Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

Sorry, we all know this is incorrect.

If the study is positive, there may be a small increase in isradipine sales, but also other CCBs will increase. As I have pointed out, this effect is not unique to Isradipine

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=142537862

At a cost of $23 million for the Phase 3, not to mention multiple millions $$ more for Phase 2, isradipine was not chosen by accident. The calcium channel sub-type (Cav1.3) that is associated with damage to dopaminergic neurons in Parkinson's Disease has a stronger affinity for isradipine than any other CCB's. Other drugs are weaker inhibitors of Cav1.3, and so the therapeutic cardiovascular effect (lower BP) outweighs the neuro-protective effect. Isradipine was the best of the bunch, and the purpose of the isradipine Phase 2 study was to establish the highest dose of isradipine that could be well-tolerated in PD patients without too many side effects due to low BP. They tested 2.5mg BID, 5mg BID, and 10mg BID, and they found the 5mg dose to be the best. This dose has been well-tolerated in the STEADY-PDIII study, with 98% retention rate despite the long 36-month study.

https://www.nature.com/articles/ncomms2149#ref-link-section-12

The predominant (~90%) LTCC in the brain has a CaV1.2 subunit; this channel also is abundant in a variety of peripheral organ systems, including the cardiovascular system and is effectively antagonized by DHPs, accounting for their therapeutic efficacy in hypertension15. However, the LTCC responsible for mitochondrial oxidant stress and increased vulnerability in SNc dopaminergic neurons is largely attributable to expression of LTCCs with a CaV1.3 subunit5,6. Among the DHPs, isradipine has the highest relative affinity for CaV1.3 LTCCs, but it is still CaV1.2 LTCC selective14..

No other CCB's have a higher affinity for CaV1.3 than isradipine. No other CCB's have undergone Phase 2 safety study in Parkinson's Disease. No other CCB's have undergone Phase 3 efficacy study in Parkinson's Disease. No other CCB's will be Rx'ed for Parkinson's Disease. Science!