This could be pointing to an indication for iPlex in addition to ROP, namely diabetic retinopathy.
Google " IGFBP3 suppresses retinopathy through suppression of oxygen-induced vessel loss and promotion of vascular regrowth" From the abstract : "How IGFBP3 modulates angiogenesis is important because the IGF1/IGFBP3 combination is now available for clinical use. Premature infants and diabetic individuals are at risk for vascular loss as well as proliferative retinopathy. In diabetes, loss of insulin and hyperglycemia over time precipitates vessel loss and leads to retinal ischemia. Hypoxia induces the formation of morphologically abnormal neovascularization (NV), as well as apoptotic neuronal cell death in the retina, causing retinal degeneration. If vascular loss can be prevented, proliferative retinopathy, driven by the resultant hypoxia, will also be suppressed." Could this indication could be worth more than $11.5 million?
FUD, it's interesting you mention the wide are of diabetes. In 2002, Insmed discontinued its' work on INS-1 for diabetes. They then concentrated on Somatokine (Iplex). I can't help but think that INS-1 still has some usefulness to Insmed. See the article below....maybe Zake can provide some more information or thoughts.
Insmed Discontinues Internal Development of INS-1 for Diabetes and Polycystic Ovary Syndrome - PCOS -
Decision Follows Results of Phase II Clinical Trials Company Will Direct Resources Toward Most Promising Clinical Drug Candidates Insmed Continues Its Commitment to Develop Drugs for Diabetes and PCOS
Insmed Incorporated today announced that it has discontinued its internal development of INS-1, one of its investigational drug candidates for type 2 diabetes and polycystic ovary syndrome (PCOS). The decision not to proceed was based on the results of recently completed Phase II clinical trials. In a recently completed clinical trial in patients with type 2 diabetes, INS-1 was safe and well tolerated but did not achieve statistical significance on its primary efficacy measures. These efficacy results failed to corroborate those reported in several previous studies.
In recently completed clinical trials in patients with PCOS, INS-1 was safe and well tolerated but did not achieve statistical significance on its primary efficacy measures. Although an overall increase in ovulation rates was not achieved, an increased number of pregnancies occurred in the INS-1 treated patients. The company is currently evaluating the clinical relevance of this observation and whether it warrants further investigation.
"Obviously, we are disappointed with these results," said Geoffrey Allan, Ph.D., president and chief executive officer of Insmed. "Nevertheless, we believe we have an impressive pipeline, an outstanding clinical development team and several exciting Phase II
More promising perhaps is the use of the protein complex in the treatment of Diabetes.
That seems to have been the initial target - back-burnered after a link emerged between IGF-1 therapy and an increased risk of retinopathy in diabetics.
I believe it was this development which was at least partly responsible for Genentech's decision to abandon the development of IGF-1 - which itself prompted the formation of Tercica, to develop IGF-1 under license from Genentech.
As you noted, the presence of IGFBP-3 has the potential to prevent the development of diabetic retinopathy. But the emergence of that risk necessitated a clinical trial program involving large numbers of participants - out of the reach of Insmed without a partner.
No big pharma was going to partner with the risk of a patent infringement verdict. Insmed changed course to Short stature - a far smaller study it could finance on its own.
But every iPlex study ever conducted, including the MMD study, has suggested likely efficacy against insulin resistance (the main problem in Diabetes).
You know, it's not just diabetic retinopathy, Iplex could also become a front-line treatment to prevent the ravages of Alzheimers, helping to control the blood glucose levels in the brain. Shire is going to be a long-term partner with Insmed in the development of Iplex across many indications. I have no doubt!