Six-month Lucentis data is bullish for Squalamine:
>> [drbio]: I believe genentech released some data at the aao meeting which referred to a subset of patients that had a 40[%] improvement at 6 months <<
drbio: This is old news that was released back in August. When given every month for six months as part of a trial extension to the phase-1/2 trial, Lucentis showed improved vision (gain of 3+ lines) in 18 of 40 patients (45%). On an intent-to-treat basis, the improved-vision rate was only 18/53 (34%) because 11 patients elected not to participate in the trial extension and 2 patients dropped out during the extension. Hence, on an intent-to-treat basis, the six-month Lucentis data with treatment every month showed essentially the same efficacy as the Squalamine 2-month interim data (in which patients were evaluated one-month after the end of treatment). Moreover, the Lucentis phase-1/2 trial excluded patients with occult AMD (generally the most difficult group to treat) while GENR’s Squalamine trial included occult patients in the mix.
The 6-month Lucentis data has been touted as stellar, but I find it bullish for Squalamine that the efficacy of the two drugs is comparable even though Lucentis patients had to receive a needle in the eye every month for six months.
Here is the Genentech PR from August describing the results. Note that the phase-3 trials mentioned at the end of the PR are having trouble enrolling patients according to Genentech’s own statements.
>> Genentech Presents Positive Preliminary Six-Month Data from Phase Ib/II Study for Lucentis in Age-Related Macular Degeneration (AMD)
New York -- August 18, 2003 -- Genentech (NYSE:DNA) today announced preliminary data from the extension phase of an open-label Phase Ib/II randomized, single-agent study with the investigational anti-angiogenesis product, Lucentis™ (ranibizumab), formerly known as rhuFab V2, for patients with the wet form of age-related macular degeneration (AMD). Lucentis is a humanized, therapeutic antibody fragment that is designed to bind to and inhibit VEGF (vascular endothelial growth factor), a protein that is believed to play a critical role in angiogenesis, the formation of new blood vessels and in regulating vascular permeability. Data from this study is being presented today at The 21st Annual Meeting of the American Society of Retina Specialists in New York City.
"The data from this study appear to indicate that most patients not only continued to maintain vision, but improved their vision when Lucentis therapy was extended to six months and beyond," said Hal Barron, M.D., FACC, Genentech's vice president, Medical Affairs. "Furthermore, patients initially showing a decline in visual acuity in the usual care group experienced an improvement in visual acuity upon crossing over to receive Lucentis. The fact that visual acuity continued to improve during extended Lucentis treatment suggests that a patient's response can be durable, an important potential benefit for patients with this normally progressive disease."
In the first treatment period (98 days), 64 patients with minimally classic and predominantly classic wet AMD were entered into the single-agent, multi-center trial. Patients were treated every four weeks for four doses (either 300 or 500 micrograms) of Lucentis (n=53) or with usual care of observation or photodynamic therapy (n=11). After Day 98, patients in the usual care group were permitted to cross over to receive Lucentis. All patients were monitored for safety and visual acuity, which is defined as the total number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart. Stable vision is defined as losing or gaining fewer than 15 letters on the ETDRS chart compared with the baseline.
Of the 53 patients who received Lucentis during the first treatment period, 42 patients continued with Lucentis for the second treatment period with 40 patients completing the study through Day 210. The visual acuity at Day 98 in patients who continued with treatment improved by an average of 7.4 letters (n=20) in the 300 microgram group and 12.6 letters (n=22) in the 500 microgram group. At Day 210, their visual acuity improved further to an average gain of 12.8 letters (n=19) in the 300 microgram group and 15.0 letters (n=21) in the 500 microgram group compared with the baseline.
While patients receiving usual care demonstrated an average loss in visual acuity of 5.1 letters (n=11) at Day 98, those who crossed over to Lucentis improved on the average by 7.3 letters (n=4) and 3.2 letters (n=5) at Day 210 compared with the baseline in the 300 and 500 microgram groups, respectively. Of the 40 patients who were treated with Lucentis for six months and completed the study through Day 210, 97.5 percent (n=39) of patients had stable or improved vision at Day 210, of which 45 percent (n=18) improved 15 letters or more on the ETDRS chart.
The most common side effects from treatment with Lucentis were mild transient, reversible inflammation. Adverse events were similar in the first and extended treatment periods. There were three serious adverse events of endophthalmitis (infection), recurrent uveitis (inflammation) and central retinal vein occlusion, all of which were successfully treated or resolved.
Phase III Clinical Trials Currently Enrolling Genentech is currently enrolling patients into two Phase III clinical trials for Lucentis. The first trial, called MARINA, is a randomized, multi-center, double-masked, sham-injection controlled study evaluating the safety and efficacy of two different doses of Lucentis in approximately 720 patients with minimally classic or occult wet AMD. The second trial, called ANCHOR, is a randomized, multi-center, double-masked, active treatment-controlled, Phase III study comparing two different doses of Lucentis to verteporfin photodynamic therapy in approximately 426 patients with predominantly classic wet AMD. <<
The analogy with inhaled insulin is well-taken, IMO.
While NKTR and ALKS continue to talk up the prospects for their inhaled-insulin products eventually getting to market, you get quite a different tune when you listen to PFE and LLY, which are NKTR’s and ALKS’ inhaled-insulin partners, respectively.
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