Non-Hodgkins Lymphoma Vaccine Shows Promise (ABPI, BVTI)
Biovest International, Inc. (OTCBB:BVTI) is a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI). This morning the company has what appears to be some very positive cancer vaccine data. It released clinically and statistically significant unblinded data from a randomized controlled pivotal Phase 3 Fast-Tracked clinical trial of BiovaxID(R) (personalized anti-idiotype vaccine). This is for the treatment of indolent follicular non-Hodgkin’s lymphoma (NHL), which is an often fatal blood cancer.
This was originally developed and advanced into human clinical trials by the National Cancer Institute, and BiovaxID is designed to recruit the immune system to recognize and destroy only cancerous B-cells. Based on the highly encouraging clinical evidence reporting on vaccinated patients to date, Biovest plans to proceed with plans to seek accelerated
and/or conditional regulatory approvals in the U.S. and European Union.
The first result for vaccinated patients followed up to 80 months showed that the overall results showed that BiovaxID improved median disease-free-survival by more than one year with the control arm showing a median time to relapse from first vaccination of 21.2 months. This was compared to the BiovaxID arm which had a median time to relapse of 33.8 months. This statistically significant difference represents an increase of approximately 60% in the duration of complete remission since first vaccination. Disease-free survival was the primary endpoint of the study.
The second result for these same patients measured at 36 months from vaccination, BiovaxID improved median disease-free-survival by approximately 100% – a statistically significant improvement as compared to the control group.
So far after 90 minutes of trading (11:00 AM EST) we have seen Accentia (ABPI) trade up over 10% at $0.94 and Biovest (BVTI) is up by more than 50% at $0.51 today.
Jon Ogg
July 17, 2008
Anti-Cancer Vaccine Data Creates Two Huge Moves (BVTI, ABPI)
There are two tiny stocks that are benefiting from some positive Phase III data on an anti-cancer vaccine. Biovest International, Inc. (OTCBB: BVTI) is a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (NASDAQ: ABPI), and this morning the company reported what it noted as “the company believes” to be highly encouraging blinded results from its randomized controlled pivotal Phase 3 Fast-Tracked clinical trial of BiovaxID® for the treatment of indolent follicular non-Hodgkin’s lymphoma. This is an often fatal blood cancer.
It reported a blinded disease-free survival data for patients that have completed 36 months of follow-up subsequent to randomization in both the treatment and control arms, with one arm demonstrating 100% improvement in disease-free survival over the other arm.
Disease-free survival (how long patients remain in cancer-free remission) is the primary endpoint of the study. With a “fast track designation” from the FDA and with a 100% improvement over the other arm, you can imagine the interest in such a small company.
Accentia Biopharmaceuticals, Inc. (ABPI) has a mere $61.5 million market cap and that is after a 24% gain today to $1.36. Its 52-week trading range is $0.65 to $3.39. As of March 31, 2008, its balance sheet was inverted and that doesn’t make this any assured home run by a financial count. Biovest International (BVTI) is seeing a surge of 26% to $0.52 today, and its market cap is only about $50 million.
Jon Ogg
June 11, 2008
Pharmacyclics Scores on Non-Hodgkins Lymphoma Data (PCYC)
Pharmacyclics Inc. (NASDAQ: PCYC) is seeing shares surge today after it said that its Phase 1/2 trial of motexafin gadolinium plus antibody targeted radiation therapy demonstrated a high complete response rate in patients with non-Hodgkin’s lymphoma. The results of the study showed a 46% complete response rate in patients with multiply recurrent non-Hodgkin’s lymphoma who were treated with motexafin gadolinium in combination with Yttrium-90 Ibritumomab Tiuxetan, an approved antibody-targeted radiation therapy.
Patients were treated with a standard dose of Zevalin administered with 2.5 to 5.0 mg/kg of MGd given for six days. Of the 28 evaluable patients in the study, 46% showed a complete response and 11% more showed a partial response. Rituximab refractory patients showed an overall response rate of 86%, with a 64% complete response rate and a median time to progression of 14 months.
Adverse events seen were related to bone marrow suppression, an expected side effect of treatment with Zevalin.
This data was part of a presentation at the International Conference on Malignant Lymphoma. Shares are up some 19% at $1.25 today on more than 5-times volume. Its 520week trading range is $0.55 to $3.28 and its market cap is a mere $32.5 million even after the run. As of last quarter, it had roughly $21 million in liquidity from cash and equivalents.
Jon Ogg
June 5, 2008
Biotech Implosion: Favrille (FVRL)
Favrille, Inc. (NASDAQ: FVRL) may have just joined the realm of biotech zombies this morning, or close to it. The company announced Phase III results which failed to show statistically significant improvement in its primary endpoint, and this was the registration trial of Specifid following Rituxan in patients with follicular B-cell non-Hodgkin’s lymphoma.
The primary endpoint was to measure analysis of time to progression, and it failed to show a statistically significant improvement in the treatment arm. The arms were Specifid plus Leukine following Rituxan compared to the control arm of placebo plus Leukine following Rituxan.
Analysis of all subgroups also did not show any significant differences in primary or secondary endpoints when adjusted for prognostic factors.
This one was only a $71.8 million market cap before the implosion. Now shares are down 80% pre-market at $0.35.
The good news is that the $25 million in tangible book value may let it find some support after that huge drop. The bad news is that this lead candidate failure puts the company back into mostly pre-clinical stage for other products.
Technically this can’t be considered a zombie because it has other pre-clinical candidates. But try telling that to someone coming in from a 3-day weekend and seeing an 80% drop at the open. This was already down well over 50% in the last year before this.
Jon Ogg
May 27, 2008
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