Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

When Marqibo was acquired, I thought there would be some serious potential as a substitute for vincristine which is used in so many treatments. With Marqibo there is no dose capping and adults would get the full dose. Remember this video

Vincristine in Acute Lymphoblastic Leukemia Published on Jan 7, 2015

[Summary from an old Yahoo post of mine]
In this segment, Dan Douer, MD (Sloan Kettering CC, and Mark R. Litzow, MD, discuss vincristine sulfate liposome injection, Marqibo.
Dan Douer, MD It’s approved for all types of ALL but it’s FDA approved for Ph - ALL but
V has 2 problems 1) Never used as a single agent so it’s not clear what effect 2) almost all adults get a reduced dose 1.4 mg/m2, half the 2 mg so if you are bigger than 1.43 m2 you get the fixed dose of 2 mg. So M allows 2 things pivitol trial w 65 patients (25 patients in P1) CR was 20% (or 28?) 2 fold w xxx negative Overall RR is 35%; Neuropathy rate in the P2 was around 24%. The big Q is what is the importance of getting a full dose especially in combo. I emphasize the overall because there are some conditions that you don’t need to get the full response Dose is 2.25 mg/m2 so higher and is not cut. So everyone is getting more.

And there was some exciting P2 data at ASH in 2013

Abstract # 3033 - Long Term Results Of a Phase 2 Study Of Vincristine Sulfate Liposome Injection (Marqibo®) Substituted For Non-Liposomal Vincristine In CHOP With Or Without Rituximab For Patients With Untreated Aggressive Non-Hodgkin’s Lymphomas
This study evaluated 60 patients with untreated DLBCL in which Marqibo was substituted for Vincristine (VCR) in R-CHOP creating R-CHMP. The primary endpoint was overall response rate (ORR), and secondary endpoints were Progression free survival (PFS) and overall survival (OS). The overall response rate was 95% (57/60) and the complete response rate (CR) was 90% (54/60). Ten year PFS and OS were 64% and 87%, respectively. In patients greater than 60 years of age, overall response rate was 91%, 10 year PFS= 48%, and 10 year OS was 65%. The safety profile of R-CHMP was comparable to what has been reported in the literature for R-CHOP. Grade 3 peripheral neuropathy was 3%. The authors concluded that the R-CHMP “resulted in a high ORR and encouraging PFS and OS without apparent increased toxicity compared to historical experience with R-CHOP. In particular, elderly DLBCL patients with an unfavorable prognosis, based on age-adjusted International Prognostic Index (aaIPI) experienced remarkable PFS and OS.”

But alas, as I complained a couple of months ago in post 2359 (A long-time long's lament (or jealous of SGEN).), Dr Raj would buy these drugs for some revenue but wouldn't develop them further. See what SGEN did w Adcentris that started out in 3rd line CTCL and where it's at now. I couldn't find the patent info but I thought Marqibo would lose its patent around 2019 but I did find this old Yahoo post but I don't know how strong the patent is to any legal fight.

Kingwoep
7 hours ago ~9am 11/16/17
11/15/17 - Patent Issued for Method for the Preparation of Liposome Encapsulated Vincristine for Therapeutic Use (USPTO 9801874)

Method for the preparation of liposome encapsulated vincristine for therapeutic use
Patent number: 9801874
Abstract: Improved methods for efficiently constituting liposome encapsulated vincristine for intravenous injection (VSLI) with reduced risk of operational errors and contamination are disclosed.
Type: Grant
Filed: November 20, 2013
Date of Patent: October 31, 2017
Assignees: Spectrum Pharmaceuticals, Tekmira Pharmaceuticals Corporation
Inventors: William T. Monte, Christopher James Barbosa, Thomas Philip Weber

Anyhows, actions speak louder than words and Spectrum's actions says it all.