other signs or symptoms of drug-induced liver injury The majority of AEs were either mild or moderate, reversible, and quickly resolved upon treatment pause or discontinuation consistent with a shorter half-life treatment No QTc prolongation was observed in any patient with rigorous monitoring throughout the study "TED is a debilitating auto-immune disorder with limited options available for patients today. Patients must currently choose between an invasive orbital surgery or eight infusions over 24 weeks, which can be inconvenient and time-consuming and pose serious potential risks," said Raymond Douglas, M.D., Ph.D., Professor at Cedars-Sinai Medical Center and KOL and lead investigator in previous TED trials, as well as Chief Scientific Officer at Sling Therapeutics. "In this trial, patients demonstrated significant improvement in disease with no drug-related hearing impairments or significant hyperglycemia. These side effects are the largest barriers for current medical treatments, making linsitinib an important potential new therapy for patients with TED. As a practicing physician, it makes sense to start a new patient's treatment journey with an oral therapy that shows an early response that increases over time." The Company is engaging with regulatory authorities to discuss the confirmatory Phase 3 trial design, which is on track to commence in 2025. Full results of this Phase 2b/3 trial will be presented at an upcoming medical conference. About Linsitinib Linsitinib is a convenient oral small molecule, taken twice-daily and with a short half-life, in clinical development for thyroid eye disease (TED). Linsitinib works by inhibiting the IGF-1R target, which is the only validated clinical target in TED and the only target for current FDA-approved therapies. Activation of the IGF-1R target leads to inflammation and proptosis seen in TED. Linsitinib has an established safety profile through treatment of more than 900 patients in fifteen clinical trials in multiple diseases. About Thyroid Eye Disease (TED) Thyroid Eye Disease (TED) is a serious, progressive, and vision-threatening rare autoimmune disease that affects approximately 70,000 people in the U.S. and has a similar prevalence in the EU. TED often occurs in people living with Graves' disease and hyperthyroidism and is caused by dysfunction in the IGF-1R signaling pathway which results in fibrous tissue growth behind the eyes. This leads to several negative symptoms that may have long-term, irreversible damage as the tissue growth pushes the eyes forward or causes the eyes and eyelids to become red and swollen. As the disease progresses it can lead to pain, eye bulging (proptosis), and double vision (diplopia), thus dramatically impacting a patient's quality of life. TED predominantly affects women, and most frequently affects people with hyperthyroidism due to Graves' disease. Current standard of care typically involves either invasive orbital surgery or a lengthy series of infusions with potential adverse events like loss of hearing, hyperglycemia or menstrual cycle changes. About Sling Therapeutics Sling Therapeutics, Inc., is a late-stage biopharmaceutical company focused on the development of an oral small molecule for the treatment of thyroid eye disease (TED). The company's lead product candidate, linsitinib, works by inhibiting the validated IGF-1R target. It recently completed a Phase 2b/3 clinical trial for the treatment of TED and is on target for initiating its confirmatory Phase 3 trial in 2025. Based on extensive preclinical and clinical data from more than 900 patients, linsitinib offers the potential of a convenient oral small molecule that could significantly reduce the treatment burden for people living with TED while improving and simplifying patient care by physicians and hospitals. For more information, please visit or follow us on LinkedIn or X (formerly known as Twitter). Investor and Media Contact: Argot Partners (212) 600-1902 [email protected] SOURCE Sling Therapeutics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 3

14 Jan 2025

·endpts.com

Regeneron, Illumina invest in Truveta; Inhibrx Bio’s $150M loan

Plus, news about Bioptimus, RhyGaze, Grifols, subcutaneous Leqembi and Sling Therapeutics: Regeneron pours $119.5M into Truveta Series C: Regeneron will also work with the medical data research company to launch a genome project that aims to sequence ten million patient volunteers. Illumina is also investing $20 million into the Series C. – Ayisha Sharma Inhibrx Bio inks loan facility for up to $150M: The funding should give the San Diego-based biotech “strategic flexibility” beyond anticipated data readouts later this year for two of its programs — INBRX-109 and INBRX-106. Inhibrx has so far received an initial $100 million from the five-year term agreement with Oxford Finance. – Ayisha Sharma Bioptimus gets $41M in new financing: The raise brings the company’s total amount to $76 million after it debuted last February with a $35 million seed round. Bioptimus will use the money to “enhance its multi-modal AI platform,” it said in a press release, which may include the ability to sign partnerships with biopharma companies. — Max Gelman Ophthalmic biotech secures $86M in Series A: Basel-based RhyGaze plans to use the proceeds to advance its lead gene therapy candidate designed to restore vision in diseases that cause blindness. Google Ventures led the fundraise, with support from the likes of Novartis Venture Fund and ARCH Venture Partners. – Ayisha Sharma Grifols gets $21M grant for Parkinson’s research: The company received the grant from the Michael J. Fox Foundation for Parkinson’s Research. It will fund a pilot study to analyze plasma samples from Parkinson’s patients for up to 10 years, which the company hopes will help bring about better diagnostic tools and therapeutics for patients. — Max Gelman FDA accepts BLA for subcutaneous Leqembi: Eisai and Biogen are seeking approval for the amyloid-targeting antibody as a weekly maintenance therapy in early Alzheimer’s disease. The agency will issue a decision by Aug. 31. — Elizabeth Cairns Sling’s thyroid eye disease pill hits: The IGF-1R inhibitor linsitinib reduced proptosis (eye bulging) in 52% of Phase 2b/3 trial subjects given the higher 150 mg twice-daily dose for six months. Sling did not give details for the 75 mg dose, but said the drug was well-tolerated. A pivotal Phase 3 trial is expected to start this year. — Elizabeth Cairns

Phase 3Gene Therapy

100 Deals associated with Linsitinib

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D09925	Linsitinib	-	DB06075

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Graves Ophthalmopathy	Phase 3	United States	Sling Therapeutics, Inc.Startup	01 Jul 2022
Graves Ophthalmopathy	Phase 3	Canada	Sling Therapeutics, Inc.Startup	01 Jul 2022
Graves Ophthalmopathy	Phase 3	Italy	Sling Therapeutics, Inc.Startup	01 Jul 2022
Graves Ophthalmopathy	Phase 3	Spain	Sling Therapeutics, Inc.Startup	01 Jul 2022
Graves Ophthalmopathy	Phase 3	United Kingdom	Sling Therapeutics, Inc.Startup	01 Jul 2022
Hashimoto Disease	Phase 3	United States	Sling Therapeutics, Inc.Startup	01 Jul 2022
Hashimoto Disease	Phase 3	Canada	Sling Therapeutics, Inc.Startup	01 Jul 2022
Hashimoto Disease	Phase 3	Italy	Sling Therapeutics, Inc.Startup	01 Jul 2022
Hashimoto Disease	Phase 3	Spain	Sling Therapeutics, Inc.Startup	01 Jul 2022
Hashimoto Disease	Phase 3	United Kingdom	Sling Therapeutics, Inc.Startup	01 Jul 2022

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ENDO2024	Not Applicable	IGF-1R \| TSH-R	-	Linsitinib	wnhnsbfooc(qvfsdlmnav) = qevjgmidhs lfowujbecb (zhvsybdzpr ) View more	Positive	01 Jun 2024
				Teprotumumab	wnhnsbfooc(qvfsdlmnav) = gfjjgnpvpl lfowujbecb (zhvsybdzpr ) View more
NCT01560260 (SARC, Pubmed \| Clin Cancer Res) Manual	Phase 2	Gastrointestinal Stromal Tumors	20	Linsitinib	yebgdippxg(hvflxwikup) = dcvvfybguy vkhhypctgj (prqmagyjzx ) View more	Positive	15 Apr 2020
NCT02546544 (LINES, CTgov)	Phase 2	Recurrent Ewing Sarcoma \| Refractory Ewing Sarcoma	16	Linsitinib	cfqtviolqv(xnvhufqsfl) = tlqwqozzyz sznmwpetok (ylrjgcnrhb, tnibculkjb - emwtvbdckx) View more	-	03 Jun 2019
NCT01186861 (Pubmed \| Med J Aust) Manual	Phase 2	Non-Small Cell Lung Cancer Maintenance	205	erlotinib+linsitinib	paseneuuos(cmbxjdidyl): P-Value = 0.601 View more	Negative	05 Sep 2017
				erlotinib+Placebo
NCT01560260 (SARC, CTgov)	Phase 2	Paraganglioma \| Chondrosarcoma \| Gastrointestinal Stromal Tumors ... View more	20	Pharmacological Study+Linsitinib	yqmiuqardc = qjreimcskh kgxyflzjuo (myxwwixpgq, gnvrtcmhtp - fpbkeciamt) View more	-	19 Jan 2017
NCT01221077 (Pubmed \| Clin Lung Cancer) Manual	Phase 2	Non-Small Cell Lung Cancer	88	erlotinib+Linsitinib	hmsqsoygdg(whoqftphkj) = yhwlorreas lzgylcfctb (pspjpymncd ) View more	Negative	01 Jan 2017
				erlotinib+Placebo	hmsqsoygdg(whoqftphkj) = nscoaecwty lzgylcfctb (pspjpymncd ) View more
NCT01533181 (Pubmed \| Oncologist) Manual	Phase 2	Recurrent Lung Small Cell Carcinoma	44	Topotecan Hydrochloride	mrecujcnav(xwifadyqna) = rtiamczeed ytcbffveqj (dkmfgfvves, 1.5 - 3.6) View more	Negative	01 Oct 2016
				Linsitinib	mrecujcnav(xwifadyqna) = klxjygdutf ytcbffveqj (dkmfgfvves, 1.1 - 1.4) View more
NCT01533181 (CTgov)	Phase 2	Recurrent Lung Small Cell Carcinoma	44	Topotecan (Arm A: Topotecan)	umucwxxqgd(hqiirfrokz) = xugxpzkzqx kohbkkpvom (etxevqidpe, vqyppclbiz - ygwjruskji) View more	-	14 Jan 2016
				OS-906 (Arm B: OS-906)	umucwxxqgd(hqiirfrokz) = tjkilysxxy kohbkkpvom (etxevqidpe, jlvghyuthh - xvefjqkzzr) View more
NCT00924989 (Pubmed \| Lancet Oncol) Manual	Phase 3	Adrenocortical Carcinoma	139	Linsitinib	vwcqrcmxhp(qyugcpkeag) = tdcpayusmi vqympolzze (lzbvxrwlqp )	Negative	01 Apr 2015
				Placebo	vwcqrcmxhp(qyugcpkeag) = njkvhhlecc vqympolzze (lzbvxrwlqp ) View more
NCT01533246 (CTgov)	Phase 2	Recurrent Prostate Carcinoma \| Metastatic Prostate Carcinoma \| Metastatic castration-resistant prostate cancer ... View more	17	laboratory biomarker analysis+linsitinib	iwwofoyljz = dwkzblevoi dkztekrciv (oicyebioak, idzeutcyzu - uzikzbhgtp) View more	-	13 Mar 2015

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