A New Look At Galena's NeuVax While Lowering Analyst's Raised Red Flags [View article]
Rich
Nice work! Regarding 11% patients treated with Herceptin, I believe 11% applies to all patients in the treatment group. Have you come across % of patients treated with Herceptin from the subgroup of 53 patients where they were boosted at least once? What is the impact of Herceptin on this subgroup?
A New Look At Galena's NeuVax While Lowering Analyst's Raised Red Flags [View article]
Comments from Adam F
Returning to Galena Biopharma and Neuvax from yesterday's poster and chat with investigator Dr. George Peoples:
The ASCO poster results were little changed from the abstract released in May. In the subgroup of 53 patients with "boosted" Neuvax injections, the recurrence rate was 3.8% vs 18.9% for the control. Median follow up 60 months.
The DFS rate for Neuvax was 96.2% vs 80.5% for control, the latter slightly lower than my previous calculation of 81.1% due to patient censoring.
The poster contained new info on baseline data for the boosted group which also shows (in my opinion) overall imbalances that favor Neuvax (control patients sicker.) In particular, 23% of Neuvax boosted patients received Herceptin vs. 4% of the control patients -- this difference was stat sig.
The difference was highlighted in red in the poster because it is a potentially confounding factor. Peoples acknowledged this potential issue but also said if you remove these patients from the analysis, the difference in recurrence rate still favors NeuVax.
As i said yesterday, Dr. Peoples was very gracious to answer my questions. Overall, i found him willing to acknowledge the shortcoming of the ph 2 study while still defending NeuVax and maintaining his optimism for the results. Very professional and I thank him for his time.
The risks I outlined in previous columns about Neuvax remain. The best results from the ph 2 were derived from retrospective analyses that raise the risk for the ongoing ph 3. For instance, Peoples told me that he expected Neuvax to work better in HER2 over-expressers (3+) than in low HER2 expressers.
He now believes, based on some other research, that overexpression of HER2 downregulates HLA, which prevents NeuVax from stimulating the immune response necessary to target breast cancer cells. this is why the vax doesn't work in HER2 overexpressers but may work in patients with low HER2 expression, he says.
Interesting theory but again, now it needs to be proven in ph 3.
Peoples acknowledged the limitations of the ph 2. My sense of our discussion is that if he had more resources at his disposal, he would have liked to conduct further ph 2 studies to better validate Neuvax before going into a ph 3. That didn't happen, so the ph 3 study is a roll of the dice.
this is the all-too-common problem with underfunded small-cap companies trying to develop drugs. They rush into ph 3 with underwhelming ph 2 data, which raises the risk of failure.
So, my opinion on GALE hasn't changed. You cannot dismiss the fact that NeuVax was essentially left for dead when under the control of Apthera. Really good oncology assets are rarely overlooked even in a bad economy. That RXII (now Galena) was able to buy phase III-ready NeuVax for $7M tells you a lot about the risk and the skepticism of the previous data.
You also shouldn't dismiss the data-mining which forms the basis for the ph 3 patient population. If this was a real drug/vaccine, we would have seen more robust results overall. We didn't.
But i wish Peoples good luck with the Neuvax ph 3. I also wish GALE CEO Mark Ahn would learn a lesson from Peoples and spend less time over-hyping his drug. He's not fooling anyone. (Well, almost no one)
Breast Cancer Immunotherapy: A New Hope In The Fight [View article]
Regarding E37 and Antigen Express, it is all fine and dandy to talk about initiation of the phase 3 trial but they have yet to show statistically significant reduction in breast cancer recurrence in phase 2. I just can't imagine initiation of phase 3 trial with SPA without statistically significant result from phase 2. It looks like they have some work to do prior to initiation of the phase 3 trial.
Galena Investors Are A Strange Brew [View article]
If one sells shares before the payment date and after record date, they will lose right to get bonus shares. There is a major misunderstanding regarding these dates.
Galena Biopharma: An Emerging Biotech Company With Promising Cancer Vaccines [View article]
Grant thank you for your response. Any word on how the enrollment is coming along and what is the anticipated timeframe for enrollment completion for the phase III trial?
Galena Biopharma: An Emerging Biotech Company With Promising Cancer Vaccines [View article]
Second phase III clinical trial info is based on old information prior to SPA with FDA. If you check the latest company presentation containing milestones there is no second phase III trial mentioned prior to FDA submission. Is there any latest info available indicating need for second phase III trial?
Illogical Biotech Valuations Create Value And Value Traps [View article]
There is no mention of Galena and Roche relationship. Galena teaming up with Roche/Genentech to test NeuVax is a very important milestone for this tiny company. Anytime company like this partners with company like Genentech, who is a pioneer in cancer treatment and delivered blockbuster after blockbuster is huge. I would not be surprised one bit if we wake up to a news one morning in near future where Galena has partnered with company like Roche to commercialize NeuVax. This news alone will increase the market cap by 4-5 folds.
A New Look At Galena's NeuVax While Lowering Analyst's Raised Red Flags [View article]
Nice work! Regarding 11% patients treated with Herceptin, I believe 11% applies to all patients in the treatment group. Have you come across % of patients treated with Herceptin from the subgroup of 53 patients where they were boosted at least once? What is the impact of Herceptin on this subgroup?
A New Look At Galena's NeuVax While Lowering Analyst's Raised Red Flags [View article]
Returning to Galena Biopharma and Neuvax from yesterday's poster and chat with investigator Dr. George Peoples:
The ASCO poster results were little changed from the abstract released in May. In the subgroup of 53 patients with "boosted" Neuvax injections, the recurrence rate was 3.8% vs 18.9% for the control. Median follow up 60 months.
The DFS rate for Neuvax was 96.2% vs 80.5% for control, the latter slightly lower than my previous calculation of 81.1% due to patient censoring.
The poster contained new info on baseline data for the boosted group which also shows (in my opinion) overall imbalances that favor Neuvax (control patients sicker.) In particular, 23% of Neuvax boosted patients received Herceptin vs. 4% of the control patients -- this difference was stat sig.
The difference was highlighted in red in the poster because it is a potentially confounding factor. Peoples acknowledged this potential issue but also said if you remove these patients from the analysis, the difference in recurrence rate still favors NeuVax.
As i said yesterday, Dr. Peoples was very gracious to answer my questions. Overall, i found him willing to acknowledge the shortcoming of the ph 2 study while still defending NeuVax and maintaining his optimism for the results. Very professional and I thank him for his time.
The risks I outlined in previous columns about Neuvax remain. The best results from the ph 2 were derived from retrospective analyses that raise the risk for the ongoing ph 3. For instance, Peoples told me that he expected Neuvax to work better in HER2 over-expressers (3+) than in low HER2 expressers.
He now believes, based on some other research, that overexpression of HER2 downregulates HLA, which prevents NeuVax from stimulating the immune response necessary to target breast cancer cells. this is why the vax doesn't work in HER2 overexpressers but may work in patients with low HER2 expression, he says.
Interesting theory but again, now it needs to be proven in ph 3.
Peoples acknowledged the limitations of the ph 2. My sense of our discussion is that if he had more resources at his disposal, he would have liked to conduct further ph 2 studies to better validate Neuvax before going into a ph 3. That didn't happen, so the ph 3 study is a roll of the dice.
this is the all-too-common problem with underfunded small-cap companies trying to develop drugs. They rush into ph 3 with underwhelming ph 2 data, which raises the risk of failure.
So, my opinion on GALE hasn't changed. You cannot dismiss the fact that NeuVax was essentially left for dead when under the control of Apthera. Really good oncology assets are rarely overlooked even in a bad economy. That RXII (now Galena) was able to buy phase III-ready NeuVax for $7M tells you a lot about the risk and the skepticism of the previous data.
You also shouldn't dismiss the data-mining which forms the basis for the ph 3 patient population. If this was a real drug/vaccine, we would have seen more robust results overall. We didn't.
But i wish Peoples good luck with the Neuvax ph 3. I also wish GALE CEO Mark Ahn would learn a lesson from Peoples and spend less time over-hyping his drug. He's not fooling anyone. (Well, almost no one)
A Short Interview With Galena CEO Dr. Ahn To Address Recent Concerns [View article]
A Short Interview With Galena CEO Dr. Ahn To Address Recent Concerns [View article]
Breast Cancer Immunotherapy: A New Hope In The Fight [View article]
Galena Investors Are A Strange Brew [View article]
http://1.usa.gov/yFkCjo
Galena Investors Are A Strange Brew [View article]
Galena Investors Are A Strange Brew [View article]
Galena Biopharma: An Emerging Biotech Company With Promising Cancer Vaccines [View article]
Galena Biopharma: An Emerging Biotech Company With Promising Cancer Vaccines [View article]
Illogical Biotech Valuations Create Value And Value Traps [View article]