TRIMERIS T-20 DRUG TRIAL DESIGN FLAWED – RESULTS QUESTIONED
LAS VEGAS – SEPTEMBER 12, Pluvia Securities Research Initiates Coverage of Trimeris, Inc. (Nasdaq: TRMS.O) at the current price of $67 with a STRONG SELL Recommendation and a target price under $18.
Our Strong Sell Recommendation is based on design flaws in the Trimeris phase II T-20 trials that appear to incorrectly attribute success in HIV viral load reduction to their T-20 drug; and, A 1999 J. Durant study that suggests much of the HIV viral reduction experienced in the T-20 trial was the result of other, new anti-HIV drugs introduced to patients in the trial – not T-20.
Issues to consider:
1. The Trimeris T-20 Phase II drug trials introduced 2 new variables to patients; the T-20 drug, and a new anti-HIV cocktail of drugs - selected specifically to attack each patient’s mutated HIV strain using “Genotyping”.
2. A 1999 study by J Durant, published in Lancet concludes the use of an anti-HIV cocktail of drugs selected by a Genotyping process, produced “significant” viral load reductions in treated patients… http://www.findarticles.com/cf_0/m0833/9171_353/55942013/p1/article.jhtml
The Lancet/Durant study ONLY provided patients with a new Genotype selected, ant-HIV cocktail of drugs. The Trimeris Phase II T-20 study also used a Genotype selected, anti-HIV cocktail of drugs – and T-20. trimeris.com
Note both studies produced similar excellent results. Specifically, 32% of patients in the Lancet/Durant study turned HIV negative/undetectable after 6 months of treatment. This compares to 33% of patients in the T-20 Phase II trial who turned HIV negative/undetectable after 48 months.
3. Wall Street analysts have attributed the excellent T-20 Phase II results to the use of T-20. Results of the ‘99 Lancet/Durant study suggest a great deal of credit for the reduced viral load could have been attributed to the Genotype selected anti-HIV cocktail used in conjunction with T-20. Not T-20 alone.
4. Considering the similar excellent study results between the Lancet/Durant study and the Trimeris Phase II T-20 study, where a primary difference between studies was the use of T-20, we question what anti-HIV role T-20 actually played in that study. Furthermore, if effects of the anti-HIV cocktail were backed out of the T-20 study – we question what effect T-20 alone would have produced.
5. Upcoming FDA Phase III trials for T-20 will require the role of T-20 alone to be identified. Without the positive effects produced by a genotype selected anti-HIV cocktail, it will be difficult and likely impossible for T-20 Phase III results to re-produce the same excellent results shown in the flawed T-20 Phase II study.
6. Trimeris may be liable for damages suffered by shareholders who bought stock based on excellent Phase II study results that management knows are being wrongly attributed to T-20.
Overview Of Trimeris
Trimeris is developing two primary drugs T-20, and T-1249. Both are HIV fusion inhibitors and both were granted fast track designation by the FDA. T-20 is in the late stages of Phase II clinical trials while T-1249 is in Phase I clinical trial. The company has a collaborative agreement with F. Hoffmann-La Roche Ltd to develop and market T-20 and T-1249 worldwide. Currently the company is well capitalized with $97.7 million in cash/cash equivalents and short-term investments as of June 30, 2000.
With only 2 drugs in clinical trial, T-20 is clearly a very important drug to Trimeris. Failure of the drug in clinical trials would be a significant setback.
Genotype Testing
Drug-resistance mutations in HIV reverse-transcriptase and protease genes lead to lower sensitivity to antiretroviral agents and are an important cause of drug failure. Both the Durant and the Trimeris T-20 study selected patients who had previously failed HIV drug therapies. Both studies used Genotype testing to identify new anti-HIV drugs to most effectively treat the patient’s mutated HIV.
Results of the 1999 Durant study suggest the Genotype selected anti-HIV cocktail was the cause for their study success. Trimeris’s T-20 trial results seem to ignore the Durant study, ignore the effect of the Genotype selected anti-HIV drugs used in their study, and point to T-20 as the reason for strong antiviral results. The Durant research suggests Trimeris’s conclusions are flawed.
Future Phase III T-20 studies will be forced to isolate effects of T-20. Without the positive contribution of the Genotype selected anti-HIV drugs, it seems likely anti-HIV effects attributed to T-20 in their future Phase III trials will prove less significant than current Phase II findings.
We commend Trimeris management and all others in the field of HIV research for their efforts. Furthermore, we hope future T-20 trials prove it to be an effective HIV fusion inhibitor. But at this time, it would appear as though flawed Phase II trial designs for T-20 have raised false hopes for T-20.
For these reasons, Pluvia Securities Research issues a Strong Sell Recommendation on TRMS with a 6-month price target of under $18. Pluvia Securities Research will maintain research coverage of Trimeris and update future findings.
Pluvia Securities Research, their agents, associates, and or employees have investment positions consistent with the above-stated investment opinion. All comments are the EXPRESS opinion of the Author(s) - All rights reserved.
CONTACT:
Pluvia Securities Research
Steve Pluvia
e-mail pluvia2@aol.com |
