On August 17, 2015 shares of Aveo reached as high as 126% in one day after the company announced a partnership with Novartis. Under the terms of the agreement Novartis will make an upfront payment to Aveo for $15 million. This is in exchange for a partnership for both companies to produce the AV-380 compound and all related antibodies of this compound. This compound is being produced to help patients with fat and muscle loss that typically stems from different types of cancer.
If all clinical trials and milestones are met with this product than Aveo stands to make a total of $311 million from Novartis. Aveo has been struggling a lot lately with a lot of its different cancer products in its pipeline. This is especially true with one of its kidney cancer drugs, known as tivozanib, where the FDA rejected the company’s drug back in 2013 citing that the results shown were inconclusive for proper approval.
As mentioned above this AV-380 drug compound targets cancer patients who experience weight and muscle loss, this is known as cancer cachexia. Patients are not able to maintain proper nutrition in their bodies which causes a multitude of symptoms ranging from fatigue and the inability to do daily routine tasks.
Omeros Corporation (NASDAQ:OMER)
On August 18, 2015 shares of Omeros closed the trading day up 72% after it had announced positive phase 2 results for its trial in patients with thrombotic microangiopathies or TMAs. These TMAs occur when small blood vessels become blocked in vital organs such as the Kidney for example. This disease is considered life threatening because if blood can’t flow properly to organs in the body then there is the possibility of blood clots.
The phase 2 results showed positive efficacy because of the improvement of platelet counts found in these patients. The more platelet counts your body has the better it is for your blood flow. For instance the mid-dosing of the trial saw two patients improve their platelet counts by 48%. Even going to the high-level dosing one patient saw a 68% improvement in their platelet counts. This is a major improvement as these patients do not have such a high transfer throughout the body of their platelet counts.
The next step for this program is for Omeros to set up a meeting with the FDA to possibly discuss a potential phase 3 trial to treat these patients with TMAs. If eventually successful the company can then file for FDA approval of this drug product. The company’s drug product to treat these patients with TMAs is known as OMS721. Because this drug compound did not have a comparative placebo compound to be tested against other means were necessary to establish efficacy. Instead the company measured the mean change of each patient from baseline to determine how much efficacy the drug could produce.
Vital Therapies (NASDAQ:VTL)
On August 21, 2015 shares of Vital Therapies nose-dived by 75% in after-hours trading after the company had reported that it had failed a pivotal phase 3 trial. This phase 3 trial, known as the VTI-208 trial, used the company’s ELAD system to act as a cell-based liver support in patients with alcohol-induced liver decompensation — AILD.
This phase 3 trial enrolled approximately 203 patients who either took the company’s ELAD system or a control product. The primary endpoint of the trial was overall survival of the patients by the 91 days time point. The trial failed to meet the primary endpoint and the efficacy of the overall survival was established using a scale known as Kaplan Meier Statistical Method.
The trial failing to meet on the primary endpoint is bad enough but the company also stated that it had failed on the secondary endpoint as well. In order for the ELAD system to pass the secondary endpoint compared to placebo it had to achieve an efficient p-value. This p-value was established using a scoring system known as Pearson’s Chi-Squared P-values. On day 28 of the analysis the company concluded that the p-value was 0.45 — which is not statistically significant.
On day 91 of the analysis the p-value was 0.74 which was also not statistically significant. The fact that that Vital didn’t see a passing of either the primary endpoint or secondary endpoint does not bode well for the future of this product. Was there any good news that stemmed from this trial? Well the only good news was the fact that there was an exploratory endpoint in which 120 patients were partially improved with the ELAD system. The next step now is for the company to meet with the FDA and determine if this VTI-208 trial has any possible future left. Just in case the FDA will allow the company to advance to another trial, Vital has $66 million in cash on its balance sheet.